9th Workshop on Monoclonal Antibodies

20-21 September 2016 Radisson Blue es. Hotel

Rome | Italy

The Parenteral Drug Association presents:

2016 PDA Europe 9th Workshop on Monoclonal Antibodies

pda.org/EU/MAB2016

Ensuring mAbs’ Quality – Current Considerations for Control Strategy Design

22 September From Gene to Product – Tailormade Strategies for High Level Expression of Biologicals

22 September Elastomers

22-23 September CMC Regulatory Compliance for Biopharmaceuticals

22-23 September Extractables and Leachables

22-23 September Introduction to Aseptic Processing Principles

22-23 September The Metrics of Process Monitoring & Understanding the Risks of Variation

19 Sept Pre-Conference

Workshop Smart Devices for Improved Clinical

Outcomes- Enhancing Patient

Engagement through Digital Technologies -

https://pda.org/EU/MAB2016

2 https://pda.org/EU/MAB2016

PRE-CONFERENCE WORKSHOP

Smart Devices for Improved Clinical Outcomes– Enhancing Patient Engagement through Digital Technologies –

Overview

The aim of this workshop is to explore and discuss how the application of smart and connected devices and associated digital services can improve disease management through better use of existing medication as well as support the development of new treatments. These innovative approaches will be of interest to anyone involved in functions such as clinical, pharmaceutical and container development, as well as business development and marketing.

Workshop Committee

Jonathan Oakley, Team Consulting, Co-Chair

Iain Simpson, Cambridge Consultants, Co-Chair

Markus Bauss, SHL-CONNECT

Andy Fry, Team Consulting

Vangelis Papagrigoriou, Cambridge Consultants

Andrew Pocock, Team Consulting

Georg Roessling, PDA Europe

3https://pda.org/EU/MAB2016

WORKSHOP AGENDA

6 September 2016

Monday, 19 September 2016 9:00 – 18:00

9:00 Welcome and Introduction Georg Roessling, PDA EuropeJonathan Oakley, Team Consulting, Co-Chair,Iain Simpson, Cambridge Consultants, Co-Chair

9:10 Introduction & Overview Jonathan Oakley, Team Consulting

Session 1 Patient Experience

9:30 Patient-led Design in Healthcare Solutions with Parenteral Drug Devices

Mark Lightowler, phorix limited

10:00 Device Design to Drive Patient Adherence and Engagement Eric Chanie, Merck Serono

10:30 Q&A, Discussion

10:45 Coffee Break

Session 2: Patient / Device Interface

11:00 Technologies for Smart Devices Markus Bauss, SHL-CONNECT

11:30 Smart Devices for Improved Clinical Outcomes Paul Upham, Genentech

12:00 From Product to Service-Led Innovation – Applying Digital Services to the Pharma Sector

Tim Murdoch, Cambridge Consultants

12:30 Q & A, Discussion

13:00 Lunch Break

Session 3: Technologies & Developments

14:00 Development Process for a ‘Smart’ Drug Delivery Device Lior Shtram, Flextronics

14:30 Towards a New Generation of Outcome Measures based on Mobile Accelerometry

Martin Daumer, SLCMSR, Technical University of Munich

15:00 Wearables in Clinical Trials Bill Byram, Quintiles

15:30 Q & A, Discussion

16:00 Coffee Break

Session 4: Getting to Market: Regulatory & Technical Aspects

16:30 Regulatory Implications German & Italian Regulators invited

17:00 Panel DiscussionWhat is the future of digital healthcare technology, and what are the drivers?

Moderators:Jonathan Oakley, Team ConsultingIain Simpson, Cambridge Consultants

17:45 Summary of Workshop

18:00 End of Workshop


LETTER FROM THE CO-CHAIRS

Dear Friends, Colleagues, Collaborators and Peers,

Three decades after the licensure of the first monoclonal antibody, interest remains strong in this product class. An estimated 300 compounds are currently in various stages of clinical development for treatment of cancers, inflammatory and autoimmune diseases and other disorders. The intense focus on monoclonal antibodies has in turn driven significant developments in the chemistry, manufacturing and control aspects associated with com-mercial production. Years of accumulated process knowledge, platform approaches and application of QbD have enabled, for example, design spaces and modular claims for adventitious agent clearance and even elimination of routine testing for certain impurity types. Despite these achievements, changes in regulations and advances in analytical and computational technology will continually drive the need to re-examine existing practices and identify opportunities for improvements.

Ensuring the quality of monoclonal antibodies through appropriately designed control strategies clearly remains an area of focus for manufacturers and regulators alike. For this reason, the planning committee has selected this topic as the theme of this year’s workshop. The objective of the workshop is to examine the current state-of-the-art for process development of monoclonal antibodies and explore technologies that will influence new CM&C approaches.

Through high-level presentations, case studies and panel discussions, you will learn about the latest trends, current best practices and future expectations from thought leaders in our industry.

We also plan for ample networking opportunities with a large number of exhibiting companies, fellow speakers and regulatory representatives. A networking event on Tuesday evening, 20 September will provide a chance to relax with your colleagues after a full day of learning and professional exchange.

In addition to the two-day conference, we are proud to offer you a large selection of post-conference training courses. Please refer to the event brochure for more details.

On behalf of the program planning committee and PDA, we are pleased to invite you to the PDA Europe Monoclonal Antibody Workshop “Ensuring mAbs’ Quality – Current Considerations for Control Strategy Design“ in Rome!

Sincerely

1 2 3 4

5 6 7 8

9 10 11 12

S CIENTIF I C PR O G R A M PL A NNIN G CO MMIT T EE

1 Ursula Busse, Novartis, Conference Co-Chair2 Francesca Luciani, ISS, Conference Co-Chair3 Michael De Felippis, Eli Lilly4 Juan Gimenez, Genentech5 Steffen Gross, Paul Ehrlich Institute6 Ralf Hess, Inresa7 Ilona Reischl, AGES8 Ben P. Thompson, GSK9 Martijn van der Plas, Medicines Evaluation Board10 Rich Levy, PDA11 Sylvia Becker, PDA Europe12 Georg Roessling, PDA Europe

Ursula Busse, Novartis, Conference Co-ChairFrancesca Luciani, ISS, Conference Co-Chair


CONFERENCE AGENDA6 September 2016

Tuesday, 20 September 20169:00 Welcome and Introduction Georg Roessling, PDA Europe

Ursula Busse, Chair, Novartis

Session 1: Regulatory Developments:Recent Trends & Updates

Moderator: Martijn van der Plas, CBG-MEB

The regulatory landscape is continuously evolving; and the ongoing developments regarding lifecycle management bear the promise that regulatory expectations are being streamlined. Furthermore, important progress has been made by the publication of the guideline on process validation of biologically active substances, whilst other fields are moving forward too. This session will present and summarize some of the important current conversations.

9:10 Regulatory and Scientific Trends for Monoclonal Antibodies – An Observation from the EMA

Veronika Jekerle, EMA BWP

9:45 Immunogenicity & Biosimilar Assessment Carlo Pini, ISS, National Center for Immuno- biologicals Research and Evaluation, EMA BWP

10:15 Coffee Break, Poster Session & Exhibition

10:45 ICH Q12, Control Strategy & Lifecycle Management Markus Goese, Roche

11:15 Process Validation Brigitte Brake, BfArM, Federal Institute for Drugs and Medical Devices

11:45 Manufacturing, Analytical and Regulatory Strategies for Successful Development of ADCs

Nathan Ihle, Seattle Genetics

12:15 Q&A, Panel Discussion

13:00 Lunch Break, Poster Session & Exhibition

Session 2: Technological Innovations in Combination Products

Moderator: Juan Gimenez, Genentech

This session addresses regulatory and technical aspects of combination product development, from Human Factors Engineering to innovative approaches for establishing compliant products according to combination-product regulation. Additionally, an overview will be given on how electronics can be implemented into new devices, and a summary of the “Smart Devices Workshop” from previous day will be presented.

14:00 Summary of Smart Devices Workshop Markus Bauss, SHL-Connect

14:30 A Systemic Approach to Delivering Innovation to Combination Product Development

Daniel Latham, Novartis

15:00 Human Factor Engineering Requirements for Drug Delivery Devices

Lee Wood, MedHF




CONFERENCE AGENDA

Session 3: Particles and Immunogenicity Moderator: Ursula Busse, Novartis

Sterile injectable products need to be produced to standards of quality, purity, and sterility that include being essentially free of extraneous matter such as particles. Despite guidance in producing product that is “essentially free” of particles, manufacturing such product is very challenging. In addition, limited data exists on the potential risk of administering particles to patients. The exception are subvisible (<10 µm) protein aggregates that were shown to solicit immune responses in both preclinical and clinical studies. This session will cover the medical risk of particles in injectable biopharmaceuticals. It will address characterization, control, current inspection methods and acceptance criteria for particulate matter in protein based drug products. The session will conclude with a regulator’s perspective on quality attributes related to immunogenicity.

16:15 Particles and their Impact (not just immunogenicity) John Ayres, Eli Lilly

16:45 Biophysical Characterization of Aggregates and Particles in Biopharmaceuticals

Andrea Hawe, Coriolis-Pharma

17:15 Particle Control in Biotech Injectable Products Hanns-Christian Mahler, Lonza

17:45 Quality Attributes Impacting Immunogenicity of Therapeutic Proteins

Steffen Gross, PEI

18:15 Q & A, Panel Discussion

18:45 End of Day 1 & Networking Reception

The Parenteral Drug Association invites you to join our

Networking Reception


CONFERENCE AGENDA

Wednesday, 21 September 2016Session 4: Emerging Trends for Process

Related Impurity ControlModerator: Michael De Felippis,

Eli Lilly

The successful commercialization of a number of therapeutic monoclonal antibodies has facilitated application of many common strategies to manufacturing and quality assessment. In the case of process-related impurity control, improvements in raw material quality and separation science, years of accumulated process knowledge, platform approaches and application of QbD has enabled, for example, design spaces and modular claims for adventitious agent clearance and even elimination of routine testing for certain impurity types. Despite these achievements, changes in regulations and advances in analytical and computational technology will continually drive the need to re-examine existing practices and identify opportunities for improvements. This session explores emerging trends in the design of control strategies for process-related impurities with a focus on adventitious agents and host cell proteins.

8:30 Next Generation Sequencing (NGS) for Adventitious Agent Testing Paul Duncan, Merck Research Laboratories

9:00 Alternatives to Detergents for Viral Inactivation Implications of Annex XIV

Marie Murphy, Eli Lilly


10:00 Computational Approaches to Assessing Safety of Host Cell Proteins

Anne S. De Groot, EpiVax

10:30 LC-MS Proteomics Profiling of Host Cell Proteins Ingo Lindner, Roche

11:00 Process Monitoring Mary Cromwell, Genentech


12:00 Lunch Break, Poster Session & Exhibition

Session 5: Statistical Approaches Moderator: Francesca Luciani, ISS

The use of statistics in the CMC area for complex biologics’ manufacturing processes with inherently variable outputs is still a challenge for both industry and regulators. This session addresses the use of statistical tools in the CMC area from a technical and regulatory perspective, including case studies. The evolution and application of continued process verification to the mAb drug substance manufacturing process will be discussed, as well as potential opportunities to employ statistical tools to examine data from a process control and capability perspective. Process monitoring metrics will be presented with reference to QbD and the a-Mab case study. Progress in the context of statistics and biosimilarity will be outlined and potential implications for comparability exercises will be discussed with regulators and industry representatives.

13:00 Statistical Tools in CMC Development Thomas Stangler, Sandoz

13:30 Lifecycle Management and Continued Process Verification Cillian McCabe, Eli Lilly

14:00 The a-Mab Case Study, QbD and Process Monitoring Metrics Jason Orloff, PharmStat




CONFERENCE AGENDA

Session 6: Real Time Release and Control Strategy in the Production of Monoclonal Antibodies

Moderator: Rich Levy, PDA

As the biotechnology industry is working out the practicalities of implementing RTR in existing and new manufacturing processes, the majority of the anticipated benefits remain unfulfilled. Many technical questions remain regarding PAT including instrumentation, conducting in-line or on-line tests, data collection and analysis. Global regulatory authorities’ expectations are becoming clearer through recent guidance, but there is still a need for more clarity on how to introduce RTR into regulatory submissions, such as the common technical document, as well as how to implement RTR measurement systems in existing approved and new manufacturing processes.

15:30 Implementing “Real Time Release Testing” for Biologics Barry Cherney, Amgen

16:00 Strategic Vision for Process Control and Parametric Release of Monoclonals

Isabel Zwart, Biogen


17:00 Closing Remarks & Farewell

PDA Europe supports the children's hospice „Sonnenhof”

The Sonnenhof Hospice, located near PDA’s office in Berlin, offers support and assistance to families with children suffering from incurable and/or debilitating diseases.

At Sonnenhof, children, together with their families, can spend the time they have left as they wish and find some relief from their suffering.

Instead of purchasing expensive gifts for the conference speakers, PDA has decided to donate this amount to the Sonnenhof Hospice. You can also contribute and help us increase the amount, it is easy: buy a package of chewing gums at the registration desk.

THANK YOU!

To know more about the Sonnenhof Hospice, please visit www.bjoern-schulz-stiftung.de

SONNENHOF

SONNENHOF

SONNENHOF

Logo Sonnenhof - Farbwerte:Blau = C 100%/ M 30%/ Y 0%/ K 0%Gelb = C 0%/ M 25%/ Y 95%/ K 0%


V E N U ERadisson Blue es. HotelVia Filippo Turati 171 00185 RomeTel : + 39 06 444 841Mail: [email protected] https://goo.gl/W8UQbQ

CO NTAC T I N FO R M ATI O NConference Inquiries Melanie Decker Director Events & Exhibitions [email protected]

Conference Program Inquiries Sylvia Becker Manager Programs & Events [email protected]

Registration & Customer Care Tel: +49 30 4365508-10 [email protected]

Education Program Inquiries Elke von Laufenberg Manager Training & Education [email protected]

Exhibition/Sponsorship Inquiries Creixell Espilla-Gilart Manager Exhibition & Sponsorship [email protected]

CO N F E R E N C E R EG I S TR ATI O N H O U R SMonday, 19 September, 8:00- 16:00Tuesday, 20 September: 7:30 – 17:30

CO U R S E R EG I S TR ATI O N H O U R SThursday, 22 September: 7:30 – 17:30Friday, 23 September: 7:30 – 10:00

TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.

G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66

S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your

needs with your registration form. Specific questions can be directed to [email protected].

INFORMATION

Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lufthansa.com/event-booking_en and enter the access code DEZZYGG in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.

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D I R EC TI O N S

© Google For directions click

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PDA Education offers courses that are developed and

taught by experts. They are uniquely targeted to professionals involved in the development and manufacture of quality pharmaceutical and biopharmaceutical products.

Facts that Make a DifferenceUp-to date training courses and workshops taught by internatio-nally renowned instructors

Customized in-house training courses and workshops available

Wide range of training courses with direct hands-on experience to drive expertise, awareness, and innovation

Training & Education Program


The Parenteral Drug Association presents...

22 September 2016 ElastomersOne-Day Training Course

22 September 2016 From Gene to Product – Tailormade Strategies for High Level Expression of BiologicalsOne-Day Training Course

22-23 September 2016CMC Regulatory Compliance for BiopharmaceuticalsTwo-Day Training Course

22-23 September 2016Introduction to Aseptic Processing PrinciplesTwo-Day Training Course

22-23 September 2016The Metrics of Process Monitoring & Understanding the Risks of VariationTwo-Day Training Course

22-23 September 2016 Extractables and Leachables Two-Day Workshop


ElastomersOverview Among others the Agenda will cover the following topics:

• Elastomeric Compounds: Composition• Manufacturing Process for Elastomeric Closures• Extractables and Leachables• Particles Reduction during Closure Processing• Ready-for-Sterilization and Ready-To-Use Closures• Regulatory Requirements for Elastomeric Closures

Learning Objectives: • Understand the origin of Extractables and Leachables from elastomeric closures• Learn about the potential impact of component sterilization on closure properties• Understand past and upcoming regulatory changes for elastomeric closures• Learn about the effect of closure washing on visible particle reduction• Inform yourself on possibilities and limitations in closure design• Learn about the advantages of Ready-for-Sterilization and Ready-To-Use closures

Who Should Attend Scientific Officers, Operating Officers, Directors, Principal Scientists in

• Packaging• Drug Product Manufacturing• Product Design• Technical Support• Drug Product Process Development

• Drug Development, Design & Delivery• Clinical Trial Material Supply• Process Development• Quality Assurance Compliance and Audit

Workshop Leader

Renaud Janssen, Ph.D. , Senior Manager Global Scientific Affairs, Datwyler

Renaud Janssen graduated as a chemical engineer from Leuven University, Belgium. In 1988 he joined Helvoet Pharma, now Datwyler Sealing Solutions, in Belgium where he has been holding various positions in R&D, Quality and Technical Support on local and global level. Currently Renaud is Senior Manager Global Scientific Affairs for the Healthcare segments of Datwyler Sealing Solutions. Renaud serves on several standardization and pharmacopoeial committees.

Trainers

Bram Jongen, Head of Material Development, DatwylerAndreas Linz, Sales Director, AtecReinhold Zimmermann, Vice President Continous Improvement, West

All participants are invited to submit their elastomer related questions,

issues and practical problems until 8 September 2016

to PDA Europe training department [email protected]

All these and further questions will be addressed during this interactive

workshop.

ONE-DAY WORKSHOP


Thursday, 22 September 2016 9:00 - 18:009:00 Introduction

Presentation and clustering of submitted student questions, issues, and practical problems

Renaud Janssen, Datwyler

10:00 What are the consequences of elastomeric compound selection for Extractables & Leachables?• Composition of elastomeric closure compounds• Clean extractable profiles as key attribute of compound development• Translation of application requirements to closure compositions

Bram Jongen, Datwyler

10:45 Coffee Break

11:15 Which closure properties might be influenced by different sterilization methods?• Extractables & Leachables, mechanical characteristics,

functional performance• Steam versus gamma irradiation

Reinhold Zimmermann, West

11:35 How are elastomeric closures related to ICH Q3D ‘Elemental Impurities’ and to pharmacopoeia ?• Overview of pharmacopoeial requirements • Elastomeric closures in relation to ‘Elemental Impurities’ regulations• DMF’s for elastomeric closures


12:20 What are the main aspects to consider for recommending closures?• Material, drug compatibility, drug delivery, drug administration etc.


12:45 Lunch Break

13:45 How can particle reduction be qualified through stopper washing ?

Andreas Linz, Atec

14:30 Which are the specific considerations pharmaceutical packaging development has to take into account when designing elastomeric components?• An A-Z pictorial description of the closure manufacturing process

– Standard manufacturing – Coated closures – Lined seals

Bram Jongen, Datwyler

15:15 Coffee Break

15:45 Which impact do stopper elastomer material and closure processing steps have on residual moisture in the closure and in the freeze dried product over long term storage?• Steam sterilization• Drying conditions


16:15 What are the advantages of RfS and RTU closures ?• Cost savings related to RfS and RTU elastomeric closures• Validation activities related to RfS and RTU closures• Market evaluation of RfS and RTU closures


17:00 Open Discussion of student questions, issues, and practical problems with elastomers

18:00 End of Workshop

WORKSHOP AGENDA


ONE-DAY TRAINING COURSE

From Gene to Product –Tailormade Strategies for High Level Expression of Biologicals

Overview Biologicals, well known proteins with a diversity of distinct bioactivity, are involved in many biological processes. Nearly identical to naturally produced in the human body, these biomolecules play an active role as targets for pharmaceutical and diagnostic applications. However, the realization of future appli-cations in the medical field requires tailor made strategies for the in vitro production of recombinant proteins. The synthetic access to these “artificial complex compounds” is still challenging. Following the mission statement from “gene to product” this lecture will provide an overview on the development of efficient strategies for high level expression of biologically active molecules.

Learning Objectives: Upon completion of this course, you will be able to:• Explain the routes from genes to native proteins • Apply the routes from genes to recombinant proteins• Evaluate the differences between eukaryotic and prokaryotic expression systems • Understand the importance of profound knowledge of complex proteins and underlying challenges for

heterologous production of biologicals • Explain tailor-made strategies for efficient production of biologically active compounds

FacultyLeonie Engels, PhDLeonie Engels was research associate at the Institute of Biotechnology/Laboratory for Biomaterials and Helmholtz-In-stitute for Biomedical Engineering RWTH Aachen from 2005-2015. In over 10 years she gained a profound knowledge in cloning and expression of genes in microbial host organisms and in DNA/protein sequence analysis. Her broad ex-perience in identification, production, purification and characterization of novel enzymes for the in vitro synthesis of natural and modified glycans is attested in seven publications and one granted patent. Her work was funded by the German “Federal Ministery for Education and Research” (BMBF) and the DECHEMA Max Buchner Foundation. As PhD

student she joined Genentech Inc., South San Francisco, USA (Department: Early stage cell culture) for an internship in 2013. Leonie Engels obtained her M.S in Biology and her PhD degree from the RWTH Aachen University.

Who Should Attend The course will focus on individuals that are involved in the biopharmaceutical area. This includes the following functions within pharmaceutical or biotech industry including drug substance manufacturers.

• Research & Process Development• Analytical Development• Manufacturing & Technical Operations• Engineering• Quality Control• Quality Assurance• Regulatory Affairs• Supply Chain Management• Project Management

THE COURSE IS DEDICATED TO THE FOLLOWING SPECIFIC JOB FUNCTIONS:

• CMC Team Leaders• Managers/Supervisors in manufacturing and QC/QA• Researchers• Technicians• Regulatory Affairs Specialists• Supply Chain Managers• Project Managers


6 September 2016

Thursday, 22 September 2016 9:00 – 18:00

9:00 Welcome and Introduction

9:10 The Revolution of Molecular Biotechnology:

• History of molecular biotechnology• From genes to native proteins• Basics of DNA recombination – Restriction endonucleases – Plasmid vectors – Transformation and selection – Sequencing

10:30 Coffee Break

11:00 Gene Expression in Prokaryotes

• Selection of promotors and expression vectors• Fusion proteins• Loss of expression• Transport and localization• Advantages and limitations

12:30 Lunch Break

13:30 Gene Expression in Eukaryotes

• In yeast • In insect cells• In transgenic plants• In mammalian cells • Advantages and limitations

15:00 Coffee Break

15:30 Tailormade Solutions for Efficient Production of Recombinant Proteins:

• Bioengineering operations • Site directed mutagenesis and protein design• Conclusions• Questions and answers

18:00 End of Training Course

TRAINING COURSE AGENDA


CMC Regulatory Compliance for BiopharmaceuticalsOverview

Biopharmaceuticals are being developed by many companies whose Chemistry, Manufac-turing & Control (CMC) teams have varying degrees of familiarity or experience with the regu-latory requirements for these challenging products. Companies clearly understand the critical importance of their human clinical study strategy, but frequently, the development of a strategy for Chemistry, Manufacturing & Controls (CMC) is an afterthought. Add the frequent lack of CMC regulatory compliance experience in some companies, coupled with the complexity of the biological manufacturing processes and products, and this can be a recipe for disaster.

This course will provide insights and practical guidance for the CMC teams to develop an acceptable cost-effective CMC regulatory compliance strategy for biopharmaceuticals from early clinical stage development through market approval. The course emphasis will include FDA, EMA and ICH guidance.

Who Should Attend This course is designed specifically for those involved in or interested in the manufacture and control and CMC regulatory issues of biopharmaceuticals, including Senior Management, Directors and Managers/Supervisors, QA/QC, Regulatory Affairs, Manufacturing and Process Development personnel.

Learning Objectives: Upon completion of this course, you will be able to:• Explain the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuti-

cals to move your products through clinical development into the marketplace• Explain the importance and underlying principles for CMC regulatory compliance of biopharmaceuticals and

how this leads regulatory agencies to have different CMC regulatory requirements for biotech products com-pared to pharmaceuticals of chemical origin.

FacultyJohn Geigert, PhD, BioPharmaceutical QualityJohn Geigert is President of BioPharmaceutical Quality Solutions, which for the last 12 years has specialized in provid-ing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. He has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. He has held senior management positions as Vice President of Quality at both IDEC Pharmaceuticals Corporation in San Diego and Immunex Corporation in Seattle, and he was Director of Product Development at Cetus Corporation in Berkeley. At these companies, he helped lead the CMC efforts to obtain regulatory approvals for 6 biopharmaceutical products now commercially available in the U.S.

and in Europe. John Geigert has served on the PDA Board of Directors, current co-chairs the PDA Biotech Advisory Board, and has served as an expert member of the USP Biotechnology Committee. He is the author of the book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics 2nd Edition, and has written extensively for RAPS Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series)), Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series). John Geigert obtained his B.S. in Chemistry from Washington State University and his Ph.D. degree in Organic/Analytical Chemistry from Colorado State University.

TWO-DAY TRAINING COURSE


6 September 2016


9:00 Welcome and Introduction

CMC Regulatory Challenges for Biopharmaceuticals are Different

9:10 – Painting the Terminology Landscape: Biologic, specified biologic, biopharmaceutical, biosimilar, CBER, CDER, EMA, ...

10:30 Coffee Break

11:00 – Understanding the CMC Differences of Biopharmaceutical Regulation between FDA and EMA– Biopharmaceuticals are not Chemical Drugs – Regulatory Compliance Consequences of the four Major CMC Differences

12:30 Lunch Break

How to Develop an Effective Corporate CMC Risk-Managed Control Strategy for Biopharmaceuticals

13:30 – Three Major Forces that Shape the CMC Regulatory Compliance Strategy of all Biopharmaceuticals– Five Key Elements of an Effective Corporate CMC Regulatory Compliant Strategy

15:00 Coffee Break

15:30 – Impact of the Quality by Design (QbD) on Biopharmaceutical CMC Strategy– Necessity of a Clinical Phase - Appropriate CMC Regulatory Compliance Strategy

17:00 End of Day 1

Friday, 23 September 2016 9:00 – 17:00

Applying a CMC Risk-Managed Control Strategy to the Biopharmaceutical Manufacturing Process

09:00 – Four Myths about Biopharmaceutical Starting Material – the Master Cell Bank– Necessity of Confirming Clonality and Genetic Stability

10:30 Coffee Break

– Importance and Limitations of small-scale Studies for Biopharmaceuticals

– Clinical Phase - Appropriate Control of the Biopharmaceutical Manufacturing Process

– Formulation and Container-Closure Challenges for Biopharmaceuticals – Impact of Components on the Biopharmaceutical (e.g., protein aggregation) and Impact of the Biopharmaceutical on Components (e.g., glass delamination)

12:30 Lunch Break

Challenge of Managing Manufacturing Process Changes and Demonstrating Biologic Product Comparability – Not an Easy Task!

13:30 – Need for Risk-based, Sequential and Clinical Phase - Appropriate Comparability Studies – Demonstrating Biologic Product Comparability – Justifying CMC Differences

15:00 Coffee Break

15:30 – “Comparability Protocol” and “Post Approval Change Management Protocol”

– Extreme Comparability of Biosimilars: Limitations of CMC Comparison, Fingerprinting – CMC Biosimilarity Successes and Failures




Introduction to Aseptic Processing PrinciplesOverview

This course is intended to provide individuals with an understanding of the fundamental principles governing aseptic processing. The course will cover the systems associated with aseptic processing and how they work together to help ensure a sterile product.

The Key Topics are:

• Facility/Equipment/Process Design• Environmental Monitoring• Gowning/Aseptic Technique• Sterilization• Cleaning and Disinfection• Process Simulations (Media Fills)• Recent Regulatory Activity

Who Should Attend This course is ideal for those who are either new to the industry or new to aseptic processing. Participants from disciplines such as mechanics, HVAC technicians, cleaning and disinfection personnel, and microbiology techni-cians will also benefit from this course even if they are minimally involved in the aseptic manufacture of drugs, but need to understand the systems associated with it.

Learning Objectives: Upon completion of this course you will• Be able to describe some of the critical elements (“strands of the rope”) associated with aseptic processing• Be able to discuss basic concepts of cleanroom operation and monitoring• Have an understanding of the current regulatory concerns and industry interpretations of the regulations

FacultyCarol Lampe, ConsultantCarol Lampe is currently an independent consultant. She retired from Baxter Healthcare’s Corporate Sterility Assurance Group, where she worked for over 30 years and was a subject matter expert on aseptic processing. She was the co chair for TR#62 on “Recommended Practices for Manual Aseptic Processes”, which was issued in 2013, and is the trainer for a PDA course on the subject. She served on the PDA task force for the original and revised (2013) TR#22 on process simulation testing of aseptically produced products. She was a member of the PQRI Committee that evaluated the FDA draft guidance on aseptic processing She was on the PDA training team, who along with the FDA, provided training and

interpretation of the 2004 FDA guidance to industry on aseptic processing. She currently is a member of the training cadre for course work relating to fundamentals of aseptic processing, cleanroom fundamentals, support sterilization, and cleanroom behavior.



Thursday, 22 Sept 2016 9:00 – 18:00

9:00 Introductions/Scope• List the “strands of the rope”• Describe the importance of each component

of aseptic processing• Discuss how the components of aseptic processing

are interrelated

Facility Design/HEPA Filters/Differences between Isolators and Conventional Processing• Identify key components of facility design

and controls• Define regulatory requirements of critical

and clean area control parameters• Discuss HEPA filter construction/function/testing• Identify differences between aseptic processing in

isolators and conventional lines

Coffee Break

Velocity Testing/Airflow Studies – Working in Unidirectional Flow• Describe concepts of airflow and “first air”• Analyze videos of operators working in

unidirectional airflow• Understand risk of product contamination

when not following first air principles

Lunch Break

Basic Microbiology• Describe qualities and types of microorganisms• Describe modes of microorganism transport• List growth requirements and sources• Explain methods and importance of identification

Coffee Break

Cleaning and Disinfection/Bio-Decontamination• List appropriate application methods• Describe the importance of cleaning

and disinfection• Understand the basis of chemical selection,

use and application• Detail the proper order of cleaning• Describe bio-decontamination methods

for isolator/barrier systems

Gowning, Personnel Qualification and Aseptic Technique and Cleanroom Behavior• Explain acceptable personnel behavior• Discuss what should be included in personnel

qualification program• Describe why training and qualification

minimize contamination

18:00 End of Day 1

6 September 2016

Friday, 23 Sept 2016 9:00 – 17:00

9:00 Environmental Monitoring• Environmental monitoring techniques for

various applications. • Discuss choosing monitoring locations.• Discuss alert and action limits.

Coffee Break

CIP/SIP/Depyrogenation• Describe how CIP and SIP can lower risk of

contamination and minimize manual interventions• Identify key CIP/SIP process steps and types of

equipment that can be CIP/SIP’d• Discuss principles of depyrogenation

and its importance to injectable products

Lunch Break

Aseptic Processing Simulation Studies (Media Fills)• Review background and objective of APS• Review elements of study design

Coffee Break

Regulatory Trends• Recent trends in regulatory citations





The Metrics of Process Monitoring & Understanding the Risks of VariationOverview

The truth of product quality is hidden in the data. Statistical methods provide objective evidence in meeting goals of compliance and performance. This course provides guidance to identify and use statistical process monitoring methods to validate, calibrate, maintain, and troubleshoot. The course will convey the appropriate use of statistical methods at a level and in a way that will be easily understood. Hands-on experience using a syringe filler will generate data to mea-sure, quantify, and compare sources of variation. Common methods such as comparing sample summary parameters, confidence intervals vs tolerance intervals, and control charts will be de-scribed, typical applications will be identified and pros and cons of each method will be exam-ined. Examples of each method will be described to show how they can be used in a real-world setting. This course will utilize PDA Technical Report No. 59, Utilization of Statistical Methods for Production Monitoring as a resource.

Who Should Attend Persons involved in the following functions/disciplines will find this course of value:• Manufacturing Engineering• Process Engineering• Process Improvement

• Process Validation• Project Analysis• Quality Assurance

• Quality Control• Quality Systems• Risk Assessment

Learning Objectives: • Improve interpretation of quality

control and manufacturing data

• Detect patterns hidden in data to make right decisions

• Avoid loss of batches and money due to misinterpretation of data

• Apply the most appropriate statistical tool based on the case at hand

• Cite the regulatory references relevant to understanding, controlling and reducing process variation

• Calculate the probability of OOS within a single lot and series of lots for annual reporting

• Linking the concept of Variation to Process Validation and Continual Monitoring

FacultyJason J. Orloff, Chemical Engineer & Statistician, PharmStatJason J. Orloff, a chemical engineering applied statistician, is principal statistical consultant at PharmStat. An inter-national consultant, he specializes in applied statistics and experimental design for development, quality assurance, quality control, validation, and production under the cGXP’s. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Mr. Orloff brings twenty years of experience in pharmaceutical manu-

facturing, quality, and regulatory affairs. Areas of expertise include PAT, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Mr. Orloff is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Mr. Orloff has worked with a wide variety of companies including pharmaceuticals, parenterals, biotechnology, fine chemicals, medical devices, food, and nanotechnology. He holds a BS in Chemical Engineering from UW-Madison and an MS degree in Applied Statistics from DePaul University.


6 September 2016


9:00 Welcome Orientation: Goals & Objectives of Class

Results of pre-class survey on regulator citations and urgent topicsParametric and non-parametric statistics

10:30 Coffee Break

11:00 Instructor led discussion of student regulatory challenges linking variation to process validation ,monitoring, and improvement

Introduction of and practice with statistical tools:We will use the qualification of a syringe filler as our case study to develop basic statistical tools for general application

12:30 Lunch Break

13:30 Lessons from Syringe Filling & Measurements continued

Advanced topics in variation: Box Plots ,Confidence Intervals, and Tolerance Intervals

15:30 Coffee Break

16:00 The Muddiest Point: Participants will write the least clear or most confusing part of topics introduced Faculty will use it as feedback and to guide their talks for the remaining class

Wrap up

18:00 End of Day 1

Friday, 23 September 2016 9:00 – 16:30

09:00 Process Monitoring: The balance of Compliance vs Performance

Applying the statistical tools to create Control Charts

10:30 Coffee Break

11:00 Case studies in process monitoring: when to use a control chart

Contrasting this with the use of control charts during annual review

12:30 Lunch Break

13:30 Performing Capability Analysis and calculating the probability of OOS

Pitfalls of Process Capability Indices. Advantages of using the probability of OOS in annual review

15:00 Coffee Break

15:30 Directed Paraphrasing Exercise: The participant translates information into their own words




Extractables & LeachablesIncluding: Important Regulatory Updates – Case Study Section: Selection of Toxikons most interesting Case Studies, presented over the last 10 years!

OverviewWhen making Parenteral Drug Products, pharmaceutical companies are faced with the need to further investigate the materials that will be in contact with the drug product, either during manufacturing, in-termediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, also quality issues – i.e. for biopharmaceuticals – have become an additional concern.

This workshop will look at “Extractables & Leachables” from many different angles: Definitions, Regula-tory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral primary packaging systems, as well as for injection devices.

In addition, during the workshop, a full session will be dedicated to an in-depth update on regulations, standards and recommendations in this field (PQRI, USP, BPOG…).

Learning Objectives

Upon completion of this workshop, you will be able to:

• Explain in detail the current regulatory requirements for container / closure qualification form an E/L perspective.

• Explain the upcoming changes in regulations, standards and recom-mendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.

• Understand the materials of construction – and their composition – of container closure systems, and how they could impact the safety and quality of a parenteral drug product.

• Put together an evaluation program (review of provided documenta-tion, analytical testing) of different types of parenteral drug product container/closure systems.

• Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study.

Who Should Attend

• Pharmaceutical Packaging and Device Engineers

• Production Engineers, using SU systems

• Regulatory Affairs Officers

• Pharmaceutical R & D Managers

• Analytical Chemists, working on E/L

• Quality Assurance Officers

Faculty Piet Christiaens, PhD, Scientific Director, Toxikon Europe

Dennis Jenke, PhD, Distinguished Scientist, Baxter Healthcare

Thursday, 22 Sept 2016 9:00 – 18:00 | Friday, 23 Sept 2016 9:00 – 16:30

TWO-DAY WORKSHOP

Please note that this Training Course takes place at the

UNA Hotel RomaVia Giovanni Amendola, 57

00185 Roma, ItalyTel.: 39 0664937045Fax.:39 0664937044

www.unahotels.it


WORKSHOP AGENDA

Thursday, 22 Sept 2016 9:00 – 18:00 | Friday, 23 Sept 2016 9:00 – 16:30

Introduction on Extractables & Leachables (E/L) ▶ What is the importance of a good E/L-qualification? ▶ Historical cases of leachables, impacting the quality or the safety of a drug product ▶ Regulatory requirements (FDA, EMA…) for primary packaging ▶ Understanding the Materials, Used in the Manufacture of Pharmaceutical Containers & Closures ▶ Types of polymers – examples in medical/pharmaceutical use ▶ Understanding the composition of polymers ▶ The issues with glass in parenteral applications ▶ Analytical Techniques to Perform Extractables & Leachables Research ▶ The importance of sample preparation: the corner stone in E/L research ▶ What are the target compounds for material research ▶ How does a classification of these compounds assist in finding the right analytical technique ▶ From basic “screening” methodologies to state-of-the-art equipment

How to Set-up Extractables & Leachables Studies ▶ Selecting the right conditions for extraction ▶ How to select the right compounds to monitor in a leachable study ▶ Designing a leachable study

FULL Session on Updates of E/L- Regulations, Standards and Recommendations ▶ Pharma Packaging:

– Preview of the final PQRI Parenteral Drug Product (DPD) & ODP Chemistry group – Update on the most recent developments on the USP <661> chapters

▶ (Bio)Pharmaceutical Manufacturing – The BPOG protocol – Where is USP with the update on the USP <661.3> Plastic Manufacturing Components standard

How to Perform a Safety Evaluation – Risk Assessment on Extractables & Leachables ▶ Toxicology 101 ▶ EMA Guideline on Genotoxic Impurities ▶ ICH M7 (DNA reactive Impurities) and it’s suggested staged approach ▶ The Threshold Concept of PQRI (OINDP and PDP/ODP) ▶ Examples

Piet Christiaens, PhD, Scientific Director, Toxikon EuropePiet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-Polymers (Kra-ton Polymers). Since 2001, Piet has been Scientific Director at Toxikon Europe where he develops analytical

methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. He over-sees all laboratory operations at Toxikon Europe and is also supports the European business development team.

Lead Presenter


E/L Testing for a Small Volume Parenterals ▶ Glass Syringes: the issues with tungsten, glue residues and silicone oil and glass metals leaching ▶ The issue with rubbers: the plunger, the needle shield or the tip cap: different approaches needed? ▶ The impact of Secondary Packaging – option or necessity? ▶ Setting up Extractable & Leachable studies for a pre-filled syringe ▶ Primary Packaging for the lyophilized drug product – modus of interaction with the DP

E/L Testing for a Large Volume Parenterals ▶ The challenge in E/L testing for LVP’s. ▶ Primary Packaging for LVP’s: critical materials and components ▶ Secondary Packaging for LVP: critical points to consider

E/L Testing for Disposable and Single-Use Systems in Bioproduction ▶ How to classify the risk of different Single Use Systems in the bioproduction process? ▶ Understanding BPSA & BPOG recommendations, and how they can be implemented in

the Study Design ▶ Performing E/L studies on filters: potential approaches

Case Study Section ▶ Case study examples for Primary Packaging: pre-filled syringes, lyophilized drug product containers, Blow-

Fill-Seal applications, large volume Parenterals etc. ▶ Case study examples of the impact on Secondary Packaging: labels, printing inks, carton boxes etc. ▶ Case study examples of Single Use Systems: bags, filters, Tubing.

Dennis Jenke, PhD, Distinguished Scientist, Baxter HealthcareDennis Jenke is a Baxter Distinguished Scientist at Baxter Healthcare Corporation where he works with a team whose primary responsibility includes the assessment of material/product compatibility, specifically with re-spect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, leachables/extractables and product ingredient binding). He has published extensively in the areas of analytical chemistry, environmental science and material/solution

compatibility and serves as an expert reviewer for numerous pharmaceutical and analytical journals. He is the author of the book Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables and a contributing author to the Leachables and Extractables Handbook. Dennis is a member of industry groups whose charter is to establish best demonstrated practices in the area of material/solution compatibility.

WORKSHOP AGENDA

Pharmaceutical Microbiology

The Parenteral Drug Association presents:

2017 PDA Europe

14-15 February 2017Porto | Portugal

Mark Your Calendar

Microbiology in Pharmaceutical Manufacturing

2017 Microbiology_FP.indd 1 19.07.16 10:54


PDA Europe Conference, Exhibition, Training Courses

9th Workshop on Monoclonal Antibodies20-21 September 2016 | Rome | Italy

Your registration is only complete upon filling in and submitting both pages of this form.

1 RegistrationNo PDA membership included

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 995 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).

Discount for Exhibiting Companies

The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.

20-21 September Conference only Conference Fee net

9th Workshop on Monoclonal Antibodies PDA Member 1495Nonmember 1745

Regulatory/Academic 750

19-21 September Pre-Conference Workshop + Conference Bundle Fee net

Smart Devices for Improved Clinical Outcomes9th Workshop on Monoclonal Antibodies

PDA Member 1895Nonmember 2145

22-23 September Two-Day Training Course Training Course Fee net

CMC Regulatory Compliance for Biopharmaceuticals All Participants 1395

22 September One-Day Training Course Training Course Fee net

From Gene to Product – Tailormade Strategies for High Level Expression of Biologicals

All Participants 695

22 September One-Day Workshop Workshop Fee net

Elastomers All Participants 695


Introduction to Aseptic Processing Principles All Participants 1395

22-23 September Two-Day Workshop Workshop Fee net

Extractables and Leachables All Participants 1395

19 September Pre-Conference Workshop Workshop Fee net

Smart Devices for Improved Clinical Outcomes All Participants 795


The Metrics of Process Monitoring & Understanding the Risks of Variation All Participants 1395

All fees given in Euro, excluding VAT (22 %)

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PDA Europe Conference, Exhibition, Training Courses

9th Workshop on Monoclonal Antibodies20-21 September 2016 | Rome | Italy

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2 0 1 6 P D A E U R O P E A C T I V I T I E S & E V E N T S

europe.pda.org

General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66

Conference InformationMelanie DeckerDirector Events & ExhibitionsTel: + 49 30 [email protected]

Training Course InformationElke von LaufenbergManager Training & EducationTel: + 49 30 [email protected]

LegendIG – Interest Group MeetingTC – Training CourseWS – Workshop

19 September

20-21 September

22 September

22 September

22-23 September

22-23 September

22-23 September

22-23 September

Smart Devices for Improved Clinical Outcomes

9th Workshop on Monoclonal Antibodies

Elastomers

From Gene to Product –

Tailormade Strategies for High Level Expression of Biologicals

CMC Regulatory Compliance for Biopharmaceuticals

Extractables and Leachables

Introduction to Aseptic Processing Principles

The Metrics of Process Monitoring & Understanding the Risks of Variation

WS

WS

TC

TC

WS

TC

TC

Rome, Italy

27-28 September

29 September

29-30 September

Pharmaceutical Freeze Drying Technology | Conference

Application of a Risk-Based Approach to Freeze-Drying Processes

Development of a Freeze Drying Process

TC

WS

Strasbourg, France

5-6 October Current Challenges in Aseptic Processing, Potential Changes in

EMA / PIC / S Annex 1 Revision

WSDublin, Ireland

10 October

11-12 October

13 October

13-14 October

14 October

Schiphol Airport Site Visit & On-Site Workshop “Pharma by Road”

Pharmaceutical Cold & Supply Chain Logistics | Conference

Good Qualification Practice of Pharma Storage & Transportation

Equipment

Secure Cold Chain Practices

Supply Chain Strategies for API and Drug Product

TC

TC

TC

TC

Amsterdam,

The Netherlands

24 October

25-26 October

27-28 October

27 October

Particle Identification in Parenterals

Visual Inspection Forum

An Introduction to Visual Inspection: A Hands-on Course

Testmethoden für vorbefüllte Spritzen (PFS)

TC

TC

TC

Berlin, Germany

8-9 November Data Integrity WS Berlin, Germany

14 November

15-16 November

17 November

17-18 November

17-18 November

17-18 November

17-18 November

Managing Single- and Multi-Source Supply Chain Challenges

Outsourcing & Contract Manufacturing | Conference

Quality by Design for Biopharmaceuticals

Practical Guide for Root Cause Investigations – Methodology & Tool Kit

Outsourcing, Technology Transfer, and CMO-Client Relationships

Risk Management in Technology Transfer

Basics of Successful Auditing

TC

TC

WS

TC

TC

WS

Barcelona, Spain

24-25 November Track und Trace-Implementierung von Serialisierung TC Leipzig, Germany

2 0 1 7 P D A E U R O P E A C T I V I T I E S & E V E N T S14-15 February

Pharmaceutical Microbiology | Conference

Microbiology in Pharmaceutical ManufacturingPorto, Portugal

Subject to change For latest info: europe.pda.org Shortlist 6 September 2016

https://europe.pda.org

https://www.pda.org/pda-europe/home/

Documents

9th Workshop on Monoclonal Antibodies