BioProcess International Conference & Expositionmicrosite.sartorius.com/fileadmin/newsletter/france/PDF/Issue_8/...BioProcess International Conference & Exposition The largest bioprocessing

BioProcess InternationalConference & Exposition

The largest bioprocessing event bringing you the science, technologies and partners needed to accelerate promising biologics towards commercial success

October 4TH-7TH, 2016 ❘ Boston, Massachusetts

The largest exposition

devoted to biomanufacturing

The right partners for you

The most

innovative science

Event Partners

Register by June 24TH and Save up to $600 ❘ BPIevent.com

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THE GLOBAL MEETING PLACE FOR BIOPROCESSING SCIENCE, TECHNOLOGY AND NETWORKING

1,800+BIOPROCESSINGPROFESSIONALSAchieve clinical and commercial success by collaborating with leading pharma, biotechs, academia and solution providers from across the globe.

225+TOP-LEVEL SPEAKERS Improve integration, productivity and cost savings in your current line of work by hearing case studies and new data from experts working across the entire bioprocessing spectrum.

160+EXHIBITORS Accelerate your drug product to market by accessing innovative products and technologies in the largest exposition hall devoted to biopharmaceutical manufacturing.

100+PEER-SUBMITTEDPOSTERS Stay at the forefront of bioprocess innovation by accessing new data from fellow attendees.

"BPI was a great, great conference. I enjoyed the presentations, discussions and networking."– Saeko Tanaka, Bioprocess Engineer, Chugai Pharmaceutical Co., Ltd, Japan

"This conference is a great place to meet the technical experts in the industry. I enjoyed exchanging research ideas with global companies and sparking new collaboration."– Kelvin Lau, Senior Process Engineer, Abbott

"BPI was a great success and I absolutely enjoyed every moment of it. I'm looking forward to next year."– Rahul Godawat, Senior Scientist, Genzyme Sanofi

For up-to-date program information and new abstracts, visit: www.IBCLifeSciences.com/BPI

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FierceBiotechTHE BIOTECH INDUSTRY’S DAILY MONITOR

MEDIA PARTNERS:

6 CONTENT-DRIVEN TRACKSMANUFACTURING STRATEGY

ANALYTICAL, FORMULATION AND QUALITY

CELL CULTURE & UPSTREAM PROCESSING

RECOVERY & PURIFICATION

DRUG PRODUCT MANUFACTURING & FILL-FINISH PROCESSING

EARLY STAGE BIOLOGICS AND COMPANIES

Reduce costs, increase yield and remain flexible in your biomanufacturing operations by applying best practices and disruptive technologies used by manufacturing and facility experts from around the world.

Stay abreast of analytical tools and formulation strategies to ensure your products meet increasing quality expectations and regulatory standards by gaining guidance from industry thought leaders and regulators.

Accelerating timelines for mAbs and novel modalities utilizing novel technologies, methodologies, and processing platforms while controlling COGs and optimizing efficiency, productivity, and quality from early stage development to commercial scale manufacturing.

Applying innovative technologies, platforms, and approaches to accelerate and streamline downstream process development to improve COGs; operational capacity and efficiency; process characterization, control and quality of an ever expanding pipeline of novel molecules.

Accelerate your drug substance towards a finished drug product by integrating technologies and strategies to improve the interface between drug substance development and drug product manufacturing/fill-finish processing.

Learn how to successfully transition your biologic from discovery through clinical trials and beyond by hearing guidance from experts on how to reduce risk, minimize costs, navigate funding milestones and decrease time to IND and later stage development.

Register Early for Best Savings • www.IBCLifeSciences.com/BPI • 800-390-4078

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AGENDA AT-A-GLANCE Tuesday, October 4, 2016 • Pre-Conference Symposia

9:00-5:00Continuous Processing

Sponsored by: Pall Life SciencesSupply Chain Security and Transparency from

Starting Materials to PatientCell-Based Immunotherapies-

From Concept to CommercializationProgram Management of Biologics Development Modern CMC Regulatory Strategies Two-Day Training Courses

7:30 BPI “BioBrew” Networking Event @ Harpoon Brewery – Sponsored by Kaneka & Pall Life Sciences (limited capacity; registration required)

Wednesday, October 5, 2016 • Main Conference Exposition Hall Hours: 4:30 pm-6:30 pm

Cell Culture & Upstream Processing Recovery & Purification Drug Product Manufacturing

& Fill-Finish Processing Manufacturing Strategy Analytical, Formulation & QualityTwo-Day Training Courses

7:55-9:30 Optimizing the Transition into Early Stage

DevelopmentInnovation at the Interface of Upstream and

Downstream Processing Drug Product-Fill Finish Case Studies and

Technical Challenges

Manufacturing Optimization and Process Intensification: Predictive Models and Product

Lifecycle Management

Analytical Strategies for Complex Therapeutics

9:30-10:30 Welcome Breakfast Presentation Sponsored by: Pall Life Sciences

10:30-12:00Integrated Continuous Processing

for Cell Culture Sponsored by Pall Life Sciences

Future Technologies and Their Impact on Downstream Processing Drug Product-Fill Finish Technologies

New Paradigms in Manufacturing Facilities and Technologies

Sponsored by: GE Healthcare

Analytical Testing Strategies and Analytical Control Two-Day Training Courses

12:05-12:35 Technology Workshops Sponsored by: BIASeparations, DNA 2.0, MaxCyte, GE Healthcare

12:40-1:40 Luncheon Presentations Sponsored by: MilliporeSigma, Roche, Sartorius Stedim Biotech

1:50-2:55 Improving Cell Line Development

with Novel Technologies Evolution in mAb Process Platforms Drug Product Strategies for Preifilled Syringes and Devices Best Practices for Leachables Testing and Microbial Monitoring Two-Day Training Courses

3:00-4:30 Keynote Presentations

4:30-6:30 Opening Night “Celebration of Science” Reception in the Exposition Hall Co-Sponsored by: KNect 365 & Lonza

7:00-9:30 Women’s Executive Leadership Dinner

7:00-9:00 2016 BioProcess International Awards Gala Dinner and Ceremony

Thursday, October 6, 2016 • Main Conference Exposition Hall Hours: 9:15 am-6:00 pmCell Culture &

Upstream Processing Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation

& QualityEarly Stage Biologics

& Companies7:30-8:00 Technology Workshop with Light Continental Breakfast Sponsored by: Repligen

8:10-9:15 Integration of Analytical Methodologies

and TechnologiesStreamlining Transfers & Progression from

Bench to Bedside Drug Product Strategies for BiologicsHarmonization of Manufacturing Strategies Regarding Human Performance and Room

Classification/GowningIntegration of Analytical Methodologies and

TechnologiesAccelerating Development of

Early Stage Programs

9:30 - 10:15 Keynote Presentation

11:00-12:30Cell Culture Acceleration

& Optimization Platforms and Novel Approaches

for Biotherapeutics Sponsored by Bio-Rad Laboratories

Primary Packaging Components and Container Closure

Open Forum: Industry-Academia Collaboration on Translation Research and

BiomanufacturingOpen Forum: CMC Dossiers

for Biotech ProductsAccelerating Development of


12:35-1:05 Technology Workshops Sponsored by: Irvine Scientific, Vironova, Entegris, GE Healthcare

1:05-2:25 Networking Luncheon in the Exposition Hall

2:25-4:00Improving Process Understanding,

Control, and Productivity at Clinical and Commercial Scale

Evolution in mAb Process PlatformsDrug Product Case Studies:

Residual Moisture, ADCs and Freeze Dryer Characterization

Manufacturing for Late Stage Development and Commercial Products Sponsored by Fujifilm

Diosynth BiotechnologiesQuality Risk Assessment and

QC Testing StrategiesFunding Strategies for Early Stage Companies

4:00-5:00 Networking Refreshment Break in the Exposition Hall

5:00-6:00Novel Single-Use Applications

in Cell Culture Sponsored by Sartorius Stedim Biotech

Streamlining Transfers & Progression from Bench to Bedside STAT Panel Discussion - Health and the Election: The Implications of Promises and Policy on Pricing and other Issues that Matter

6:00-10:00 Party In the Park

Friday, October 7, 2016 • Main Conference Exposition Hall Hours: 9:15 am-2:30 pm

Cell Culture & Upstream Processing Recovery & Purification Drug Product Manufacturing

& Fill-Finish Processing Manufacturing Strategy Analytical, Formulation & Quality

7:15-7:45 Technology Workshop with Light Continental Breakfast Sponsored by: GE Healthcare

8:05-12:30Development and Production

of New Modalities Innovations in High-Throughput

Development & Process ModelingCase Studies: Visual Particles, Process

Characterization and Scale-upFlexible Designs and Considerations for New

and Aging Manufacturing Facilities Formulation Strategies for Biologics

9:15-10:15 Plenary Keynote Speaker

12:35-1:05 Technology Workshops Sponsored by: GE Healthcare

1:05-2:25 Networking Luncheon & Last Chance for Poster Viewing in the Exposition Hall

2:25-4:30 Impact of Process Conditions

on Product Quality Process Automation, Integration &

IntensificationDrug Product and Fill-Finish Strategies for

Cell Therapy Products

Strategies to Control Raw Material Variability and to Improve Supply Chain Transparency

and Security Sponsored by: Avantor Performance Materials

Analytical Strategies for Biosimilars and Glycan Profiling

For up-to-date program information and new abstracts, visit: www.BPIevent.com

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TWO-DAY TRAINING COURSES • TUESDAY-WEDNESDAY, OCTOBER 4-5, 2016 • 9:00AM-5:00PM

CMC Analytical, Comparability and Stability Studies Introduction to Biopharmaceutical Manufacturing

This course provides a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability, release and stability of biotechnology products from the preclinical phase through clinical trials to commercialization and post-approval. Analytical considerations for a wide variety of biopharmaceuticals are discussed, including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates). Details are presented on establishing and maintaining product reference standards, designing successful comparability tests (including specifics for biosimilar studies), setting meaningful product specifications, conducting forced degradation studies, technology transfer and bridging changes in analytical methods and generating effective stability protocols. Critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through cGMP are illustrated.

Course Instructor:

Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

This course provides a fundamental understanding of biopharmaceutical manufacturing. Organized along the development path, the course will describe the activities necessary to bring a biopharmaceutical from discovery to market. Included in the course will be the analytical, quality and regulatory challenges as well as the technical activities required. The instructors will discuss how development activities integrate and the best practices for drug substance and drug product production. At the conclusion of the course the attendee will have learned the steps needed to develop and produce a safe and effective biopharmaceutical that meets industry and patient needs. Identified during the course will be how to implement QbD in development and communicating with regulatory agencies throughout development.

Course Instructors:

Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants

Frank Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants

Register Early for Best Savings • www.BPIevent.com • 800-390-4078

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Cell-Based Immunotherapies – From Concept to Commercialization Continuous Processing

On Time and within Budget: Successful Program Management of Biologics Development – Tools,

Techniques and Lessons Learned

Overview:to come

Sponsored by Overview:to come

Overview: Strong Program Management is critical to the successful completion of biologics programs. This workshop presents proven tools and methodologies while focusing on the idiosyncrasies of biotechnology. We will review the integration and management of R&D, CMC, preclinical and clinical programs from discovery to licensure/commercial launch. We will address partner and supplier management (CMOs, CROs…) as well as the securing and management of program funding (government and private equity).

Topics to be Covered:• Biologics Program Management• Shrinking development timelines• Cross functional integration• Working within smaller budgets• Becoming more virtual through partnering and subcontracting• Integrating biotechnology activities and organizations• CMO management• CRO management• Securing dilutive and non-dilutive funding

Speakers:Peter Latham, President and Managing Partner, Latham BioPharm Group, Inc., PgMPJoshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc., PMPGretchen Stup, Senior Consultant, Latham BioPharm Group, Inc., PMP

TUESDAY, OCTOBER 4, 2016 • PRE-CONFERENCE SYMPOSIA • 9:00am-5:00pm8:00 Registration and Coffee

Tuesday, October 4 • 7:30pm-10:30pm Catch the shuttle outside the BCEC for the BPI “BioBrew” Networking Event @ Harpoon Brewery (limited capacity; registration required)

BPI"BIOBREW"

EVENTSponsored by

and

Tuesday, October 4 Sartorius will be hosting a Site Tour to the UniQure Facility in Lexington, MA Buses will leave the Boston Convention & Exhibition Center at 1:00pm and will return at 6:00pm.(limited capacity; registration required)

SITE TOUR TO UNIQURE Sponsored by


Schedule Subject to Change7

TUESDAY, OCTOBER 4, 2016 • PRE-CONFERENCE SYMPOSIA • 9:00am-5:00pm

Modern CMC Regulatory Strategies and Insights - from Concept to Approval

Overview:On average, it still takes in excess of 10 years to develop a new biopharmaceutical drug product. It is estimated that the cost of developing a new biopharmaceutical drug product, and taking into account the > 90% failure rate, is over $2 billion. Conscious of this, the modern viewpoint is looking at ways in which to reduce this overall time and cost element. One strategy is to impart an approach of ‘accelerated development’ which, if done sensibly, can present an attractive and viable option. Quality focused planning, e.g. facilitated by quality by design, can also be used to potentially ‘shave off’ time to approval, whilst maintaining all important quality and regulatory maneuverability. Although faster development is attractive, regulatory aspects, particularly regulatory CMC also needs to keep up pace - which presents a number of difficult challenges. Pinch points:

• Sometimes it may become necessary to ‘challenge the norm’ and push back on certain regulations, within valid reason.

• FDA Breakthrough Therapy designation and EMA Priority Medicines (PRIME) designation provide an automatic ticket to enter the ‘fast lane’ - so welcome to the reality!

• Above all it is still important to have a well authored and ‘watertight’ regulatory dossier by which the competent authority will review the drug product in order to issue final marketing approval.

This session provides an overview of modern regulatory CMC strategies which may be selectively applied for a cross range of product classes (e.g. biopharmaceuticals, biologics, advanced therapy medicinal products, biosimilars, vaccines) and how this can be used in consideration for objectively reducing the overall time and cost. This ‘interactive’ session will focus on biopharmaceuticals, biologics, ATMPs, vaccines and biosimilars. Collective team discussions, whiteboard exemplification and work-throughs will be made on key topic points.

Topics to be Covered:

• Understanding of ‘the nature of the challenge’: from concept to authorization

• Modern mindsets: Technically driven approaches: ‘accelerated development’ pros and cons

• Be ready to ‘fast-track’- Breakthrough Therapy designation & Priority Medicines (PRIME); accelerated approval; ‘rolling’ submissions

• Exploration of the lifecycle of the investigational and final dossier:

• Breakdown of Timelines: Important Milestones

• High level dissection of CTD module 3: IND/IMPD – BLA/MAA - essential content and structuring

• The bridge between US and EU - important considerations

• Navigation of the essential guidelines and building blocks: biopharmaceuticals, biologics, ATMPs, vaccines, biosimilars; objective strategies of each

• Using Quality by Design to your best advantage

• Rest of World (RoW) CMC / regulatory considerations.

• Case Study of common issues: regulatory CMC

Speaker: Richard Dennett, Ph.D., Director, Voisin Consulting Life Sciences

8:00 Registration and Coffee

Supply Chain Security and Transparency from Starting Materials to Patient

Symposium Moderator and Opening Remarks

Introduction to Rx-360 and our Patient-Centric WorkMark Paxton, CEO, Rx-360 International Pharmaceutical Supply Chain Consortium

Morning Session: Why Upstream Quality MattersSupply Chain Mapping: Better Do it!Rob Welsh, Vice President, Bioprocessing Segment Solutions, VWR and Rx-360 International Pharmaceutical Supply Chain; Consortium Board Member & Co-Chair of Supply Chain Security Steering Committee

Rx-360 Response to Supplier QualificationBen Mills, Pharmaceutical Technical Lead, British Standards Institution

What We Expect of SuppliersLucy Cabral, Head, Supplier Quality Management, Genentech, Inc.

Why Standardizing Quality Agreements and Supplier Assessment Questionnaires is ImportantRick Calabrese, Global Director of Corporate Quality Systems, Sartorius Stedim North America

Afternoon Session: Who are Your Trading Partners and Why?Why Managing a Global Problem Cannot Be Solved LocallyBrian Johnson, Senior Director Supply Chain Security, Pfizer, Inc.

Amgen Efforts to Resolve Global RequirementsTim Valko, Executive Director, US Supply Chain, Amgen, Inc.

Compliance with Good Distribution Practices: How Many Standards?David Ulrich, QA Director - Supply Chain, Abbvie

Where is the Last Mile, and Why Do We Care?David Bang, CEO LifeConEx, DHL Global Forwarding

Cargo Thefts: Oh Yeah, They Occur! Brad Elrod, Director, Global Conveyance Security, Pfizer Pharmaceuticals


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WEDNESDAY, OCTOBER 5, 2016

Cell Culture & Upstream Processing Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation and Quality

7:00 Registration and Coffee 7:00 Registration and Coffee7:55 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks

Kevin Maloney, Ph.D., Principal Scientist, Technical Development, Biogen7:55 Chairperson’s Remarks

TBA, GE Healthcare Life SciencesChairperson’s RemarksMing Lei, Senior Research Associate, Protein Analytical Chemistry, Genentech

Optimizing the Transition into Early Stage Development

Innovation at the Interface of Upstream and Downstream Processing

Drug Product-Fill Finish Case Studies and Technical Challenges


Lifecycle ManagementAnalytical Strategies for Complex Therapeutics

8:00 FEATURED PRESENTATION: Optimizing Transition Points for Multiple Modalities - Thinking Beyond mAbsMartin J. Allen, Ph.D., Senior Director, BioProcess Research & Development, Pfizer

Across the Great Divide: The Upstream Origins and Downstream Ramifications of a Newly Discovered Contaminant ClassPeter Gagnon, Vice President, Peregrine Pharmaceuticals Inc.

Challenges from Drug Substance to Drug Product, A Case Study on Resolving Solubility and Stability Issues of a Tough Protein MoleculeWeiqiang Cheng, Ph.D., Senior Scientist, Drug & Combination Product Development, Shire

8:00 DOE and Predictive Modeling to Improve Decisions on the Manufacturing FloorMartin Kane, Managing Data Scientist, Exponent

Analytical Assay Design and Automation for CAR T-cell TherapyJunxia Wang, M.D., Ph.D., Fellow, TRD Process Analytical Design, Cell and Gene Therapies Unit, Novartis

8:30 Early Risk and Developability Assessment ApproachesSheri Nidositko, Ph.D., Fellow/Lab Head, Cell Line Development and Protein Production, Integrated Biologics Profiling, Novartis

Comprehensive Study of Different Harvest Technologies Under Several Biological Systems Juan Lagos, Senior Scientist, Upstream Process Development, Patheon Biologics

Lyophilization Cycle Tech Transfer – Strategies to Ensure SuccessDan Dixon, Senior Manager, Technical Services, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

8:30 The Use of Predictive Models to Transform Drug Product Development Paradigms – A Case Study on Drug Product MixingSuresh Nulu, Senior Engineer II, Parenteral Process Development, Biogen

Use of Slope Measurement for Increased Throughput of Concentration Determination of Antibody-drug Conjugates (ADCs)Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

9:00 Optimizing Molecule Assessment for Multiple Modalities Kristi Daris, Senior Scientist, Drug Substance PD, Amgen

Development of a Cell Recovery Process using Fluidized Bed CentrifugeRavinder Bhatia, MSc., Scientific Director, PDMS, Janssen R&D

Drug Product Manufacturing Challenges Due to Dissolved Gas in Drug Substance & MitigationSuresh Choudhary, Associate Scientist, Formulation Sciences, MedImmune LLC

9:00 Maximizing the Value of Commercial Scale Data: A Case Study Tom Mistretta, Principal Engineer, Process Development, Amgen, Inc.

Analytical Characterization of ADCs Conjugated Through LysinesHongling Han, Ph.D., Principal Scientist, Integrated Biologics Profiling, Novartis

9:30Welcome Breakfast Presentation Sponsored by: (See right hand panel)


Integrated Continuous Processing for Cell Culture



Sponsored by: Analytical Testing Strategies and

Analytical Control

10:30 Scaling-Up Integrated Continuous Bioprocesses for Commercialization Neha Shah, Ph.D., Senior Scientist, Commercial Process Development, Genzyme, A Sanofi Company

Single-Use Primary Capture Technology with the Promise to Deliver New Standards for the Economics, Convenience and Reliability of mAb BioprocessingOliver Hardick, Ph.D., CEO, Puridify Ltd., United Kingdom

Wireless Automated Glove Integrity Tester (WAGIT) for Isolator Technology Zach Price, Filling Engineer, Genentech, A Member of the Roche Group

10:30 Accelerating Bioproduction: From Plan to Plant in 18 Months in ChinaGE Healthcare Life Sciences Speaker TBA

Development of a UHPLC Peptide Map for a Commercial Control System and Its Application to Crosslink IdentificationMing Lei, Senior Research Associate, Protein Analytical Chemistry, Genentech

11:00 Hi-Intensity Upstream Processes enabling an Integrated Continuous Bioprocess Matthew Gagnon, B.Eng, Senior Scientist, BioProcess Research & Development, Pfizer, Inc.

Process Development for the Enzyme- Mediated Manufacture of a Site-Specific ADC for Early Clinical TrialsBirte Nolting, Ph.D., Senior Principal Scientist, Biotherapeutics Research and Development, Conjugation and Polytides Process Development, Pfizer

Stability Test Work to Show Vaccine Compatibility with Aseptic Blow/Fill/Seal TechnologyTim Kram, General Manager, rommelag USA, Inc. Otto Schubert, General Manager, Maropack AG, Switzerland

11:00 A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG Bert Frohlich, Ph.D., Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, ShireThomas Ryll, Ph.D., Vice President, Process and Analytical Development, Immunogen

Innovative Methods in Quantitating Host Residual DNA in Biologic DrugsMusaddeq Hussain, Ph.D., Principal Scientist, BioProcess Development, Merck Research Laboratories

11:30 End-to-End Integrated Continuous BioProcessing Platform for Biologics Manufacturing Engin Ayturk, Ph.D., R&D Manager, BioPharm Applications R&D, Pall Corporation

Hybrid Filters: An alternative to Chromatography?Nripen Singh, Ph.D., Senior Scientist, Biologics Development Organization (BDO), Bristol Myers Squibb

Controlled Nucleation for Lyophilization – Ensuring Robustness of Nucleation through a Mechanistic Understanding of the TechnologyJacob Luoma, Engineer 1, Pharmaceutical Processing and Technology Development, Genentech, A Member of the Roche Group

11:30 Footprinting our Drugs: Biologics Process Mass Intensity ToolBonnie Shum, Engineer, Global Biologics Manufacturing Sciences and Technology, Genentech, Inc., A Member of the Roche Group

An Automated High Throughput AlphaLISA Assay for Host Cell Protein Quantitation in Early Stage ScreeningZhichao Fang, Ph.D., Scientist, Process Development, Bristol-Myers Squibb

12:05 Technology Workshops (See right hand panel) 12:05 Technology Workshops (See right hand panel)

12:40 Luncheon Presentations (See right hand panel) 12:40 Luncheon Presentations (See right hand panel)


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WEDNESDAY, OCTOBER 5, 20169:30 Welcome Breakfast Presentation

Pall Biopharmaceuticals' Leader Provides an Update on Significant Technology Advances Enabling Integrated Continuous BioProcessing Michael Egholm, VP and General Manager, Pall Pharmaceuticals

12:15 Technology WorkshopsTBA Speaker TBA

A Systematic Approach to Engineering Antibody Expression Kate Caves, MSc., Principle Scientist and Director of Business Development, DNA2.0

Faster to Market: Speeding Up Your Cell Culture Media Development Speaker TBA

TBA TBA

1:10 Luncheon Presentations

Fast Track to Your Qbd Approach – Integrated Bioreactor, Sensor an Software Platform to Accelerate Antibody DevelopmentDr. Christel Fenge, VP Marketing and Product Management Fermentation Technologies, Sartorius Stedim Biotech GmbH

TBA TBA TBA

Experiences Automating the Roche Cedex BioHT and HiRes with the Flownamics SegFlow On-line Sampling System Kristin O’Neill, Associate Principal Scientist, MerckAnkit Mehta, Scientist, Merck

Cell Culture & Upstream Processing Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation and Quality

7:00 Registration and Coffee 7:00 Registration and Coffee7:55 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s Remarks

Kevin Maloney, Ph.D., Principal Scientist, Technical Development, Biogen7:55 Chairperson’s Remarks

TBA, GE Healthcare Life SciencesChairperson’s RemarksMing Lei, Senior Research Associate, Protein Analytical Chemistry, Genentech

Optimizing the Transition into Early Stage Development

Innovation at the Interface of Upstream and Downstream Processing

Drug Product-Fill Finish Case Studies and Technical Challenges


Lifecycle ManagementAnalytical Strategies for Complex Therapeutics

8:00 FEATURED PRESENTATION: Optimizing Transition Points for Multiple Modalities - Thinking Beyond mAbsMartin J. Allen, Ph.D., Senior Director, BioProcess Research & Development, Pfizer

Across the Great Divide: The Upstream Origins and Downstream Ramifications of a Newly Discovered Contaminant ClassPeter Gagnon, Vice President, Peregrine Pharmaceuticals Inc.

Challenges from Drug Substance to Drug Product, A Case Study on Resolving Solubility and Stability Issues of a Tough Protein MoleculeWeiqiang Cheng, Ph.D., Senior Scientist, Drug & Combination Product Development, Shire

8:00 DOE and Predictive Modeling to Improve Decisions on the Manufacturing FloorMartin Kane, Managing Data Scientist, Exponent

Analytical Assay Design and Automation for CAR T-cell TherapyJunxia Wang, M.D., Ph.D., Fellow, TRD Process Analytical Design, Cell and Gene Therapies Unit, Novartis

8:30 Early Risk and Developability Assessment ApproachesSheri Nidositko, Ph.D., Fellow/Lab Head, Cell Line Development and Protein Production, Integrated Biologics Profiling, Novartis

Comprehensive Study of Different Harvest Technologies Under Several Biological Systems Juan Lagos, Senior Scientist, Upstream Process Development, Patheon Biologics

Lyophilization Cycle Tech Transfer – Strategies to Ensure SuccessDan Dixon, Senior Manager, Technical Services, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

8:30 The Use of Predictive Models to Transform Drug Product Development Paradigms – A Case Study on Drug Product MixingSuresh Nulu, Senior Engineer II, Parenteral Process Development, Biogen

Use of Slope Measurement for Increased Throughput of Concentration Determination of Antibody-drug Conjugates (ADCs)Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

9:00 Optimizing Molecule Assessment for Multiple Modalities Kristi Daris, Senior Scientist, Drug Substance PD, Amgen

Development of a Cell Recovery Process using Fluidized Bed CentrifugeRavinder Bhatia, MSc., Scientific Director, PDMS, Janssen R&D

Drug Product Manufacturing Challenges Due to Dissolved Gas in Drug Substance & MitigationSuresh Choudhary, Associate Scientist, Formulation Sciences, MedImmune LLC

9:00 Maximizing the Value of Commercial Scale Data: A Case Study Tom Mistretta, Principal Engineer, Process Development, Amgen, Inc.

Analytical Characterization of ADCs Conjugated Through LysinesHongling Han, Ph.D., Principal Scientist, Integrated Biologics Profiling, Novartis



Integrated Continuous Processing for Cell Culture



Sponsored by: Analytical Testing Strategies and

Analytical Control

10:30 Scaling-Up Integrated Continuous Bioprocesses for Commercialization Neha Shah, Ph.D., Senior Scientist, Commercial Process Development, Genzyme, A Sanofi Company

Single-Use Primary Capture Technology with the Promise to Deliver New Standards for the Economics, Convenience and Reliability of mAb BioprocessingOliver Hardick, Ph.D., CEO, Puridify Ltd., United Kingdom

Wireless Automated Glove Integrity Tester (WAGIT) for Isolator Technology Zach Price, Filling Engineer, Genentech, A Member of the Roche Group

10:30 Accelerating Bioproduction: From Plan to Plant in 18 Months in ChinaGE Healthcare Life Sciences Speaker TBA

Development of a UHPLC Peptide Map for a Commercial Control System and Its Application to Crosslink IdentificationMing Lei, Senior Research Associate, Protein Analytical Chemistry, Genentech

11:00 Hi-Intensity Upstream Processes enabling an Integrated Continuous Bioprocess Matthew Gagnon, B.Eng, Senior Scientist, BioProcess Research & Development, Pfizer, Inc.

Process Development for the Enzyme- Mediated Manufacture of a Site-Specific ADC for Early Clinical TrialsBirte Nolting, Ph.D., Senior Principal Scientist, Biotherapeutics Research and Development, Conjugation and Polytides Process Development, Pfizer

Stability Test Work to Show Vaccine Compatibility with Aseptic Blow/Fill/Seal TechnologyTim Kram, General Manager, rommelag USA, Inc. Otto Schubert, General Manager, Maropack AG, Switzerland

11:00 A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG Bert Frohlich, Ph.D., Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, ShireThomas Ryll, Ph.D., Vice President, Process and Analytical Development, Immunogen

Innovative Methods in Quantitating Host Residual DNA in Biologic DrugsMusaddeq Hussain, Ph.D., Principal Scientist, BioProcess Development, Merck Research Laboratories

11:30 End-to-End Integrated Continuous BioProcessing Platform for Biologics Manufacturing Engin Ayturk, Ph.D., R&D Manager, BioPharm Applications R&D, Pall Corporation

Hybrid Filters: An alternative to Chromatography?Nripen Singh, Ph.D., Senior Scientist, Biologics Development Organization (BDO), Bristol Myers Squibb

Controlled Nucleation for Lyophilization – Ensuring Robustness of Nucleation through a Mechanistic Understanding of the TechnologyJacob Luoma, Engineer 1, Pharmaceutical Processing and Technology Development, Genentech, A Member of the Roche Group

11:30 Footprinting our Drugs: Biologics Process Mass Intensity ToolBonnie Shum, Engineer, Global Biologics Manufacturing Sciences and Technology, Genentech, Inc., A Member of the Roche Group

An Automated High Throughput AlphaLISA Assay for Host Cell Protein Quantitation in Early Stage ScreeningZhichao Fang, Ph.D., Scientist, Process Development, Bristol-Myers Squibb


12:40 Luncheon Presentations (See right hand panel) 12:40 Luncheon Presentations (See right hand panel)


10

WEDNESDAY, OCTOBER 5, 2016 (CONTINUED)

Cell Culture Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation and Quality

1:50 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksKevin Maloney, Ph.D., Principal Scientist, Technical Development, Biogen

1:50 Chairperson’s RemarksMiriam Monge, Director of Process Development & Bioprocess & Bioprocess Platform Marketing Team, Integrated Solutions, Sartorius Stedim FMT S.A.S, France

Improving Cell Line Development with Novel Technologies Evolution in mAb Process Platforms Drug Product Strategies for Pre-filled Syringes

and Devices Best Practices for Leachables Testing and Microbial Monitoring

1:55 Novel Technologies to Characterize Clone Productivity Tanner Nevill, Ph.D., Director, Product Applications, Biopharma, Berkeley Lights, Inc.

Development of an Acidic/Neutral Antibody Flow-Through Polishing Step Using Salt-Tolerant Anion-Exchange Chromatography Rajesh Ambat, M.S., Principal Associate, Process Development - Downstream, Eli Lilly

Integrating Drug & Device Development for Best-in-class Patient Treatment ExperienceDidier Pertuy, Vice President, Global Head Drug-Device Integrated Development, Sanofi, France

1:55 BPOG Leachables Best Practice Testing Guide for IndustryPing Wang, Ph.D., Principal Scientist, Materials Sciences, Pharmaceutical Development and Manufacturing Sciences, Janssen Research & Development Seamus O'Connor, Associate Manager, Analytical Sciences, Regeneron Pharmaceuticals, Inc.

2:25 Application of Gene editing Technologies for Development of Cell Lines Kevin J. Kaiser, Ph.D., Senior Director, R&D, MilliporeSigma

Platforms for Continuous Processing Natraj Ram, Ph.D., Associate Director, Purification, Manufacturing Sciences, AbbVie Inc.

Component Selection Strategies for PFS- Risk Mitigation, Performance, and Injection Volume Driving Innovative SolutionsAndrea Straka, Supervisor, Project Management, West Pharmaceutical Services

2:25 Microbial Monitoring for Biological Drug Substance - An Industry PerspectiveBrian L. Bell, Ph.D., Manager, Process Microbiology, Process Lifecycle Management, Manufacturing Science & Technology, Bristol-Myers Squibb

Keynote Presentations Keynote Presentations3:00 Chairperson’s Remarks 3:00 Chairperson’s Remarks

3:10

Engineering Aspects and Practical Experience from Amgen’s Singapore Next Generation Manufacturing FacilityThis presentation will discuss our experiences with the design and operation of Amgen’s Next Generation Manufacturing facility in Singapore. An emphasis on engineering aspects and lessons learned from operating the plant will be presented. Matthew Shields, Executive Director and Plant Manager, Amgen Singapore Manufacturing, Singapore

3:10


3:50The Success and Future of ADCsADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the elements in their design, from target selection, selection of the antibody, the cytotoxic “payload”, and the linker, are important. These elements will be illustrated with examples from ImmunoGen’s clinical pipeline, and with examples from the newest developments in payload-linker chemistry in preclinical research.John M. Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, Inc.

3:50 The Success and Future of ADCsADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the elements in their design, from target selection, selection of the antibody, the cytotoxic “payload”, and the linker, are important. These elements will be illustrated with examples from ImmunoGen’s clinical pipeline, and with examples from the newest developments in payload-linker chemistry in preclinical research.John M. Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, In

4:30Opening Night “Celebration of Science” Reception in the Exposition Hall co-sponsored by

and

4:30

Opening Night “Celebration of Science” Reception in the Exposition Hall co-sponsored by and

7:00 Women’s Executive Leadership Dinner 7:00 Women’s Executive Leadership Dinner

7:00 2016 BioProcess International Awards Gala Dinner and Ceremony 7:00 2016 BioProcess International Awards Gala Dinner and Ceremony


11

WEDNESDAY, OCTOBER 5, 2016 (CONTINUED)


1:50 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksKevin Maloney, Ph.D., Principal Scientist, Technical Development, Biogen

1:50 Chairperson’s RemarksMiriam Monge, Director of Process Development & Bioprocess & Bioprocess Platform Marketing Team, Integrated Solutions, Sartorius Stedim FMT S.A.S, France

Improving Cell Line Development with Novel Technologies Evolution in mAb Process Platforms Drug Product Strategies for Pre-filled Syringes

and Devices Best Practices for Leachables Testing and Microbial Monitoring

1:55 Novel Technologies to Characterize Clone Productivity Tanner Nevill, Ph.D., Director, Product Applications, Biopharma, Berkeley Lights, Inc.

Development of an Acidic/Neutral Antibody Flow-Through Polishing Step Using Salt-Tolerant Anion-Exchange Chromatography Rajesh Ambat, M.S., Principal Associate, Process Development - Downstream, Eli Lilly

Integrating Drug & Device Development for Best-in-class Patient Treatment ExperienceDidier Pertuy, Vice President, Global Head Drug-Device Integrated Development, Sanofi, France

1:55 BPOG Leachables Best Practice Testing Guide for IndustryPing Wang, Ph.D., Principal Scientist, Materials Sciences, Pharmaceutical Development and Manufacturing Sciences, Janssen Research & Development Seamus O'Connor, Associate Manager, Analytical Sciences, Regeneron Pharmaceuticals, Inc.

2:25 Application of Gene editing Technologies for Development of Cell Lines Kevin J. Kaiser, Ph.D., Senior Director, R&D, MilliporeSigma

Platforms for Continuous Processing Natraj Ram, Ph.D., Associate Director, Purification, Manufacturing Sciences, AbbVie Inc.

Component Selection Strategies for PFS- Risk Mitigation, Performance, and Injection Volume Driving Innovative SolutionsAndrea Straka, Supervisor, Project Management, West Pharmaceutical Services

2:25 Microbial Monitoring for Biological Drug Substance - An Industry PerspectiveBrian L. Bell, Ph.D., Manager, Process Microbiology, Process Lifecycle Management, Manufacturing Science & Technology, Bristol-Myers Squibb

Keynote Presentations Keynote Presentations3:00 Chairperson’s Remarks 3:00 Chairperson’s Remarks

3:10


3:10


3:50The Success and Future of ADCsADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the elements in their design, from target selection, selection of the antibody, the cytotoxic “payload”, and the linker, are important. These elements will be illustrated with examples from ImmunoGen’s clinical pipeline, and with examples from the newest developments in payload-linker chemistry in preclinical research.John M. Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, Inc.

3:50 The Success and Future of ADCsADCs offer a strategy for developing anti-cancer drugs of great promise. In creating effective, well-tolerated, ADCs, each of the elements in their design, from target selection, selection of the antibody, the cytotoxic “payload”, and the linker, are important. These elements will be illustrated with examples from ImmunoGen’s clinical pipeline, and with examples from the newest developments in payload-linker chemistry in preclinical research.John M. Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, Research, ImmunoGen, In

4:30Opening Night “Celebration of Science” Reception in the Exposition Hall co-sponsored by

and

4:30

Opening Night “Celebration of Science” Reception in the Exposition Hall co-sponsored by and

7:00 Women’s Executive Leadership Dinner 7:00 Women’s Executive Leadership Dinner

7:00 2016 BioProcess International Awards Gala Dinner and Ceremony 7:00 2016 BioProcess International Awards Gala Dinner and Ceremony

OPENING NIGHT “CELEBRATION OF SCIENCE”

Reception In The Exposition HallWednesday, October 5 • 4:30 pm - 6:30 pm

Kick off your conference experience at the Opening Night Party to celebrate the launch of Biotech Week Boston! Explore our “Celebration of Science” theme with a taste of molecular gastronomy from Boston’s celebrity chefs. The party will feature “Dueling DJ’s”, from the theater zone while you catch up with colleagues and friends, network with attendees, exhibitors and sponsors. Participate in several interactive activities and/or relax in one of the themed lounge areas. Enjoy a fun evening with food, drinks and entertainment.


12

THURSDAY, OCTOBER 6, 2016

Cell Culture Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation

and QualityEarly Stage Biologics

and Companies7:00 Registration and Coffee 7:00 Registration and Coffee

7:30 Technology Workshop with Light Continental Breakfast (See right hand panel) 7:30 Technology Workshop with Light Continental Breakfast (See right hand panel)

8:10 Chairperson's Remarks Chairperson's RemarksMark A. Snyder, Ph.D., Manager, Applications R&D Group, Bio-Rad Laboratories

Chairperson's RemarksDevon Roshan Eisner, Engineer, Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group

Chairperson's RemarksKamal Rashid, Ph.D., Director, Biomanufacturing Education & Training Center and Research Professor of Biology/Biotechnology, Worcester Polytechnic Institute

8:10 Chairperson's RemarksNadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Chairperson's RemarksSusan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants

Integration of Analytical Methodologies and Technologies

Streamlining Transfers & Progression from Bench to Bedside

Drug Product Strategies for Biologics

Harmonization of Manufacturing Strategies Regarding Human

Performance and Room Classification/Gowning


Accelerating Development of Early Stage Programs

8:15 The Use of a Novel Single Cell Dielectrophoretic (DEP) Cytometer to Monitor Changes in CHO Cell Metabolism Michael Butler, Ph.D., Professor, Microbiology, University of Manitoba

Optimizing the Simultaneous Transfer of Two Drug Substance Production Processes to a Start-up Contract Manufacturing OrganizationAdam Myrold, MSc., Engineer II, Global Manufacturing Science and Technology, Genentech, Inc.

Biologics Drug Product Technology TransferArun Jangda, Lead - Drug Product External Manufacture, Drug & Combination Product Development, Shire

Changing the Performance Paradigm in BioPharma: Integrating Human Performance in Global OperationsAmy Wilson, Ph.D., Director, Performance Development,Global Biologics Manufacturing & Technical Operations, BiogenMichael Moedler, Ph.D., Head Error Prevention System, Lonza AG, Switzerland

8:15 The Use of a Novel Single Cell Dielectrophoretic (DEP) Cytometer to Monitor Changes in CHO Cell MetabolismMichael Butler, Ph.D., Professor, Microbiology, University of Manitoba

Improving Development Outcomes by Aligning Developability Assessment with OptimizationRobert Mabry, Ph.D., Director of Protein Sciences and Antibody Technology, Jounce Therapeutics

8:45 Advanced Analytical Methods to Measure Oxidative Stress Impact on Mammalian Cells Productivity and Product Quality Weimin Lin, Ph.D., Senior Scientist, Cell Culture Development, Biogen

Manufacturing gp120 Based Novel HIV Vaccine Candidates: Simultaneously Meeting Demands of Cost and Rapid Progression from Bench to BedsideAbhinav Shukla, Ph.D., Vice President, Development and Manufacturing, KBI Biopharma

Presentation Sponsorship OpportunityIf you have a drug product or fill-finish related case study or technology and are interested in sponsoring a presentation in this session, please contact Jennifer Wickett at [email protected] or Kristen Schott at [email protected]

Harmonization of Room Classification and Gowning Requirements across the Biopharmaceutical Manufacturing IndustryLars Hovmand-Lyster, M.D., Principal Scientist Recovery, Diabetes Active Pharmaceutical Ingredients, Novo Nordisk, Denmark

8:45 Advanced Analytical Methods to Measure Oxidative Stress Impact on Mammalian Cells Productivity and Product QualityWeimin Lin, Ph.D., Senior Scientist, Cell Culture Development, Biogen

Presentation Sponsorship OpportunityIf you have an early stage product or technology and are interested in sponsoring a presentation in this session, please contact Jennifer Wickett at [email protected] or Kristen Schott at [email protected]

Keynote Presentation Keynote Presentation9:30 Emerging Global Health Issues – Tackling Global Health through the Development of Vaccines, Drug and Diagnostics: How the Pharma/Bio Industry Can Help 9:30 Emerging Global Health Issues – Tackling Global Health through the Development of

Vaccines, Drug and Diagnostics: How the Pharma/Bio Industry Can Help

10:15 Networking Refreshment Break in Exposition Hall 10:15 Networking Refreshment Break in Exposition Hall


13

THURSDAY, OCTOBER 6, 2016



and Companies7:00 Registration and Coffee 7:00 Registration and Coffee


8:10 Chairperson's Remarks Chairperson's RemarksMark A. Snyder, Ph.D., Manager, Applications R&D Group, Bio-Rad Laboratories

Chairperson's RemarksDevon Roshan Eisner, Engineer, Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group

Chairperson's RemarksKamal Rashid, Ph.D., Director, Biomanufacturing Education & Training Center and Research Professor of Biology/Biotechnology, Worcester Polytechnic Institute

8:10 Chairperson's RemarksNadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Chairperson's RemarksSusan Dana Jones, Ph.D., Vice President and Principal Consultant, BioProcess Technology Consultants


Streamlining Transfers & Progression from Bench to Bedside

Drug Product Strategies for Biologics

Harmonization of Manufacturing Strategies Regarding Human

Performance and Room Classification/Gowning


Accelerating Development of Early Stage Programs

8:15 The Use of a Novel Single Cell Dielectrophoretic (DEP) Cytometer to Monitor Changes in CHO Cell Metabolism Michael Butler, Ph.D., Professor, Microbiology, University of Manitoba

Optimizing the Simultaneous Transfer of Two Drug Substance Production Processes to a Start-up Contract Manufacturing OrganizationAdam Myrold, MSc., Engineer II, Global Manufacturing Science and Technology, Genentech, Inc.

Biologics Drug Product Technology TransferArun Jangda, Lead - Drug Product External Manufacture, Drug & Combination Product Development, Shire

Changing the Performance Paradigm in BioPharma: Integrating Human Performance in Global OperationsAmy Wilson, Ph.D., Director, Performance Development,Global Biologics Manufacturing & Technical Operations, BiogenMichael Moedler, Ph.D., Head Error Prevention System, Lonza AG, Switzerland

8:15 The Use of a Novel Single Cell Dielectrophoretic (DEP) Cytometer to Monitor Changes in CHO Cell MetabolismMichael Butler, Ph.D., Professor, Microbiology, University of Manitoba

Improving Development Outcomes by Aligning Developability Assessment with OptimizationRobert Mabry, Ph.D., Director of Protein Sciences and Antibody Technology, Jounce Therapeutics

8:45 Advanced Analytical Methods to Measure Oxidative Stress Impact on Mammalian Cells Productivity and Product Quality Weimin Lin, Ph.D., Senior Scientist, Cell Culture Development, Biogen

Manufacturing gp120 Based Novel HIV Vaccine Candidates: Simultaneously Meeting Demands of Cost and Rapid Progression from Bench to BedsideAbhinav Shukla, Ph.D., Vice President, Development and Manufacturing, KBI Biopharma


Harmonization of Room Classification and Gowning Requirements across the Biopharmaceutical Manufacturing IndustryLars Hovmand-Lyster, M.D., Principal Scientist Recovery, Diabetes Active Pharmaceutical Ingredients, Novo Nordisk, Denmark

8:45 Advanced Analytical Methods to Measure Oxidative Stress Impact on Mammalian Cells Productivity and Product QualityWeimin Lin, Ph.D., Senior Scientist, Cell Culture Development, Biogen

Presentation Sponsorship OpportunityIf you have an early stage product or technology and are interested in sponsoring a presentation in this session, please contact Jennifer Wickett at [email protected] or Kristen Schott at [email protected]

Keynote Presentation Keynote Presentation9:30 Emerging Global Health Issues – Tackling Global Health through the Development of Vaccines, Drug and Diagnostics: How the Pharma/Bio Industry Can Help 9:30 Emerging Global Health Issues – Tackling Global Health through the Development of

Vaccines, Drug and Diagnostics: How the Pharma/Bio Industry Can Help

10:15 Networking Refreshment Break in Exposition Hall 10:15 Networking Refreshment Break in Exposition Hall

7:30 Technology Workshop with Light Continental Breakfast

Single-use XCell™ ATF Systems for continuous processing: 100% Cell retention, 8x Faster set-up, No autoclave Christine Gebski, Vice President, Product Management and Field Application, Repligen


a 14

THURSDAY, OCTOBER 6, 2016 (CONTINUED)



and Companies

Cell Culture Acceleration & Optimization

Platforms and Novel Approaches for Biotherapeutics

Sponsored by:


Open Forum: Industry-Academia Collaboration in Translational

Research and Biomanufacturing of Next-Generation Biologics

Open Forum: CMC Dossiers for Biotech Products: Substance

with StyleAccelerating Development of


11:00 Frozen Inoculum Approaches to Debottleneck Facility Capacity Shahid Rameez, Ph.D., Principal Scientist, Process Development, KBI Biopharma Inc.

Development of a Custom Resin for Purification of Fully Human Bispecific Antibodies and Implications for Continuous Processing Andrew Tustian, Eng.D., Associate Director, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc.

Hydrogen Peroxide Uptake in Primary Packaging Components Devon Roshan Eisner, Engineer, Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group

Moderator:Kamal Rashid, Ph.D., Director, Biomanufacturing Education & Training Center and Research Professor of Biology/Biotechnology, Worcester Polytechnic InstitutePanelists:Mark S. Klempner, M.D., Executive Vice Chancellor, Mass Biologics and Professor of Medicine, University of Massachusetts Medical SchoolSusan Roberts, Ph.D., Professor and Head, Chemical Engineering Department, Worcester Polytechnic InstituteStacy Springs, Ph.D., Director, Biomanufacturing Program, Executive Director, Consortium on Adventitious Agent Contamiånation in Biomanufacturing, MIT Center for Biomedical InnovationJerome Ritz, M.D., Executive Director, Connell O’Reilly Manipulation Core Facility and Professor of Medicine, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical SchoolDavid Dismuke, Ph.D., Director of Vector Production, Voyager Therapeutics Inc.

11:00 Moderator:Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Where Is It Written? ICH CTD Module 3!Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Pet Peeves and Roadblocks in CMC: Improving your Quality Submissions through the Product LifecycleMarjorie Shapiro, Ph.D., Chief, Laboratory of Molecular & Developmental Immunology, CDER, US FDA (Tentative)

Preparing Effective Module-3 – Challenges and Opportunities Roman Drews, Ph.D., Senior Director Regulatory Affairs, LFB USA and Former Regulatory Scientist/Team Lead, Office of Blood Review and Research, CBER, US FDA

Balanced mAb Process Development Strategy to Enable Pre-Clinical AccelerationShamik Sharma, Ph.D., Principal Scientist, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

11:30 Application of HIPDOG in AMBR System Paetrice Jones, M.S., Scientist, Pfizer

An Efficient Two-Column Platform for Recombinant Bacterial Antigen ProductionXuemei He, Ph.D., R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories

Case Study: Data on Liquid Shipping in Single-use Bags Supporting Biotech Process QualificationElisabeth Vachette, Senior Global Product Manager, Marketing, Sartorius Stedim FMT S.A.S., France

11:30 Accelerated and Cost Effective Development of a Novel Biologic in a Virtual Environment: A Better ParadigmLaurence Blumberg, M.D., Founder & Chief Operating Officer, Syntimmune, Inc.

12:00 Accelerated CHO-Cell Culture Perfusion Processes Using Novel Frozen Seed Bag (FSB) Nikhil Ramsubramaniam, Ph.D., Senior Scientist, Upstream Processing, Bioprocess Technology & Expression, Merck & Co.

Downstream Processing of a Large Live Virus: Challenges in Development and Scale up for a Sterile Purification ProcessAdam Kristopeit, Associate Principal Scientist, Vaccine Process Development, Merck & Co.

PANEL DISCUSSION: Challenges of Fill-Finish for Non-Standard and Emerging ModalitiesThomas Page, Ph.D., Vice President, Engineering, Fujifilm Diosynth Biotechnologies Texas Wayne Wilson, Ph.D., Vice President, Quality, Fujifilm Diosynth Biotechnologies Texas

12:00 Late Breaking Presentations


1:05 Networking Luncheon in the Exposition Hall 1:05 Networking Luncheon in the Exposition Hall


a 15




and Companies

Cell Culture Acceleration & Optimization

Platforms and Novel Approaches for Biotherapeutics

Sponsored by:


Open Forum: Industry-Academia Collaboration in Translational

Research and Biomanufacturing of Next-Generation Biologics

Open Forum: CMC Dossiers for Biotech Products: Substance

with StyleAccelerating Development of


11:00 Frozen Inoculum Approaches to Debottleneck Facility Capacity Shahid Rameez, Ph.D., Principal Scientist, Process Development, KBI Biopharma Inc.

Development of a Custom Resin for Purification of Fully Human Bispecific Antibodies and Implications for Continuous Processing Andrew Tustian, Eng.D., Associate Director, Preclinical Manufacturing and Process Development, Regeneron Pharmaceuticals, Inc.

Hydrogen Peroxide Uptake in Primary Packaging Components Devon Roshan Eisner, Engineer, Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group

Moderator:Kamal Rashid, Ph.D., Director, Biomanufacturing Education & Training Center and Research Professor of Biology/Biotechnology, Worcester Polytechnic InstitutePanelists:Mark S. Klempner, M.D., Executive Vice Chancellor, Mass Biologics and Professor of Medicine, University of Massachusetts Medical SchoolSusan Roberts, Ph.D., Professor and Head, Chemical Engineering Department, Worcester Polytechnic InstituteStacy Springs, Ph.D., Director, Biomanufacturing Program, Executive Director, Consortium on Adventitious Agent Contamiånation in Biomanufacturing, MIT Center for Biomedical InnovationJerome Ritz, M.D., Executive Director, Connell O’Reilly Manipulation Core Facility and Professor of Medicine, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Harvard Medical SchoolDavid Dismuke, Ph.D., Director of Vector Production, Voyager Therapeutics Inc.

11:00 Moderator:Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Where Is It Written? ICH CTD Module 3!Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Pet Peeves and Roadblocks in CMC: Improving your Quality Submissions through the Product LifecycleMarjorie Shapiro, Ph.D., Chief, Laboratory of Molecular & Developmental Immunology, CDER, US FDA (Tentative)

Preparing Effective Module-3 – Challenges and Opportunities Roman Drews, Ph.D., Senior Director Regulatory Affairs, LFB USA and Former Regulatory Scientist/Team Lead, Office of Blood Review and Research, CBER, US FDA

Balanced mAb Process Development Strategy to Enable Pre-Clinical AccelerationShamik Sharma, Ph.D., Principal Scientist, Bioprocess R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

11:30 Application of HIPDOG in AMBR System Paetrice Jones, M.S., Scientist, Pfizer

An Efficient Two-Column Platform for Recombinant Bacterial Antigen ProductionXuemei He, Ph.D., R&D Manager, Chromatography Media Chemistry, Bio-Rad Laboratories

Case Study: Data on Liquid Shipping in Single-use Bags Supporting Biotech Process QualificationElisabeth Vachette, Senior Global Product Manager, Marketing, Sartorius Stedim FMT S.A.S., France

11:30 Accelerated and Cost Effective Development of a Novel Biologic in a Virtual Environment: A Better ParadigmLaurence Blumberg, M.D., Founder & Chief Operating Officer, Syntimmune, Inc.

12:00 Accelerated CHO-Cell Culture Perfusion Processes Using Novel Frozen Seed Bag (FSB) Nikhil Ramsubramaniam, Ph.D., Senior Scientist, Upstream Processing, Bioprocess Technology & Expression, Merck & Co.

Downstream Processing of a Large Live Virus: Challenges in Development and Scale up for a Sterile Purification ProcessAdam Kristopeit, Associate Principal Scientist, Vaccine Process Development, Merck & Co.

PANEL DISCUSSION: Challenges of Fill-Finish for Non-Standard and Emerging ModalitiesThomas Page, Ph.D., Vice President, Engineering, Fujifilm Diosynth Biotechnologies Texas Wayne Wilson, Ph.D., Vice President, Quality, Fujifilm Diosynth Biotechnologies Texas

12:00 Late Breaking Presentations


1:05 Networking Luncheon in the Exposition Hall 1:05 Networking Luncheon in the Exposition Hall

12:15 Technology Workshops

Advanced Materials for Single Use SystemsJayanthi Grebin, Product Manager – Life Sciences, Entegris Inc

When, Why and How to Outsource BiomanufacturingTBA

An Integrated BalanCD® CHO Media Solution for Early Therapeutic Antibody Development, Scale-Up and Commercial Supply Jessie Ni, Ph.D, CSO, Irvine Scientific Yves Durocher, Ph.D, Research Office, National Research Council Canada

Reveal information that Gives Insights – New Approaches to Sub-Visible Particle CharacterizationDr. Josefina Nilsson, Head of EM services, Vironova ABDr. Gustaf Kyhlberg, Ph.D., Product Manager MiniTEM, Vironova AB


16


Cell Culture Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation and Quality Early Stage Biologics and Companies

2:25 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksMark Yang, Ph.D., Director of Fill Finish Development, Sanofi Genzyme

2:25 Chairperson’s RemarksTBA, FUJIFILM Diosynth Biotechnologies

Chairperson’s RemarksMelissa Morandi, Vice President, Global Quality, Aegerion Pharmaceuticals

Chairperson’s RemarksJoshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc.

Improving Process Understanding, Control, and Productivity at Clinical and Commercial Scale Featured Presentation Drug Product Case Studies: Residual Moisture,

ADCs and Freeze Dryer CharacterizationManufacturing for Late Stage Development and

Commercial Products Sponsored by:

Quality Risk Assessment and QC Testing Strategies Funding Strategies for Early Stage Companies

2:30 Developing Robust Control Strategies for Sustainable Upstream Commercial Manufacturing Kartik Subramanian, Ph.D., Principal Scientist and Group Leader, Manufacturing Sciences, AbbVie

Presentation Title TBDGünter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, BioProcess Division, Sweden

Case Study: Residual Moisture in Lyophilized Drug Product, How Much Is Too Much? Mark Yang, Ph.D., Director of Fill Finish Development, Sanofi Genzyme

2:30 Bioreactor Process Improvements in a Legacy Perfusion-based Process Jiayi Zhang, Ph.D., Manager Process Engineering Development, MSAT, Genzyme

Risk Assessment across the Entire Quality System and CompanyMelissa Morandi, Vice President, Global Quality, Aegerion Pharmaceuticals

Funding a Therapeutic-Focused Company through Angels: The Good, The Bad and the UglyBarbara Fox, Ph.D., Entrepreneur-in-Residence, Partners Innovation Fund and Former CEO, Avaxia Biologics

Novel Chromatographic Selectivities & Innovative Materials for Next Generation

Purification3:00 Optimization of Productivity and Targeted

Modulation of Product Quality Attributes of a Phase III IgG Utilizing the Ambr15 PlatformMichael A. Bennett, MSc., Scientist, Process Development, Patheon

Performance of Next Generation High Capacity Anion Exchange Media in mAb Purification Debola Banerjee, M.Tech, Engineer II, Purification Development, Genentech, Inc.

Evaluation of Quality Attributes of an Antibody-Drug Conjugate (ADC 1) Following Extended Storage in a Stainless Steel ContainerAmy Leung, Scientist I, ImmunoGen, Inc.

3:00 Manufacturing for Late Phase DevelopmentSpeaker TBA, FUJIFILM Diosynth Biotechnologies

Risk Impact of Multivariate Predictive ModelsHaleh Valian, Ph.D., Manager, Global Process Analytics, Biogen

PANEL DISCUSSION: How to Overcome the Funding Gap for Biotech Start-ups and Emerging Companies• What is the impact to the industry, when so many great start-ups

with great technologies fail in early stages due to a gap in early-stage funding?

• How can the biopharma industry stimulate innovation without initial financing for companies to help them succeed?

• Is there any middle ground between financiers’ interests in later stage companies (ph. 2 and beyond) and emerging companies need for cash in order to even survive to phase 2?

Panelists:Barbara Fox, Ph.D., Entrepreneur-in-Residence, Partners Innovation Fund and Former CEO, Avaxia BiologicsOhad Karnieli, Ph.D., Co-founder & Chief Technology Officer, Karnieli Ltd., IsraelTyler G. Merkeley, Health Scientist, Chief of Staff (Acting) and Head of Special Projects & Portfolio Management, BARDA Joshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc.

3:30 Driving Value for Cell Culture Commercial Manufacturing Through Process Understanding and Continuous Improvements Nefiola Kaso, Senior Scientist I, Manufacturing Sciences, AbbVie

Enabling Manufacturing of Affordable Biologics Through the Use of Protein A Membrane in a Single Use Purification StrategyRenaud Jacquemart, Ph.D., Principal Scientist, Process Sciences, Natrix Separations Inc.

Freeze Dryer Characterization to Enable Modeling: Going Beyond the FATAnthony Gudinas, Principal Scientist, Pharmaceutical Sciences, Pfizer, Inc.

3:30 Implementation of Comprehensive End to End process monitoring for Understanding Variability and Improving Product Robustness Syama Adhibhatta, Associate Director Process Modelling & Analytics, Biologics Manufacturing Sciences and Technology, Bristol-Myers Squibb

Analytical Testing Strategy for Kadcyla® Cleaning Validation and Lessons Learned from ADC Drug Product Transfer to a CMOLan Dai, Ph.D., QC Associate Scientist, Global Biologics Quality Control, Genentech Inc., A Member of the Roche Group

4:00 Networking Refreshment Break in the Exposition Hall 4:00 Networking Refreshment Break in the Exposition Hall

Novel Single-Use Applications in Cell CultureSponsored by:

Novel Impurity Removal and Validation Strategies to Accelerate and De-Risk Development STAT Panel Discussion STAT Panel Discussion

5:00 Scale-Up to 2000L Single-Use Bioreactors, A Case Study in Reactor and Process Characterization Nienke Vriezen, Head, Upstream Biotechnology, Synthon Biopharmaceuticals BV

A Comprehensive Impurity Removal Strategy for Protein A to Simplify mAb Purification Process for Early Phase MoleculeLu Wang, Ph.D., Senior Scientist, CMC Downstream, Teva Pharmaceutical Inc.

Health and the Election: The Implications of Promises and Policy on Pricing and other Issues that MatterModerator: Rick Berke, Executive Editor, STAT (STATnews.com)

5:00 Health and the Election: The Implications of Promises and Policy on Pricing and other Issues that MatterModerator: Rick Berke, Executive Editor, STAT (STATnews.com)

5:30 Developing Single Use Technology (SUT) Cell Expansion rocess to Improve Legacy Cell Culture Processes Jean Hsu, Process Engineer III, MSAT Lab, Sanofi

Leveraging Mechanistic Chromatography Modeling to Streamline QbD Process Validation of Biologics James A. Patch, Ph.D., Principal Engineer, Purification Development, Genentech, Inc.

6:15 Party In the Park 6:15 Party In the Park


17


Cell Culture Recovery & Purification Drug Product Manufacturing & Fill-Finish Processing Manufacturing Strategy Analytical, Formulation and Quality Early Stage Biologics and Companies

2:25 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksMark Yang, Ph.D., Director of Fill Finish Development, Sanofi Genzyme

2:25 Chairperson’s RemarksTBA, FUJIFILM Diosynth Biotechnologies

Chairperson’s RemarksMelissa Morandi, Vice President, Global Quality, Aegerion Pharmaceuticals

Chairperson’s RemarksJoshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc.

Improving Process Understanding, Control, and Productivity at Clinical and Commercial Scale Featured Presentation Drug Product Case Studies: Residual Moisture,

ADCs and Freeze Dryer CharacterizationManufacturing for Late Stage Development and

Commercial Products Sponsored by:

Quality Risk Assessment and QC Testing Strategies Funding Strategies for Early Stage Companies

2:30 Developing Robust Control Strategies for Sustainable Upstream Commercial Manufacturing Kartik Subramanian, Ph.D., Principal Scientist and Group Leader, Manufacturing Sciences, AbbVie

Presentation Title TBDGünter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, BioProcess Division, Sweden

Case Study: Residual Moisture in Lyophilized Drug Product, How Much Is Too Much? Mark Yang, Ph.D., Director of Fill Finish Development, Sanofi Genzyme

2:30 Bioreactor Process Improvements in a Legacy Perfusion-based Process Jiayi Zhang, Ph.D., Manager Process Engineering Development, MSAT, Genzyme

Risk Assessment across the Entire Quality System and CompanyMelissa Morandi, Vice President, Global Quality, Aegerion Pharmaceuticals

Funding a Therapeutic-Focused Company through Angels: The Good, The Bad and the UglyBarbara Fox, Ph.D., Entrepreneur-in-Residence, Partners Innovation Fund and Former CEO, Avaxia Biologics

Novel Chromatographic Selectivities & Innovative Materials for Next Generation

Purification3:00 Optimization of Productivity and Targeted

Modulation of Product Quality Attributes of a Phase III IgG Utilizing the Ambr15 PlatformMichael A. Bennett, MSc., Scientist, Process Development, Patheon

Performance of Next Generation High Capacity Anion Exchange Media in mAb Purification Debola Banerjee, M.Tech, Engineer II, Purification Development, Genentech, Inc.

Evaluation of Quality Attributes of an Antibody-Drug Conjugate (ADC 1) Following Extended Storage in a Stainless Steel ContainerAmy Leung, Scientist I, ImmunoGen, Inc.

3:00 Manufacturing for Late Phase DevelopmentSpeaker TBA, FUJIFILM Diosynth Biotechnologies

Risk Impact of Multivariate Predictive ModelsHaleh Valian, Ph.D., Manager, Global Process Analytics, Biogen

PANEL DISCUSSION: How to Overcome the Funding Gap for Biotech Start-ups and Emerging Companies• What is the impact to the industry, when so many great start-ups

with great technologies fail in early stages due to a gap in early-stage funding?

• How can the biopharma industry stimulate innovation without initial financing for companies to help them succeed?

• Is there any middle ground between financiers’ interests in later stage companies (ph. 2 and beyond) and emerging companies need for cash in order to even survive to phase 2?

Panelists:Barbara Fox, Ph.D., Entrepreneur-in-Residence, Partners Innovation Fund and Former CEO, Avaxia BiologicsOhad Karnieli, Ph.D., Co-founder & Chief Technology Officer, Karnieli Ltd., IsraelTyler G. Merkeley, Health Scientist, Chief of Staff (Acting) and Head of Special Projects & Portfolio Management, BARDA Joshua Speidel, Ph.D., Managing Director, Commercial Practice Lead, Latham BioPharm Group, Inc.

3:30 Driving Value for Cell Culture Commercial Manufacturing Through Process Understanding and Continuous Improvements Nefiola Kaso, Senior Scientist I, Manufacturing Sciences, AbbVie

Enabling Manufacturing of Affordable Biologics Through the Use of Protein A Membrane in a Single Use Purification StrategyRenaud Jacquemart, Ph.D., Principal Scientist, Process Sciences, Natrix Separations Inc.

Freeze Dryer Characterization to Enable Modeling: Going Beyond the FATAnthony Gudinas, Principal Scientist, Pharmaceutical Sciences, Pfizer, Inc.

3:30 Implementation of Comprehensive End to End process monitoring for Understanding Variability and Improving Product Robustness Syama Adhibhatta, Associate Director Process Modelling & Analytics, Biologics Manufacturing Sciences and Technology, Bristol-Myers Squibb

Analytical Testing Strategy for Kadcyla® Cleaning Validation and Lessons Learned from ADC Drug Product Transfer to a CMOLan Dai, Ph.D., QC Associate Scientist, Global Biologics Quality Control, Genentech Inc., A Member of the Roche Group


Novel Single-Use Applications in Cell CultureSponsored by:

Novel Impurity Removal and Validation Strategies to Accelerate and De-Risk Development STAT Panel Discussion STAT Panel Discussion

5:00 Scale-Up to 2000L Single-Use Bioreactors, A Case Study in Reactor and Process Characterization Nienke Vriezen, Head, Upstream Biotechnology, Synthon Biopharmaceuticals BV

A Comprehensive Impurity Removal Strategy for Protein A to Simplify mAb Purification Process for Early Phase MoleculeLu Wang, Ph.D., Senior Scientist, CMC Downstream, Teva Pharmaceutical Inc.

Health and the Election: The Implications of Promises and Policy on Pricing and other Issues that MatterModerator: Rick Berke, Executive Editor, STAT (STATnews.com)

5:00 Health and the Election: The Implications of Promises and Policy on Pricing and other Issues that MatterModerator: Rick Berke, Executive Editor, STAT (STATnews.com)

5:30 Developing Single Use Technology (SUT) Cell Expansion rocess to Improve Legacy Cell Culture Processes Jean Hsu, Process Engineer III, MSAT Lab, Sanofi

Leveraging Mechanistic Chromatography Modeling to Streamline QbD Process Validation of Biologics James A. Patch, Ph.D., Principal Engineer, Purification Development, Genentech, Inc.

6:15 Party In the Park 6:15 Party In the Park


18

FRIDAY, OCTOBER 7, 2016



8:00 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksStuart Wang, Ph.D., Senior Scientist, Protein Pharmaceutical Development, Biogen

8:00 Chairperson’s RemarksRajesh Beri, Ph.D., Technical Director Research & Technology, BioManufacturing, Lonza Biologics

Chairperson’s RemarksGanapathy Gopalrathnam, Senior Research Scientist, Lilly Research Laboratories, Eli Lilly & Co.

Development and Production of New Modalities Innovations in High-Throughput Development & Process Modeling

Case Studies: Visual Particles, Process Characterization and Scale-up

Flexible Designs and Considerations for New and Aging Manufacturing Facilities Formulation Strategies for Biologics

8:05 Late Stage Process Development of a Bispecific Antibody using QbD Approach Jiuyi Lu, Ph.D., Scientist, BioPharmaceutics Development, Sanofi

Leveraging a High Throughput Flocculation Platform to Increase the Capacity and Reduce the Size of Downstream Purification TrainAaron Noyes, Eng.D, Senior Scientist, Purification Process Development, Pfizer Bioprocess R&D

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology Derived Injectable Drug ProductsMaryam Mazaheri, Associate Project Manager - CMC, MedImmune, Inc.

8:05 A New Stainless Steel Manufacturing Facility: Flexibility without ComplexityJoseph Neal, Scientist I, MS&T, Supply Biologics, AstraZeneca

Metal-catalyzed Oxidation of Polysorbates in Histidine Buffer SystemGanapathy Gopalrathnam, Senior Research Scientist, Lilly Research Laboratories, Eli Lilly & Co.

8:35 Flublok Manufacturing using BaculovirusWafaa Mahmoud, Ph.D., Manager, Product Development, USP, Protein Sciences

A Holistic Approach to Inform Bioprocess Design and Operation: Case Studies Illustrating the Application of Ultra Scale-Down Tools for High Throughput Bioprocess Studies of Linked Recovery Unit OperationsAndrea Rayat, Senior Enterprise Fellow, Bioprocessing, MSC., The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, United Kingdom

The Role of Equipment and Container Characterizations in Process Scale Up in Dual Chamber SyringeStuart Wang, Ph.D., Senior Scientist, Protein Pharmaceutical Development, Biogen

8:35 Enabling Flexibility through Automation for a New Manufacturing FacilityRyan Hogan, Scientist I, Manufacturing Sciences and Technology,AstraZeneca

Revisiting Achilles Heel of PBS: Modified PBS and Freeze Thaw Stability of Monoclonal AntibodyTatyana Mezhabovsky, Ph.D., Principal Scientist, BioFormulations Development, Sanofi R&D

Plenary Keynote Speaker Keynote Speaker 9:15

Innovation & Customer CentricitySteve Wozniak, Co-founder, Apple Computer Inc.



11:00 Plant-Based Manufacturing for Ebola Therapeutics Chia-Wei Tsai, Ph.D., Branch Chief, Antiviral and Antitoxin Program, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health & Human Services (HHS)

Modulation of Protein Biophysical Properties with Small Molecule in Purification and FormulationFrancis Insaidoo, Ph.D., Senior Scientist, Process Development and Enfgineering, Merck & Co., Inc.

In-silico Process Characterization of Filling Operations: Predicting Quality Attributes from First PrinciplesWill Johnson, Ph.D., Principal Engineer, Digital Integration & Predictive Technologies, Amgen, Inc.

11:00 Innovative Strategies Optimizing Capacity and Flexibility in the Amgen, RI Biomanufacturing PlantJessica Morse, Senior Manager Cell Culture, Amgen

Pediatric Formulation ConsiderationsAnant N. Sharma, Formulation Scientist, Lilly Research Laboratories, Eli Lilly & Co.

11:30 Solving Production Challenges of Difficult-to-Express Proteins with a Scalable, Continuous Manufacturing Bioreactor: A Case Study Scott Waniger, Vice President, BioServices Division, Cell Culture Company

Development and Integration of Process Models into Legacy Manufacturing Processes to Improve Performance and Product QualityNathan Lee, MSc., Senior Engineer, Manufacturing Technology, Bristol-Myers Squibb


11:30 Experimental Data Supporting Risk-Based Biopharmaceutical Facility Design ApproachesJeffrey Johnson, New Technology Lead and Director, Center forBioManufacturing Sciences, Merck & Co., Inc.

Pediatric Formulations and Challenges Manufacturing Pediatric DosagesMichael Colacino, Senior Director, Global Manufacturing, Aegerion Pharmaceuticals

12:00 High Titer Production of Knob-In-Hole Bispecific Antibodies in E.coliJames Giulianotti, Senior Research Associate, Early Stage Cell Culture, Genentech, Inc.

Evaluation and Integration of High Throughput Chromatography into Process Characterization Sethu Siva, MSc., Associate Scientist III, Technical Development, Biogen

Case Study and Considerations for Live-Cell FillingMichael Zdanowski, Vice President, Manufacturing, Mesoblast

12:00 Evaluating Risk of Components in Aging FacilitiesChristopher Smalley, Ph.D., Director, Engineering, Global Technical Operations, Merck & Co.

Analytical Strategies for Biologic Combination Therapies Lynn Gennaro, Ph.D., Associate Director, Analytical Development and Quality Control, Genentech


1:05 Networking Luncheon and Last Chance for Exposition Hall Viewing 1:05 Networking Luncheon and Last Chance for Exposition Hall Viewing


19

FRIDAY, OCTOBER 7, 2016



8:00 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksStuart Wang, Ph.D., Senior Scientist, Protein Pharmaceutical Development, Biogen

8:00 Chairperson’s RemarksRajesh Beri, Ph.D., Technical Director Research & Technology, BioManufacturing, Lonza Biologics

Chairperson’s RemarksGanapathy Gopalrathnam, Senior Research Scientist, Lilly Research Laboratories, Eli Lilly & Co.

Development and Production of New Modalities Innovations in High-Throughput Development & Process Modeling

Case Studies: Visual Particles, Process Characterization and Scale-up

Flexible Designs and Considerations for New and Aging Manufacturing Facilities Formulation Strategies for Biologics

8:05 Late Stage Process Development of a Bispecific Antibody using QbD Approach Jiuyi Lu, Ph.D., Scientist, BioPharmaceutics Development, Sanofi

Leveraging a High Throughput Flocculation Platform to Increase the Capacity and Reduce the Size of Downstream Purification TrainAaron Noyes, Eng.D, Senior Scientist, Purification Process Development, Pfizer Bioprocess R&D

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology Derived Injectable Drug ProductsMaryam Mazaheri, Associate Project Manager - CMC, MedImmune, Inc.

8:05 A New Stainless Steel Manufacturing Facility: Flexibility without ComplexityJoseph Neal, Scientist I, MS&T, Supply Biologics, AstraZeneca

Metal-catalyzed Oxidation of Polysorbates in Histidine Buffer SystemGanapathy Gopalrathnam, Senior Research Scientist, Lilly Research Laboratories, Eli Lilly & Co.

8:35 Flublok Manufacturing using BaculovirusWafaa Mahmoud, Ph.D., Manager, Product Development, USP, Protein Sciences

A Holistic Approach to Inform Bioprocess Design and Operation: Case Studies Illustrating the Application of Ultra Scale-Down Tools for High Throughput Bioprocess Studies of Linked Recovery Unit OperationsAndrea Rayat, Senior Enterprise Fellow, Bioprocessing, MSC., The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, United Kingdom

The Role of Equipment and Container Characterizations in Process Scale Up in Dual Chamber SyringeStuart Wang, Ph.D., Senior Scientist, Protein Pharmaceutical Development, Biogen

8:35 Enabling Flexibility through Automation for a New Manufacturing FacilityRyan Hogan, Scientist I, Manufacturing Sciences and Technology,AstraZeneca

Revisiting Achilles Heel of PBS: Modified PBS and Freeze Thaw Stability of Monoclonal AntibodyTatyana Mezhabovsky, Ph.D., Principal Scientist, BioFormulations Development, Sanofi R&D

Plenary Keynote Speaker Keynote Speaker 9:15




11:00 Plant-Based Manufacturing for Ebola Therapeutics Chia-Wei Tsai, Ph.D., Branch Chief, Antiviral and Antitoxin Program, Division of CBRN Countermeasures, Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health & Human Services (HHS)

Modulation of Protein Biophysical Properties with Small Molecule in Purification and FormulationFrancis Insaidoo, Ph.D., Senior Scientist, Process Development and Enfgineering, Merck & Co., Inc.

In-silico Process Characterization of Filling Operations: Predicting Quality Attributes from First PrinciplesWill Johnson, Ph.D., Principal Engineer, Digital Integration & Predictive Technologies, Amgen, Inc.

11:00 Innovative Strategies Optimizing Capacity and Flexibility in the Amgen, RI Biomanufacturing PlantJessica Morse, Senior Manager Cell Culture, Amgen

Pediatric Formulation ConsiderationsAnant N. Sharma, Formulation Scientist, Lilly Research Laboratories, Eli Lilly & Co.

11:30 Solving Production Challenges of Difficult-to-Express Proteins with a Scalable, Continuous Manufacturing Bioreactor: A Case Study Scott Waniger, Vice President, BioServices Division, Cell Culture Company

Development and Integration of Process Models into Legacy Manufacturing Processes to Improve Performance and Product QualityNathan Lee, MSc., Senior Engineer, Manufacturing Technology, Bristol-Myers Squibb


11:30 Experimental Data Supporting Risk-Based Biopharmaceutical Facility Design ApproachesJeffrey Johnson, New Technology Lead and Director, Center forBioManufacturing Sciences, Merck & Co., Inc.

Pediatric Formulations and Challenges Manufacturing Pediatric DosagesMichael Colacino, Senior Director, Global Manufacturing, Aegerion Pharmaceuticals

12:00 High Titer Production of Knob-In-Hole Bispecific Antibodies in E.coliJames Giulianotti, Senior Research Associate, Early Stage Cell Culture, Genentech, Inc.

Evaluation and Integration of High Throughput Chromatography into Process Characterization Sethu Siva, MSc., Associate Scientist III, Technical Development, Biogen

Case Study and Considerations for Live-Cell FillingMichael Zdanowski, Vice President, Manufacturing, Mesoblast

12:00 Evaluating Risk of Components in Aging FacilitiesChristopher Smalley, Ph.D., Director, Engineering, Global Technical Operations, Merck & Co.

Analytical Strategies for Biologic Combination Therapies Lynn Gennaro, Ph.D., Associate Director, Analytical Development and Quality Control, Genentech


1:05 Networking Luncheon and Last Chance for Exposition Hall Viewing 1:05 Networking Luncheon and Last Chance for Exposition Hall Viewing

7:15 Technology Workshop with Light Continental Breakfast

Accelerating Mammalian and Microbial Culture with Single-Use TechnologyTBA

12:15 Technology Workshops

Unlocking Downstream EfficiencyTBA


20


2:25 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksJulie Zhu, Ph.D., Associate Director, Pharmaceutical Development & Manufacturing Sciences (PDMS), Janssen Research & Development

2:25 Chairperson’s RemarksNandu Deorkar, Ph.D., Vice President, Research and Development, Avantor Performance Materials

Chairperson’s RemarksQin Zou, Ph.D., Senior Principal Scientist, Analytical R&D, Pfizer, Inc.

Impact of Process Conditions on Product Quality Process Integration & Intensification Drug Product and Fill-Finish Strategies

for Cell Therapy Products

Strategies to Control Raw Material Variability and to Improve Supply Chain Transparency and Security

Sponsored by:


2:30 Expanding the Glycan Code for Mammalian Expressed Glycoproteins Patrick M. Hossler, Ph.D., Principal Research Scientist, Process Sciences, AbbVie Inc.

Evolution, Process, and Challenges of Viral FiltrationDayue Chen, Ph.D., Senior Research Advisor, Bioprocess Research and Development, Eli Lilly and Company

Fill & Finish Operations for Cell Therapy Products: Challenges and OpportunitiesMaria del Pilar Redondo, Pharm.D., Senior Director, Technical Operations, TiGenix, Spain

2:30 Controlling Raw Material Variability Improves the Biopharmaceutical Process Consistency and Product QualityNandu Deorkar, Ph.D., Vice President, Research and Development, Avantor Performance Materials

Developing 1D Proton NMR Analysis for Higher Order Structural Similarity of Therapeutic Antibodies: Application of Spin-Diffusion EditingQin Zou, Ph.D., Senior Principal Scientist, Analytical R&D, Pfizer, Inc.

3:00 Process Conditions and Misincorporations Bruno Figueroa, Ph.D., Associate Research Fellow, Pfizer

Resin Multi-Product Use – Past, Present, and Future Yolanda Ng, Purification Pilot Plant Technical Specialist, PTDUO, Genentech, Inc.

Late Phase Fill-Finish Process Development Challenges-Case Study for A Cell Therapy Product Julie Zhu, Ph.D., Associate Director, Pharmaceutical Development & Manufacturing Sciences (PDMS), Janssen Research & Development

3:00 Evaluation of Advanced Media/Feed Characterization Methods for an Improved Understanding of Media/Feed Variability Rajesh Beri, Ph.D., Technical Director Research & Technology, BioManufacturing, Lonza Biologics

MoA Reflecting Bioassays to Confirm BiosimilarityUlrike Herbrand, Ph.D., Scientific Officer, Charles River Biopharmaceutical Services GmbH, Germany

3:30 Elemental Metals and Impact on Product Quality Attributes Rashmi Kshirsagar, Ph.D., Director, Technical Development, Biogen

High Concentration Ultrafiltration: Effect of Tangential Flow Filtration Cassette Design and Operating Parameters on Process PerformanceDharmesh Kanani, Senior Scientist, Downstream Development & Operations, Teva R&D Biologics CMC TBU, Teva Pharmaceutical Inc.

Scale-up and Production Challenges in Cell Therapy FillingBrian Murphy, Ph.D., Director of Bioprocess Development, Celgene Cellular Therapeutics

3:30 Building the Foundations for Excellence in Biopharmaceutical Raw Material Supply ChainsPrateek Gadhoke, Associate Director, Bioprocess Materials, Bristol-Myers Squibb

Analytical Strategy for N-Glycan Profiling Analysis for mAbs – Comparison of a High Throughput Method vs a High Resolution MethodMelissa Schwartz, Scientist II, Analytical Science, Boehringer Ingelheim

4:00 Production of Sialylated Monoclonal Antibody in CHO Cells Yves Durocher, Ph.D., Research Officer, Antibodies and Bioprocessing, National Research Council Canada

INTEGRATED DOWNSTREAM PROCESSING ROUNDTABLE DISCUSSION Future of Automation, Integration and Intensification - Technical and Platform Compatibility - A Wholistic and Mojular Approach to Process IntegrationModerator: Natraj Ram, Ph.D., Associate Director, Purifiaction, Manufacturing Sciences, AbbVie Inc.

Cell Therapy Fill & Finish: New Challenges and Possible Innovative SolutionsOhad Karnieli, Ph.D., Co-founder & Chief Technology Officer, Karnieli Ltd, Israel

4:00 Protecting the Patient through Enhanced Supply Chain SecurityRob Welsh, Vice President, Bioprocessing Segment Solutions, VWR and Rx-360 International Pharmaceutical Supply Chain Consortium Board Member & Co-Chair of Supply Chain Security Steering Committee

Developing Technologies for Comparability Studies of Carbohydrate Containing BiosimilarsParastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia

4:30 Close of Conference 4:30 Close of Conference

FRIDAY, OCTOBER 7, 2016 (CONTINUED)


21


2:25 Chairperson’s Remarks Chairperson’s Remarks Chairperson’s RemarksJulie Zhu, Ph.D., Associate Director, Pharmaceutical Development & Manufacturing Sciences (PDMS), Janssen Research & Development

2:25 Chairperson’s RemarksNandu Deorkar, Ph.D., Vice President, Research and Development, Avantor Performance Materials

Chairperson’s RemarksQin Zou, Ph.D., Senior Principal Scientist, Analytical R&D, Pfizer, Inc.

Impact of Process Conditions on Product Quality Process Integration & Intensification Drug Product and Fill-Finish Strategies

for Cell Therapy Products

Strategies to Control Raw Material Variability and to Improve Supply Chain Transparency and Security

Sponsored by:


2:30 Expanding the Glycan Code for Mammalian Expressed Glycoproteins Patrick M. Hossler, Ph.D., Principal Research Scientist, Process Sciences, AbbVie Inc.

Evolution, Process, and Challenges of Viral FiltrationDayue Chen, Ph.D., Senior Research Advisor, Bioprocess Research and Development, Eli Lilly and Company

Fill & Finish Operations for Cell Therapy Products: Challenges and OpportunitiesMaria del Pilar Redondo, Pharm.D., Senior Director, Technical Operations, TiGenix, Spain

2:30 Controlling Raw Material Variability Improves the Biopharmaceutical Process Consistency and Product QualityNandu Deorkar, Ph.D., Vice President, Research and Development, Avantor Performance Materials

Developing 1D Proton NMR Analysis for Higher Order Structural Similarity of Therapeutic Antibodies: Application of Spin-Diffusion EditingQin Zou, Ph.D., Senior Principal Scientist, Analytical R&D, Pfizer, Inc.

3:00 Process Conditions and Misincorporations Bruno Figueroa, Ph.D., Associate Research Fellow, Pfizer

Resin Multi-Product Use – Past, Present, and Future Yolanda Ng, Purification Pilot Plant Technical Specialist, PTDUO, Genentech, Inc.

Late Phase Fill-Finish Process Development Challenges-Case Study for A Cell Therapy Product Julie Zhu, Ph.D., Associate Director, Pharmaceutical Development & Manufacturing Sciences (PDMS), Janssen Research & Development

3:00 Evaluation of Advanced Media/Feed Characterization Methods for an Improved Understanding of Media/Feed Variability Rajesh Beri, Ph.D., Technical Director Research & Technology, BioManufacturing, Lonza Biologics

MoA Reflecting Bioassays to Confirm BiosimilarityUlrike Herbrand, Ph.D., Scientific Officer, Charles River Biopharmaceutical Services GmbH, Germany

3:30 Elemental Metals and Impact on Product Quality Attributes Rashmi Kshirsagar, Ph.D., Director, Technical Development, Biogen

High Concentration Ultrafiltration: Effect of Tangential Flow Filtration Cassette Design and Operating Parameters on Process PerformanceDharmesh Kanani, Senior Scientist, Downstream Development & Operations, Teva R&D Biologics CMC TBU, Teva Pharmaceutical Inc.

Scale-up and Production Challenges in Cell Therapy FillingBrian Murphy, Ph.D., Director of Bioprocess Development, Celgene Cellular Therapeutics

3:30 Building the Foundations for Excellence in Biopharmaceutical Raw Material Supply ChainsPrateek Gadhoke, Associate Director, Bioprocess Materials, Bristol-Myers Squibb

Analytical Strategy for N-Glycan Profiling Analysis for mAbs – Comparison of a High Throughput Method vs a High Resolution MethodMelissa Schwartz, Scientist II, Analytical Science, Boehringer Ingelheim

4:00 Production of Sialylated Monoclonal Antibody in CHO Cells Yves Durocher, Ph.D., Research Officer, Antibodies and Bioprocessing, National Research Council Canada

INTEGRATED DOWNSTREAM PROCESSING ROUNDTABLE DISCUSSION Future of Automation, Integration and Intensification - Technical and Platform Compatibility - A Wholistic and Mojular Approach to Process IntegrationModerator: Natraj Ram, Ph.D., Associate Director, Purifiaction, Manufacturing Sciences, AbbVie Inc.

Cell Therapy Fill & Finish: New Challenges and Possible Innovative SolutionsOhad Karnieli, Ph.D., Co-founder & Chief Technology Officer, Karnieli Ltd, Israel

4:00 Protecting the Patient through Enhanced Supply Chain SecurityRob Welsh, Vice President, Bioprocessing Segment Solutions, VWR and Rx-360 International Pharmaceutical Supply Chain Consortium Board Member & Co-Chair of Supply Chain Security Steering Committee

Developing Technologies for Comparability Studies of Carbohydrate Containing BiosimilarsParastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia

4:30 Close of Conference 4:30 Close of Conference

FRIDAY, OCTOBER 7, 2016 (CONTINUED)


22

ABL, IncAdvanced InstrumentsAdvantaPure / NewAge IndustriesAgilent TechnologiesAltheaANGUS Life SciencesApplikon BiotechnologyAragen BioscienceAsahi Kasei BioprocessAvantor Performance MaterialsAvid BioservicesBDBeckman Coulter Life ScienceBend Research, a division of CapsugelBerkeley Lights, IncBIA Separations d.o.o.Bio-Rad LaboratoriesBionova Scientific, IncBioTechLogicBoehringer IngelheimBroadley JamesBTEC/North Carolina State University CatalentCell Culture Company

Charles RiverCharter MedicalChemglass Life SciencesCMC BiologicsCook PharmicaCorning IncorporatedCPCCustom Biogenic SystemsCytovance BiologicsDistek, IncDNA 2.0em-tec Flow Technology LPEmergent BioSolutionsEntegrisEnzo Life SciencesEppendorfEssential PharmaceuticalsEurofins Lancaster LabsEvonik CorporationFarrar Scientific CorporationFiltrox AGFinesse SolutionsFlownamicsFrieslandCampina IngredientsFujifilm Diosynth Biotechnologies

GE HealthcareGenetic Engineering & Biotechnology NewsGyros US, IncHamilton CompanyIDBSILC DoverInfors USAIntegra CompaniesIntegrated Project Management Company, IncIrvine ScientificJSR Life SciencesKaiser Optical SystemsKanekaKBI BiopharmaKemwell BiopharmaKerryKuhner ShakerLevitronixLEWA Nikkiso AmericaLonzaMabPlexMalema SensorsMasy BioServices

MaxCyteMeissner Filtration ProductsMilliporeSigma Molecular DevicesNordson MedicalNova BiomedicalNovasepNovo Nordisk Pharmatech A/SOetiker, Inc..optek-Danulat, Inc.Pall Life SciencesParagon BioservicesParker domnick hunterPendoTECHPfizer, One 2 OneProMetic BiosciencesPuroliteQosinaRefine Technology LLC Rentschler Biotechnologie GmbHRepligenRoche Saint-GobainSandozSaniSure

Sartorius Stedim BiotechSGS SpectrumLabs.comStrain Measurement DevicesTecanTerumo BCT Therapure BiomanufacturingThermo Fisher ScientificTosoh Bioscience LLCToxikon Corporation TransonicUnchained LabsVacciXell Vironova ABVR Analytical Watson-Marlow Fluid Technology GroupWest Pharmaceutical Services WPI Biomanufacturing Ed. & Training Cntr.WuXi AppTec / WuXi BiologicsYMC America, Inc.YSI, Inc

EXHIBITORS (As of June 7, 2016)

"This show brings in the end-users - we get great quality leads" - Kelly Jakinovich, Associate Sales Engineer,

Saint Gobain

"We get more good leads at BPI than any Show – including Interphex" - Gary Gaudet, Clean Market Manager, LEWA, Inc.

"BPI is a great opportunity to meet leaders, and innovators in this industry." - Holzer Margit, VP R&D and Technology,

Novasep

Find out what the best level of sponsorship is for your organizationA-L: JENNIFER WICKETT • 508.614.1672 • [email protected] | M-Z: KRISTEN SCHOTT • 508.614.1239 • [email protected]

SPONSORSHIP & EXHIBITION OPPORTUNITIES

1,800+BPI attracts more than 1800 attendees each year providing you more networking and business opportunities than any other bioprocessing event on the market.

JOB LEVEL

5%Associate/Analyst/Account Executive/Specialist

8%C-Level

5%Other

29%(Sr) Dir/Scientist/Engineer

24%VP/SVP/EVP

19%Manager/Scientist/

Engineer

9%Head/Lead/Partner/Strategist/Principal

COMPANY TYPE

CRO

Academia/Govt.

Pharma/Biotech

Other

Solution Provider

Consultant/Agency

Drug Delivery

14%

4%

31%

8%

1%

26%

16%US & Canada 86%

APAC 2%Europe 10%

Rest of World 2%

GEOGRAPHYWHO WILL YOU MEET?

23

EVENT PARTNERS

The Life Sciences business of GE Healthcare provides a wide range of bioprocessing solutions for the development and manufacture of high-quality biotherapeutics and vaccines. Using our expertise, we support our customers in increasing speed to market, while reducing costs and improving performance in drug manufacturing. As a provider of high-quality products, technical and commercial services, as well as design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.

Pall Life Sciences provides process, pilot and laboratory filtration, separation, purification and fluid handling devices, systems and services, with single-use systems available for all unit operations from cell culture through final formulation and filling. Based on Pall’s long history of providing quality equipment for the

biopharmaceutical, vaccine and cell therapy industries, all products - whether standard or customized to match users exact process needs - are backed up with extensive documentation and experience in extractables, leachables and particulate validation. Fully automated single-use systems allow process control and data acquisition to meet or exceed the standards expected from traditional fixed equipment. New product highlights include microcarriers, pyrogen-free vials and a range of pharmaceutical packaging.

As a total solution provider, Sartorius Stedim Biotech merges one of the broadest portfolios of single-use components, hybrid or traditional stainless steel systems, and services in the market. Our integrated solutions cover fermentation, cell cultivation, filtration and fluid management as well as purification and lab technologies. Visit booth #717 to learn more about all Sartorius Stedim Biotech has to offer!

PLATINUM SPONSORS

TBA

Roche Custom Biotech supplies reagents, analytical methods, and services customized to meet the quality and regulatory needs of our customers. We offer customization, contract development, and manufacturing in nearly all fields of our portfolio, including custom antibodies and enzymes. Our product portfolio includes a wide range of GMP manufactured products used in inprocess quality control testing, enzymes for dissociating cells from primary tissues, downstream proteases, and biocatalysts. With a portfolio of over one thousands products, we can specifically modify existing products, custom manufacture to your needs, or provide consultancy on the development of completely new items.

GOLD SPONSOR

Bio-Rad Laboratories is a leading global provider of innovative tools to the life science and clinical diagnostics markets with more than 60 years of experience, where the company’s products are used for scientific discovery, drug development, and biopharmaceutical production. Bio-Rad’s Life Science Group has long served the bioprocessing industry with innovative process separation technologies. Bio-Rad provides a full line of scalable process chromatography resins to meet your purification needs with worldwide access and personalized service and support.

SILVER SPONSOR

Fujifilm Diosynth Biotechnologies is a full service Contract Development & Manufacturing Organization (CDMO) focused in clinical & commercial cGMP contract manufacturing of complex recombinant proteins, vaccines, antibodies, fusion proteins, etc.

BRONZE SPONSORS

SESSION SPONSORS

PRESENTATION/TECHNOLOGY WORKSHOP SPONSORS

LUNCHEON PRESENTATION SPONSORS

WELCOME BREAKFAST PRESENTATION SPONSOR

OPENING NIGHT “CELEBRATION OF SCIENCE” RECEPTION CO-SPONSOR

BPI “BIOBREW” SPONSOR BEER GARDEN SPONSOR

BPI THEATER SHOWCASE SPONSORS

WIFI SPONSOR LOUNGE SPONSOR

Find out what the best level of sponsorship is for your organizationA-L: JENNIFER WICKETT • 508.614.1672 • [email protected] | M-Z: KRISTEN SCHOTT • 508.614.1239 • [email protected]

MEET THE PEOPLE BEHIND THE PRODUCTS & GET THE ANSWERS YOU NEED

24

RECEPTION IN THE EXPOSITION HALLKick off your conference experience at the Opening Night Party to celebrate the launch of Biotech Week Boston! Explore our “Celebration of Science” theme with a taste of molecular gastronomy from Boston’s celebrity chefs. The party will feature “Dueling DJ’s”, from the theater zone while you catch up with colleagues and friends, network with attendees, exhibitors and sponsors. Participate in several interactive activities and/or relax in one of the themed lounge areas. Enjoy a fun evening with food, drinks and entertainment.

LOCATED IN THE HEART OF THE EXPOSITION HALLThe Theater Zone stage in the exposition hall will provide an information-packed agenda of industry-critical information in a variety of formats including presentations, panel discussions, product demonstrations, Q&A sessions, interviews and much more. Theater Zone speakers and attendees will share a communal learning experience as they present, discuss, and debate the latest scientific and business trends impacting the biotech and pharmaceutical fields. Please visit the conference website for a full agenda of Theater Zone presentations and activities.

If you are interested in participating in the Theater Zone or you would like to propose a speaker, panel discussion topic or interview subject, please contact Michael Keenan.

[email protected] or call 949-276-2634.

OPENING NIGHT RECEPTION

THEATER ZONE

BPI "BIO BREW" EVENT

CELEBRATION OF SCIENCE

TUES, OCT. 4TH | 7:30 pm -10:30 pm

WED, OCT. 5TH | 4:30 pm - 6:30 pm

Catch the shuttle outside the BCEC for the BPI “BioBrew” Networking Event @ Harpoon Brewery (limited capacity; registration required)

EXPOSITION & EVENT ACTIVITIES

Sponsored by

TUES, OCT. 4TH Sartorius will be hosting a Site Tour to the UniQure Facility in Lexington, MA Buses will leave the Boston Convention & Exhibition Center at 1:00pm and will return at 6:00pm.(limited capacity; registration required)

SITE TOUR TO UNIQURE

Sponsored by

Close out the last night with a bang at Party In the Park. Come and party at a first-of-its-kind outdoor interactive space in Boston, The Lawn on D.This unique outdoor interactive experience will be filled with Bocce courts, ping-pong tables, cornhole, KanJam games. Party In the Park will feature a Main Stage under the tent with “awesome” soon to be announced entertainment. There will be great food and drinks, food trucks, interactive activities (did someone say photo booths?) for everyone. These are the reasons why Party In the Park promises to be a night to remember!This event is free for all attendees, but an advance RSVP is required to reserve your spot. Please select the “Party In the Park” option when you register for the conference.

2016 BIOPROCESS INTERNATIONAL AWARDSGALA AWARD DINNER & CEREMONYDon’t miss this special, bi-annual evening created to recognize and honor the outstanding individuals, organizations, and technologies that define excellence in bioprocessing. Socialize, dine, and laugh with friends, colleagues, and award finalists. Experience the excitement of the ceremony, then sit back, laugh, and enjoy as we poke a little fun – at ourselves!

Are you nominated?Go to www.bioprocessintl.com/awards and submit your nomination today! Space is limited, so make sure to make your reservation for the award ceremony while registering for the conference. (Separate registration and fee required)

RECOGNIZING EXCELLENCE IN BIOPROCESSING

WOMEN'S EXECUTIVE LEADERSHIP DINNER

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Women in positons of senior leadership within life sciences have truly completed an awesome feat in a male dominated space. At this year’s Women’s Executive Leadership Dinner, we honor these women by recognizing their accomplishments across various stages of the life science ecosystem. Join us for an inspiring and insightful discussion over dinner as executives share their journeys of rising to the ranks of senior leadership in life sciences. Learn how to find the right mentor for your desired career path. You don’t want to miss out on this opportunity to engage with women that are breaking barriers and taking life science to heightened levels of success.

EXPOSITION & EVENT ACTIVITIES

WED, OCT. 5TH | 7:00 pm - 9:00 pm

WED, OCT. 5TH | 7:00 pm - 9:30 pm

Hosted & Organized By

Sponsored By

PARTY IN THE PARKTHURS, OCT. 6TH | 6:00 pm - 10:00 pm

For full details regarding the conference venue, hotel, cancellation and substitution policy, visit www.IBCLifeSciences.com/BPI

Academic/Government Rates are AvailableFull-time employees of a government organization, university and university-affiliated hospital are eligible to take advantage of up to 40% savings off industry rates. Visit our website for more details and academic/government pricing

Industry Rates Save up to $600by June 24, 2016

Save up to $400by July 29, 2016

Save up to $200by Sept. 2, 2016

Standard Rate After Sept. 2, 2016

4-Day Pass: Pre-Conference Symposium (Tues) + 3-Day Main Conference (Wed-Fri) $2,699 $2,899 $3,099 $3,299

4-Day Access: 2-Day Training Course (Wed-Fri) + 2-Day Main Conference (Thurs-Fri) $2,699 $2,899 $3,099 $3,299

3-Day Access: Main Conference (Wed-Fri) $1,999 $2,199 $2,399 $2,599

2-Day Training Course Only (Tues-Wed) $1,599 $1,599 $1,799 $1,999

Group Rates (Send 4 or more) Save up to $600by June 24, 2016

Save up to $400by July 29, 2016

Save up to $200by Sept. 2, 2016

Standard Rate After Sept. 2, 2016

4-Day Pass: Pre-Conference Symposium (Tues) + 3-Day Main Conference (Wed-Fri) $2,299 per person $2,499 per person $2,699 per person $2,899 per person

4-Day Access: 2-Day Training Course (Wed-Fri) + 2-Day Main Conference (Thurs-Fri) $2,299 per person $2,499 per person $2,699 per person $2,899 per person

3-Day Access: Main Conference (Wed-Fri) $1,799 per person $1,999 per person $2,199 per person $2,399 per person

Hotel Accommodations:Aloft Boston Seaport401-403 D Street, Boston, MA 02210Central Reservations: (877) 462-5638Reservations Direct: (617) 530-1600

Special Room Rate:$349/night plus tax

When calling Reference: Boston Biotech WeekWeb link: www.starwoodmeeting.com/events/start.action?id=1601185856&key=3B2CF596

Element391-395 D Street, Boston, MA 02210Central Reservations: (877) 782-0151Reservations Direct: (617) 530-1700


When calling Reference: Boston Biotech WeekWeb link: www.starwoodmeeting.com/events/start.action?id=1601185859&key=24EE6A2A

Boston Park Plaza50 Park Plaza at Arlington Street, Boston, MA 02116Central Reservations: (800) 225-2008Reservations Direct: (617)-426-2000


When calling Reference Code: Biotech WeekWeb link: bostonparkplaza.reztrip.com/rt/ext/promoRate?property=100&mode=b&pm=true&sr=128406&vr=3

Omni Parker House60 School Street, Boston, MA 02108Central Reservations: (800) 843-6664Reservations Direct: (617) 227-8600


When calling Reference Code: Biotech WeekWeb link: www.omnihotels.com/hotels/boston-parker-house/meetings/biotech-week-boston

TRAIN YOUR TEAM AT BPI AND SAVE

With 225+ speaker presentations, 100+ scientific posters, 160+ exhibitors and 1700+ attendees to meet onsite, consider sending your whole team to BPI. Register your team of 4+ to receive an additional $400 savings/person off the current industry rate. Secure your team’s place today by contacting GROUP SALES MANAGER Brian Schiff at [email protected] or 646-895-7444.

PRESENT A POSTER TO SHOWCASE YOUR COMPANY’S LATEST RESEARCH

Conference Venue:Boston Convention and Exhibition Center415 Summer St., Boston, MA 02210Phone: 617-954-2000web: http://massconvention.com/about-us/contact-us/boston-convention-exhibition-center

Any registered attendee may present a poster for display inside the Exposition at BPI. Presenting a poster is a great way to share your company’s latest research with the global bioprocessing industry. Submit your poster abstract online by September 2, 2016.

Poster Fee: $125 for Industry, Complimentary for Academic/Government

WAYS TO REGISTER

EASIEST:www.IBCLifeSciences.com/BPI

CALL800.390.4078 or +1.941.554.35003 EMAIL

[email protected]

Early Registration & Group Discounts Available: www.IBCLifeSciences.com/BPI

Documents

BioProcess International Conference & Expositionmicrosite.sartorius.com/fileadmin/newsletter/france/PDF/Issue_8/...BioProcess International Conference & Exposition The largest bioprocessing