BioProcess International US Westdownload.knect365lifesciences.com/2019/B19155Guide.pdfBioProcess International US West EVENT GUIDE March 11-14, 2019 Santa Clara Convention Center Santa

Agenda at a Glance . . . . . . . . . . . . . . .3General Information . . . . . . . . . . . . . . .4Sponsors . . . . . . . . . . . . . . . . . . . . . . . .6Session Room Floor Plan . . . . . . . . 10

Exhibition InformationBPI West Passport Game . . . . . . . . . .8Exhibitor List and Floor Plan . . 24, 25Poster Presentations . . . . . . . . . 27-30

Conference AgendaPre-Conference Symposia . . . . . . . 12Tuesday, March 12 . . . . . . . . . . . .14-15Wednesday, March 13 . . . . . . . . .16-17Thursday, March 14 . . . . . . . . . . .18-19

Table of Contents

BioProcessInternationalUS West

EVENT GUIDE

March 11-14, 2019Santa Clara Convention CenterSanta Clara, CA

Event Partners:

Follow us on Twitter @bioprocess365 and tweet using hash tag #BPIWEST 3

Agenda At-A-GlanceMonday, March 11, 2019 • Pre-Conference Symposia

8:50-5:00SYMPOSIUM 1:

Microbial Production (Grand Ballroom A)

SYMPOSIUM 2: Continuous and

Intensified Bioprocessing (Grand Ballroom B)

SYMPOSIUM 3: PAT and Advanced Process

Control (Grand Ballroom C)

SYMPOSIUM 4: Cell & Gene Therapy

Bioprocessing (Grand Ballroom D)

Bio-Rad Downstream Process Development

Seminar and Boehringer Ingelheim Site Tour

(8:45 am - 1:30 pm, pick up at Hyatt Regency Santa Clara)

4:30-5:00 Keynote Presentation (Mission City B4/B5) 5:00 - 6:00 Networking Reception (Hyatt Ballroom Foyer)

Tuesday, March 12, 2019 • Main Conference Exhibit Hall & Poster Viewing Hours: 9:15 am – 6:30 pm

8:00 - 9:15 PLENARY SESSION (Theater, 2nd floor)

9:55 - 12:00TRACK 1: Flexible &

Smart Facilities (Mission City B4)

TRACK 2: Early Stage Process Development

(Theater, 2nd floor)

TRACK 3: Late Stage Process Development

(Theater, 2nd floor; Combines with Track 2)

TRACK 4: Commercial Manufacturing & Beyond (Mission City B4; Combines

with Track 1)

TRACK 5: Viral Safety

(Mission City M1)

TRACK 6: Novel Technologies

Sponsored by MilliporeSigma(Mission City M2)

12:00-12:30 Technology Workshops Sponsored by Entegris (Meeting Room 204), JSR Life Sciences (Meeting Room 210), Sartorius Stedim Biotech (Meeting Room 203), FortéBio (Meeting Room 209)

12:30-1:00 Lunch n Learn Presentations Sponsored by Advanced Bioprocessing (Grand Ballroom C), Sartorius Stedim Biotech (Grand Ballroom D)

12:30-1:55 Networking Luncheon (Exhibit Hall A/B)






(Mission City B5)

TRACK 4: Commercial Manufacturing & Beyond

(Mission City M3)


(Mission City M1)

2:45 - 3:20 Scientific Track Presentations Sponsored by GE Healthcare (Mission City B4), Thermo Fisher Scientific (Theater, 2nd Floor), Asahi Kasei Bioprocess (Mission City M1), Roche ( Mission City B5)






(Mission City B5)

TRACK 4: Commercial Manufacturing &

Beyond (Mission City B4; Combines

with Track 1)

TRACK 5: Viral Safety(Mission City B5; Combines

with Track 3)

5:30 - 6:30 Networking Reception in the Poster and Exhibit Hall Co-Sponsored by GE Healthcare and MilliporeSigma

Wednesday, March 13, 2019 • Main Conference Exhibit Hall & Poster Viewing Hours: 9:15 am - 4:00 pm 7:30 - 8:00 Technology Workshops with Light Continental Breakast Sponsored by Repligen (Mission City B4)

8:00 - 9:15 PLENARY SESSION (Theater, 2nd floor)

9:55 - 11:30TRACK 1:

Bioprocessing 4.0 (Mission City B4)


(Mission City B5)


(Mission City B5; Combines with Track 2)

TRACK 4: Commercial Manufacturing & Beyond (Mission City B4; Combines

with Track 1)


(Mission City M3)

11:30 - 12:00 Technology Workshops Sponsored by Advanced Bioprocessing (Meeting Room 203), FUJIFILM Irvine Scientific (Meeting Room 210), Dyadic (Meeting Room 204), GE Healthcare (Meeting Room 209)

12:00 - 1:40 Lunch n Learn Sponsored by GE Healthcare

1:10 - 2:45TRACK 1:



(Mission City B5)


(Mission City B5; Combines with Track 2)

TRACK 4: Commercial Manufacturing & Beyond(Mission City B4: combines

with Track 1)


(Mission City M3)

TRACK 6: Emerging Scientists

Sponsored by 3M (Mission City M2)

2:45 - 3:30 Scientific Track Presentations Sponsored by Thermo Fisher Scientific (Mission City B5 ), Pall Biotech (Mission City B4), MilliporeSigma (Mission City - M3)

4:00 - 5:30TRACK 1:



(Mission City M3)

TRACK 3: Late Stage Process

Development (Mission City B5)

TRACK 4: Commercial Manufacturing & Beyond (Mission City B5: combines

with Track 3)


(Mission City B4; combines with Track 1)

TRACK 6: Emerging Scientists

Sponsored by 3M (Mission City M2)

5:30 Offsite Networking Reception (Walk Over to Levi's Stadium - Black Oak Casino Resort Club North)

Thursday, March 14, 2019 • Main Conference

8:00-9:30TRACK 1:

Single-Use Applications (Mission City B4)


(Mission City B5)


(Mission City M3)


(Mission City M3: combines with Track 3)

9:20 - 9:50 Technology Workshops Sponsored by ATUM (Meeting Room 203), Fujifilm Diosynth Biotechnologies (Meeting Room 204), Avid Bioservices (Meeting Room 209)

9:50 -11:35TRACK 1:



(Mission City B5)


(Mission City M3)

TRACK 4: Commercial Manufacturing & Beyond(Mission City M3: combines

with Track 3)

TRACK 5: Novel Technologies – Analytical Tools

(Mission City M2)Sponsored by Riffyn and Synthace

11:35-12:35 Scientific Track Presentation Sponsored by Thermo Fisher Scientific (Mission City M3)12:35-1:25 Networking Luncheon (Mission City Foyer & Ballroom)

1:25-3:00TRACK 1:



(Mission City B5)


(Mission City M3)

TRACK 4: Commercial Manufacturing & Beyond(Mission City B4; Combines

with Track 1)

4 www.BioProcessWest.com

Admission Admission is limited to persons actively engaged in biopharmaceutical process development and manufacturing . KNect365 has taken every effort to prohibit admissions to persons not engaged in this area . Children under 18 are not permitted in the Exhibit Hall under any circumstances . Badges and badge holders must be worn at all times while attending the event . Conference badges are non-transferable and lost badges will not be replaced without payment of the full conference registration fee . No exceptions .

Registration Desk Open Monday, March 11 7:30 am – 5:00 pmTuesday, March 12 7:00 am – 5:30 pmWednesday, March 13 7:00 am – 5:30 pmThursday, March 14 7:00 am – 3:00 pm

Exhibit Hall & Poster Viewing Hours Tuesday, March 12 9:15 am - 6:30 pmWednesday, March 13 9:15 am - 4:00 pm

BPI US West AppAll attendees who registered for a main conference pass receive access to the BPI US West networking app that allows you to view the full attendee list, send meeting requests/messages, and participate in our exhibitor passport prize game . You may log in at https://connect .jujama .com/BioProcess-International-US-West or by downloading the ‘KNect365’ app on your iPhone or Android app store . Need your username? Come visit us at the registration desk!

Video/Photo Consent PolicyThis conference is being filmed. When you enter this event, you may be in areas that are being filmed by video or photography. By entering the event premises, you consent to the filming, display, release, publication, exhibition or reproduction of your image and anything spoken by you to be used for news, Web casts, promotional purposes, telecasts, advertising, inclusion on Web sites, or any other purposes by KNect365 Life Sciences. You release KNect365 Life Sciences and its respective affiliates, employees and representatives, and each and all persons involved from any liability connected with such filming. You have been fully informed of your consent and release.

Mobile ChargingCharge your device in the charging zone in the exhibit hall. Mobile charging is in the Lounge in the back of the 300 aisle.

General Information

Program Changes KNect365 does everything in its power to ensure there are no changes to the published program but sometimes circumstances that are beyond our control (i .e . speaker cancellations, speaker changes, etc .) do arise . In the event this does occur, every effort is made to find a suitable replacement. Please Note: The listings and contents of this book are proprietary and cannot be reproduced in part or in whole without permission . Every effort has been made to ensure the accuracy of this Guide . However, KNect365 Life Sciences cannot be held responsible for errors or omissions . Product names may be trademarks or registered trademarks of their companies .

Assistance and Special NeedsOrganizers of the BioProcess International™ Conference West fully support the Americans with Disabilities Act . If you require assistance of any kind, please inquire at Attendee Registration .

Lost and FoundItems found can be dropped off at Attendee Registration . Items not claimed by the conclusion of the conference will be turned over to building security .

WiFi Sponsored by:

WiFi Network: MaxCyte Password: Expert2019

Health and Safety Guidelines

The fire alarm sound in this building is a siren

If you discover a fire raise the main alarm at the security desk

Do not stop to collect your belongings or use elevators

Do not obstruct any exits or gangways

There is a no smoking policy at this event

The assembly point for this event is located at the Santa Clara Convention Center - Front Parking Area

Should you require special assistance please tell a member of KNect365 staff

Please be responsible when plugging laptop and mobile chargers into sockets


Thank You to Our Sponsors

Event Partners:

Platinum Sponsor:

Gold Sponsors:

Silver Sponsors:

Bronze Sponsors:

Presentation Sponsors:

Technology Workshop Sponsors:

Emerging Scientist Award Sponsor: Reception Co-Sponsors:

WiFi Sponsor: Refreshment Break Sponsor : a Hepalink Company

Conference Supporter :

Media Partners:


PASSPORT TO PRIZES – Download the App to Play and Win!Don't miss out on this fun and interactive tour through the Exhibit Hall . Stop by booths marked with a Passport stop around the Exhibit Hall and use the App to scan their QR code . Visit all participating booths up until 3:00 pm on Wednesday, to not only walk away with innovative ideas but to have a chance of winning some fabulous prizes . Prizes will be drawn at 3:45 pm on Wednesday .

1 . Visit each booth in the Exhibit Hall listed in your passport . Each booth will be labeled as a “Passport Stop” .

2 . Download the ‘KNect365’ app on your iPhone or Android then search for ‘BioProcess International US West’ within the app and log in using the credentials emailed to you . If you need your log in credentials, you can reset your password within the app or just visit our team at the registration desk . Use the QR Code Scanner within the app to scan each participating exhibitor .

3 . Attendees are to have scanned ALL participating exhibitors by 3:00 pm on Wednesday . The winners will be announced at 3:45 at the Sales booth #213 . You MUST be present to win .

Prize Donated by Booth

Bose Soundsport Wireless Headphones with a value of $150.

Aber Instruments Ltd 402

$150 AMEX Gift Card Avid Bioservices 401

FitBit BioTechLogic 403

Amazon Echo Boehringer Ingelheim BioPharmaceuticals

220

TBD CPC 912

Fitbit Charge 3 Activity Bundle Cytovance Biologics 603

Black FitBit Smartwatch DPL-US 623

Portable Smartphone Printer FrieslandCampina Ingredients 619

FUJIFILM Instax Square SQ 10 Hybrid Instant Camera with a Twin Pack Film and Hard Travel Case

FUJIFILM Irvine Scientific 306

$150 AMEX Gift Card JNC 805

TBD Lewa Nikkiso 205

Amazon Gift Card $150 MabPlex 909

Bose Bluetooth speaker Meissner Filtration Products 502

Bose SoundSport Pulse headphones MilliporeSigma 405

Amazon Fire 7 Novo Nordisk Pharmatech 914

$150 Visa Gift Card Rentschler Biopharma SE 317

Happy Hour Bundle VR Analytical 702

Thanks to our exhibitors for donating the following prizes:

Check the App for an updated list



Session Room Floor Plans

EXHIBIT HALL

B3

M1M2M3

B1B2

B5B4

ED

FC

GB

HA

MISSION CITY BALLROOM

GRAND BALLROOM

THEATER

SECOND FLOOR

FIRST FLOOR

Entrancefrom Parking

Garage

Entrancefrom Hotel

212

211

210

209208

207

206

205

204

203 202 201

MAIN LOBBYBPI WESTRegistration

Pre-Conference Symposium Grand Ballrooms (A - D)Tuesday Lunch ‘n Learns

Wednesday Breakfast WorkshopWednesday Lunch ‘n Learn

TUESDAYSartorius Stedim Biotech – Meeting Room 203Entegris – Meeting Room 204ForteBio – Meeting Room 209 JSR Life Sciences – Meeting Room 210WEDNESDAY GE Healthcare – Room 209 Advanced Bioprocessing – Room 203 FUJIFILM Irvine Scientific – Room210 Dyadic – Room 204 THURSDAY Fujifilm Diosynth Biotechnologies – Room 204ATUM –Room 203Avid Bioservices – Room 209

Main Conference Tracks

MEETING ROOMS(Technology Workshops)


12 www.BioProcessWest.com *Schedule subject to change

Pre-Conference Symposia • Monday, March 11, 2019 • 8:50 am - 5:00 pm

SYMPOSIUM 1: Microbial Production

SYMPOSIUM 2: Continuous and Intensified

Bioprocessing

SYMPOSIUM 3: PAT and Advanced

Process Control

SYMPOSIUM 4: Cell & Gene Therapy

Bioprocessing Hyatt Ballroom A

9:55 Chairperson’s Opening RemarksCameron Bardliving, Assistant Professor of Bioprocessing, Keck Graduate Institute

10:00 THOUGHT LEADERS DISCUSSION: Where Is, Microbial Production Going?Stefan Krahulec, Senior Manager Technology & Innovation, Boehringer Ingelheim RCV GmbH & Co KGIskandar Dib, Principal Scientist Process Development & Analytics, VALIDOGEN

10:30 Morning Coffee Break and Networking

11:15 Development and Optimization of an Industrial and Scalable Fermentation Process for the Production of Recombinant CRM197 by E.coliMarie-Anne Gauriat, Research Officer, National Research Council of Canada (CNRC)

11:45 Optimizing Expression of an Antibody Fab Fragment in Escherichia Coli with Non-Native Amino Acid (NNAA) Incorporated by Strain Engineering and Process DevelopmentHarun Rashid, Senior Principal Scientist, Ambrx

12:15 Secreted Proteins in High Cell Density Perfusion Cultures of Yeast Pichia Pastors CellsDhinakar Kompala, Founder & CEO, Sudhin Biopharma Company

12:45 Lunch and Networking (Hyatt Ballroom E)

2:00 Developing and Validating Process Monitoring and Control Technologies for Robust Monitoring of Microbial ProductionCameron Bardliving, Assistant Professor of Bioprocessing, Keck Graduate Institute

2:30 Best Practice Model for Collaborative End to End Process Development and Manufacturing using P. PastorisStefan Krahulec, Senior Manager Technology & Innovation, Boehringer Ingelheim RCV GmbH & Co KGIskandar Dib, Principal Scientist Process Development & Analytics, VALIDOGE

3:00 Afternoon Coffee Break

3:30 Session Wrap Up & End of Day Q&A

4:00 End of Symposium

Hyatt Ballroom B 8:50 Chairperson’s Opening Remarks

Tony D'Amore, Ph.D., MBA, Vice President, Product Research and Development, Sanofi Pasteur

9:00 Accelerating Development through Innovation: Advances & Challenges in Vaccine DevelopmentTony D'Amore, Ph.D., MBA, Vice President, Product Research and Development, Sanofi Pasteur

9:30 Prevention & Removal of Contamination in an Open Environment during Continuous ProcessingRaquel Orozco, Senior Bioprocess Engineer, Process Science, Boehringer Ingelheim Fremont, Inc.

10:00 Raman Spectroscopy for Real-Time Process Monitoring in Upstream BioprocessingNobel Vale, Research Scientist II, Bristol-Myers Squibb

10:30 Morning Coffee Break and Networking 11:00 Case Study – USP Intensified

Perfusion & DSP Purification Application: Round TablePriscilla Ngo, Scientist I, Boehringer IngelheimPeter Satzer, Ph.D ., Post-doctoral Researcher, University of Natural Resources and Life Sciences

11:30 Introduction to Novel Modalities & Continuous Bioprocessing: A Look at Antibody Drug ConjugatesDaniel Milano, Senior Development Engineer III, Immunogen

12:00 Design of a Custom Continuous Process for Vaccine FormulationsKirsten Strahlendorf, Senior Scientist, Sanofi Pasteur

12:30 Virus Safety for Continuous ProcessingMark Schofield, Sr. Manager R&D, Research and Development, Pall Biotech

1:00 Lunch and Networking (Hyatt Ballroom E) 2:00 Building Model-Based Solutions

for More PAT In Bioprocessing - Which Data, Expertise And Software Do I Need?Alessandro Butte, Ph.D., Senior Scientist and Lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich

2:30 PAT & The Roadmap to IPC & RTRT for Continuous BiomanufacturingRichard Wu, Ph.D., Principal Scientist, Amgen

3:00 Afternoon Coffee Break 3:30 Challenges And Benefits Of Early

Stage Process Development For Integrated Continuous Biomanufacturing ProcessesAleksandar Cvetkovic, Head of Continuous Manufacturing Skill Center, Sanofi

4:00 Integrated Small-Scale End-to-End System for mAb Production In Process DevelopmentVeronique Chotteau, Ph.D., Director of VINNOVA Competence Centre for Advanced BioProduction by Continuous Processing, AdBIOPRO and Principal Investigator, KTH - Royal Institute of Technology

Hyatt Ballroom C 9:20 Chairperson’s Opening Remarks

Alessandro Butte, Ph.D., Senior Scientist and Lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich

9:30 Real-Time Titer Measurement Methods To Control Protein A Column Loading During Continuous Antibody Production – A Technology OverviewJeff Goby, Scientist II, Boehringer Ingelheim

10:00 Raman Spectroscopy for Real-Time Process Monitoring in Upstream BioprocessingNobel Vale, Research Scientist II, Bristol-Myers Squibb


11:15 The Chemometrics of PAT & Avoiding Excel Hell: Round TableBetty Tso, Cell Culture & Upstream Engineer, Bayer

12:15 Mapping Future Technology Needs for Real-Time Release TestingUdayanath Aich, Ph.D., Principal Scientist, Bioanalytics, Sanofi-Genzyme


2:00 Building Model-Based Solutions for More PAT In Bioprocessing - Which Data, Expertise And Software Do I Need?Alessandro Butte, Ph.D., Senior Scientist and Lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich

2:30 PAT & The Roadmap to IPC & RTRT for Continuous BiomanufacturingRichard Wu, Ph.D., Principal Scientist, Amgen


3:30 A Review of Online Sampling in Pfizer BiotherapeuticsKeith Davis, Principal Scientist, Analytical R&D, Pfizer

4:00 End of Symposium

Hyatt Ballroom D 9:55 Chairperson’s Opening Remarks

Shashi Murthy, Ph.D., Professor of Chemical Engineering & Sherman Center Director, Northeastern University

10:00 Cell Therapy Global Launch: Lessons LearnedPrentice Curry, Senior Vice President Quality and Compliance, Kite Pharma, USA


11:15 Strategies to Increase Cell Culture Productivity: Scaling Up hMSC Bioreactor CultureKatrina Adlerz, Scientist, RoosterBio Inc.

11:45 Adopting Various Manufacturing Closed Systems to Gene Modified T Cell TherapiesAli Mohamed, VP, CMC, Immatics, USA


2:00 Closed Systems/AutomationOhad Karnieli, Ph.D., BA, CEO, Atvio Biotech


3:30 Session Wrap Up & End of Day Q&A

4:30 Fully Integrated Continuous Manufacturing v2.0 – Leveraging Lessons Learned and Technologies to Meet Evolving Biopharma Needs (Mission City B4/B5) Jens Vogel, Ph.D., President & CEO, Boehringer Ingelheim Fremont, Inc.

KEYNOTE ADDRESS


Monday, March 11, 2019 • 8:45 am - 1:30 pm

Boehringer Ingelheim, Fremont, CA

DOWNSTREAM PROCESS DEVELOPMENT SEMINAR AND BOEHRINGER INGELHEIM SITE TOUR

Sponsored by:

Event OverviewBio-Rad Laboratories and Boehringer Ingelheim invite you to attend this event at the Boehringer Ingelheim Campus .

A welcome introduction to Boehringer Ingelheim services and manufacturing facility will begin the morning agenda . We will discuss the growing challenges in process development and chromatography solutions to address these difficulties. The seminar will conclude with a facility site tour and networking lunch .

This event will be held at Boehringer Ingelheim in Fremont, California . A bus will transport you from BPI US West Conference at the Hyatt Regency Santa Clara to and return to the hotel at approximately 1:30 pm .

Topics to be covered• Purification challenges for complex biomolecules

• Case studies demonstrating benefits from new resin functionalities

• Host cell protein clearance and control strategy- detection, characterization and purification development

• Global manufacturing network and technology platforms

• Biopharmaceutical contract manufacturing

• Boehringer Ingelheim Fremont site capabilities and biopharmaceutical track record

Registration Details This is a free event, a BPI US West conference registration is not required to attend . Registration includes round-trip transportation and networking lunch . Bus will depart the Hyatt Regency Santa Clara on Monday, March 11th at 8:45 AM PST .

Requirements Registration is required. Due to limited seat capacity, a confirmation email will be sent to confirm your registration to attend this event.


Main Conference • Tuesday, March 12, 20197:00 Registration & Coffee (Theater PreFunction Area, 2nd floor)

Plenary Session (Theater, 2nd Floor)8:00 Chairperson’s Remarks Nikki Nogal, Ph.D., Senior Biologics Development Consultant, Latham Biopharm Group8:15 The Eulogy of Toby Peach Toby Peach, Coney Associate, BBC Fellow in Community Theatre, Creative Climate Leader9:15

Networking Refreshment Break and Grand Opening of Poster & Exhibit Hall sponsored by a Hepalink Company

TRACK 1: Flexible & Smart

Facilities

TRACK 2: Early Stage Process

Development


Development

TRACK 4: Commercial

Manufacturing & Beyond


TRACK 6: Novel Technologies

Mission City B4 Theater, 2nd floorMission City B4;

Combines with Track 1

Mission City M1 Mission City -M2

9:55 Chairperson’s RemarksBrian Hubbard, Ph.D., Consultant, CMC Bioprocess Consulting, LLC

Chairperson’s RemarksNikki Nogal, Ph.D., Senior Biologics Development Consultant, Latham Biopharm Group

Chairperson’s RemarksBrian Hubbard, Ph.D., CMC Bioprocess Consulting, LLC

Chairperson’s RemarksEdward Mee, Senior Scientist, Live Viral Vaccines Group, National Institute for Biological Standards and Control, UK

Experts Roundtable: Beyond Bioprocessing 4.0: Enabling Technologies, Analytics, & Leveraging the new Digital EraThis panel discussion will focus on case studies and perspectives from industry experts on the implementation of Bioprocessing 4 .0 today, remaining gaps and barriers to overcome while addressing the following topics:• Enabling technologies for

process intensification• Advanced analytical

technologies• Software and automation for

smart facilitiesPanelists:Jeet Sarkar, Head of Biologics IT, Takeda Pharmaceuticals Michael Phillips, Head of Next Generation Processing Applications & Innovation, MilliporeSigmaNuno Pinto, Senior Scientist, Bioprocess Development, Merck & Co Inc.Aleksandar Cvetkovic, Head of Continuous Manufacturing, Skill Center, SanofiModerator:Merrilee Whitney, Head of BioContinuum™ Platform for Next Generation Bioprocessing, MilliporeSigma

Sponsored by:

10:00 Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process ProductivityParrish Galliher, Chief Technology Officer, Upstream, Founder, Xcellerex Inc., a GE Healthcare Life Sciences Company

KEYNOTE ADDRESS: Technology and Innovation for Commercial Manufacturing: Living at the Interface of Development and ManufacturingPaul Wu, Head of Upstream Development, Pharmaceuticals, Bayer

Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process ProductivityParrish Galliher, Chief Technology Officer, Upstream, Founder, Xcellerex Inc., a GE Healthcare Life Sciences Company

A Novel Dual Orthogonal Virus Inactivation in a Single Unit Operation In Antibody ProductionJune Zou, Process Scientist, Pathogen Safety, Bayer Healthcare LLC, USA

10:30 Improvements in Facility Design and Readiness for Diversity of ProductsKen Hamilton, Director of Process Engineering, Genentech

Anticipating Late-stage Needs in Early-stage DevelopmentAaron Chen, Principal Scientist, Seattle Genetics, USA

Improvements in Facility Design and Readiness for Diversity of ProductsKen Hamilton, Director of Process Engineering, Genentech

Effective Inactivation of a Wide Range of Viruses by PasteurisationBirgit Popp, Director Virsu Safety Development, CSL Behring

11:00 Transformation of CAR-T Manufacturing Through Use of Closed-Processing, Process Automation and Strategic Raw Material ConfigurationRandy Schweickart, MS, Director of Engineering, Juno Therapeutics, Inc.

Developing Phase 1 Process with Line of Sight to CommercialNiket Bubna, Upstream Group Leader, KBI

Transformation of CAR-T Manufacturing Through Use of Closed-Processing, Process Automation and Strategic Raw Material ConfigurationRandy Schweickart, MS, Director of Engineering, Juno Therapeutics, Inc.

Virus Barrier Filtration – Eli Lilly Case Study Sean O’Donnell, Principal Research Scientist, Eli Lilly & Company, USA

11:30 THOUGHT LEADERS DISCUSSION: Multiproduct Facilities Review – Evaluating Costs of Goods and Practicalities of ImplementationPanelist: Gene Yoshioka, Sr . Director of Manufacturing, Avid Bioservices

PANEL DISCUSSION: Can We Achieve Single-Phase Process Development? What Will it Take?Moderator: Nikki Nogal, Ph.D., Senior Biologics Development Consultant, Latham Biopharm Group Panelist: Susan Dana Jones, Ph.D., Senior Vice President, Product Development, Harpoon Therapeutics Inc.

THOUGHT LEADERS DISCUSSION: Multiproduct Facilities Review – Evaluating Costs of Goods and Practicalities of ImplementationPanelist: Gene Yoshioka, Sr . Director of Manufacturing, Avid Bioservices

Move to another track

Concurrent Technology Workshops12:00

Meeting Room 204Single-Use Polymers and Performance Janelle Rupkalvis, Field Applications Engineer, Entegris

Meeting Room 210Chromassette®, a 3D Printed Modular Chromatography Platform Enabling Next-Generation, Hyper-Productive Bioprocess PurificationMasayoshi Nagaya, Sr . Global Technology Manager, JSR Life Sciences

Meeting Room 203High-Throughput Development of Perfusion Processes and Implementation of Scalable and Flexible Intensified Manufacturing StrategiesMelisa Carpio, Global Technology Consultant, Sartorius Stedim Biotech

Meeting Room 209Improved Clone Selection in Crude by Combining Titer and Glycan Screening on the OctetViraj Palkhiwala, Product Manager, ForteBio - Biologics by Molecular Devices

Lunch n Learn Presentations (limited seating available) 12:30

Grand Ballroom C

Using Peptones to Achieve Diverse and Demanding Bioproduction GoalsStacy Holdread, Staff Scientist, Advanced Bioprocessing

Grand Ballroom DExtractables Data from Single-Use Systems for the Biopharmaceutical Industry - Need Extractables be such a Difficult and “Controversial” Topic?Dr. Roberto Menzel, Laboratory Manager, Sartorius Stedim BiotechReduction and Control of Risks to Biopharmaceuticals from Particulate Matter in Single-Use SystemsDr Klaus Wormuth, Lead Scientist Particles, Sartorius Stedim Biotech

12:30 Networking Lunch in the Poster & Exhibit Hall


Main Conference • Tuesday, March 12, 2019

TRACK 1: Flexible & Smart

FacilitiesTRACK 2: Early Stage Process Development


Development


BeyondTRACK 5:

Viral Safety

Mission City B4 Theater 2nd floor Mission City B5 Mission City M3 Mission City M11:40 Chairperson’s Remarks

Brian Hubbard, Ph.D., CMC Bioprocess Consulting, LLC

Chairperson’s RemarksDuc Nguyen, Ph.D., Lab Head, Novartis

Chairperson’s Remarks Susan Dana Jones, Ph.D., Senior Vice President, Product Development, Harpoon Therapeutics Inc.

Chairperson’s RemarksBert Frohlich, Ph.D., Principal & Owner, Biopharm Designs, LLC

Chairperson’s Remarks

1:45 Modular Platform Delivery Considerations for Today’s New Drug Production Facilities: Case Studies from Recent Design CompetitionsPeter Cramer, Vice President Life Science Facility Design, Exyte U.S., Inc

Speed to IND: are Stable Pools or Transient Gene Expression Viable Manufacturing Options?Yves Durocher, Ph.D., Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada

Registration Enabling Campaign for Accelerated DevelopmentJessica Wuu, Ph.D. Senior Engineer, Late Stage Cell Culture, Genentech

How to Shorten Launch Timelines for New ProductsJody Logan, Associate Director of Tech Transfer, Genentech

Novel Approach to Achieve Complete Retention of Viruses Using Regenerated Cellulose Viral FiltersWensheng Wang, Sr . Scientist, Global Pathogen Safety, Bayer Pharmaceuticals, USA

2:15 Plug and Play Automation for Single Use EquipmentEugene Tung, Executive Director of Manufacturing IT, Merck MSD

Strategies for Improving Transient Protein Expression in CHO Cell LinesJoseph Abad, Field Application Scientist, MaxCyte

Cellulose Fiber Protein A Adsorbent is Paving the Way for the Future of mAb PurificationJerome Pezzini, Scientist, DSP Breakthrough Skill Center, Sanofi

Managing Lifecycle of a Break Through Therapy Designated ProductNguyen Ly, Director, Global Technical Operations Biologics, Merck & Co.

Hepatitis A/E Case StudyBarry Gooch, Associate Director of Pathogen Safety NC, Bioscience Industrial Group R&D, Grifols, USA

Scientific Track Presentations2:45

Mission City B4

Enabling Efficient Biomanufacturing with Digital InnovationHarlan Knapp, Business Development Manager, GE Healthcare Life Sciences

Theater 2nd floorA Case Study Demonstrating Successful Development of a Cell Line Expressing a Biosimilar Antibody in Freedom™ CHO-S™Mike Brem, Senior Scientist, Cytovance Biologics

Mission City B5

Integrated Data Management from Research to GMP Production in Pharma BiotechTim Noetzel Ph.D, Manager-Process Automation, Roche Diagnostics

Mission City M1Key Requirements for Virus Filters in Clinical and Commercial Virus Filtration Process DevelopmentBrian A. Buesing, Senior Research Associate, Asahi Kasei Bioprocess America

3:20Networking Refreshment Break in the Poster and Exhibit Hall sponsored by

a Hepalink Company

Mission City B4 Theater 2nd floor Mission City B5 Mission City B4 combines with Track 1

Mission City B5; combines with Track 3

4:00 Life After Launch – Factors to Consider when Navigating Post-Approval Process ChangesNathan McKnight, Ph.D., Associate Director, Genentech, Inc.

CASE STUDY: Biologics CMO Overview - A Balance between Quality, Speed and CostQinghai Zhao, VP of Technical Development and Manufacturing, FortySeven Inc

Studies on Endogenous Retrovirus-like Particles in Fed Batch and Continuous Manufacturing: Morphology, Quantification and Clearance Shengjiagn Shawn Liu, Chief Scientist and Head of Global Pathogen Safety, Bayer Pharmaceuticals, USA

Life After Launch – Factors to Consider when Navigating Post-Approval Process ChangesNathan McKnight, Ph.D., Associate Director, Genentech, Inc.

Studies on Endogenous Retrovirus-like Particles in Fed Batch and Continuous Manufacturing: Morphology, Quantification and Clearance Shengjiagn Shawn Liu, Chief Scientist and Head of Global Pathogen Safety, Bayer Pharmaceuticals, USA

(4:20) Viral Clearance Validation Across Continuous Capture ChromatographySrinivas Chollangi, Manager, Bristol-Myers Squibb, USA

(4:20) Viral Clearance Validation Across Continuous Capture ChromatographySrinivas Chollangi, Manager, Bristol-Myers Squibb, USA

4:30 Implementation of PAT and Digital Tools for Real-Time Process Monitoring and Quality ControlBecky Chan, Process Development Scientist, Amgen Inc.

Accelerated Timelines for Complete IND SubmissionsFrank Ritacco, Director, Scientific and Technical Affairs, Patheon, Part of Thermo Fisher Scientific

Implementation of PAT and Digital Tools for Real-Time Process Monitoring and Quality ControlBecky Chan, Process Development Scientist, Amgen Inc.

(4:40) Viral Clearance for a Novel Approach to Continuous Viral FiltrationTarl Vetter, Senior Scientist, Sanofi, USA

(4:40) Viral Clearance for a Novel Approach to Continuous Viral FiltrationTarl Vetter, Senior Scientist, Sanofi, USA

5:00 Data at Your Fingertips: The Benefits of an Integrated Informatics SystemCarly Cox, Process Informatics Manager, Global Engineering, Pfizer

PANEL DISCUSSION: Strategies to Increase Speed from DNA to IND SubmissionPanelists: Frank Ritacco, Director, Scientific and Technical Affairs, Patheon, Part of Thermo Fisher Scientific Fritjof Linz, Head of Product Management Separation, Sartorius-Stedim Biotech GmbH

Virus Clearance Data for Constant Flux Virus Filtration from Continuous Integrated Downstream Process PerspectiveDharmesh Kanani, Sr Scientist, Downstream Development & Operation, Teva Pharm, USA

Data at Your Fingertips: The Benefits of an Integrated Informatics SystemCarly Cox, Process Informatics Manager, Global Engineering, Pfizer

Virus Clearance Data for Constant Flux Virus Filtration from Continuous Integrated Downstream Process PerspectiveDharmesh Kanani, Sr Scientist, Downstream Development & Operation, Teva Pharm, USA

5:30 - 6:30

Networking Reception in the Poster and Exhibit Hall co-sponsored by

and


Main Conference • Wednesday, March 13, 20197:15

Technology Workshop with Continental Breakfast Sponsored by: Mission City B4

Scaling Up? No Problem withNew 80cm Diameter Pre-packed OPUS® ColumnAdam Nelson, Technical Support Specialist, Repligen Corporation

Plenary Session (Theater, 2nd floor))8:00 Chairperson’s Remarks

Bert Frohlich, Ph.D., Principal & Owner, Biopharm Designs, LLC8:05

Challenges and Opportunities in Development of Innovative Vaccines for the 21st CenturyRahul Singhvi, Ph.D., Chief Operating Officer, Takeda Vaccines, Inc.

8:45The Innovator’s Dilemma – Organizing to Drive Performance in a Global Biologics Manufacturing Network

Eric Fallon, Ph.D., Senior Director, PT Technology, Innovation, and MSAT, Genentech, Inc.

9:20Networking Refreshment Break in the Poster & Exhibit Hall

TRACK 1: BioProcessing 4.0


Development


Development


BeyondTRACK 5:

Viral Safety

Mission City B4 Mission City B5Mission City

B4; combineswith Track 1

Mission City M3

9:55 Chairperson’s RemarksGünter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare, Germany

Chairperson’s RemarksMelisa Carpio, Global Technology Consultant, Sartorius Stedim Biotech

Chairperson’s RemarksGünter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare, Germany

Chairperson’s RemarksBarry Gooch, Associate Director of Pathogen Safety NC, Bioscience Industrial Group R&D, Grifols, USA

10:00 Featured Presentation: Digital Transformation to Advance Next-Generation Biomanufacturing through Data Integration and Analytics Tom Mistretta, Director, Data Science, Amgen

Early Stage Perfusion Process Development Of A mAb Using GS-CHO Cell LineBrandon Downey, Principal Engineer, R&D, Lonza Pharma & Biotech

Featured Presentation: Digital Transformation to Advance Next-Generation Biomanufacturing through Data Integration and AnalyticsTom Mistretta, Director, Data Science, Amgen

KEYNOTE PRESENTATION: Regulatory Perspective for Using NGS for Adventitious Virus Detection Arifa Khan, Supervisory Microbiologist, CBER, U.S. Food and Drug Administration, USA

10:30 Case Studies from the Pathway to Industry 4.0Paul Hanson, Director, Technical Operations, Takeda Pharmaceuticals, USA

Integrated Bioprocess from Harvest to Purified Bulk in 6 Hours Ping Y. Huang, Head of Drug Substance Bioprocess, AbbVie

Case Studies from the Pathway to Industry 4.0Paul Hanson, Director, Technical Operations, Takeda Pharmaceuticals, USA

Viral Safety of Fluzone® Egg-based Influenza VaccinesBrooke Dancho, Deputy Director, Sanofi Pasteur, USA

11:00 Industry 4.0 and Continuous Biopharmaceutical ManufacturingSamet Yildirim, MS, PSM, Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc

Featured Presentation - Development of an Automated, on Demand Buffer Preparation System – A Technology Journey from Inception to Implementation to Widespread AdoptionNatraj Ram, Ph. D., Senior Director, Biologics Process Development, Alkermes Inc.

Industry 4.0 and Continuous Biopharmaceutical ManufacturingSamet Yildirim, MS, PSM, Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc

Pushing the Limits of Direct, Real Time, Biologically Relevant Virus QuantificationAntje Schickert, Scientist, Sartorius Stedim Biotech


Meeting Room 203Modifying mAb Glycosylation through Cell Culture Medium Supplementation BD Select™ GlycanMod Pak 100Neelanjan Sengupta, Senior Scientist, Advanced Bioprocessing

Meeting Room 209A Pragmatic Approach to Layout and Automation When Designing a New Biomanufacturing FacilityPeter Genest, Director of Automation Offerings and Strategy, GE Healthcare

Meeting Room 210IS Sf Insect - A New Medium Supporting High-Density Insect Cell GrowthLu Chen, Senior Scientist, FUJIFILM Irvine Scientific

Meeting Room 204C1 Expression Platform Updates as the Alternative to CHO. Sanofi Aventis, Mitsubishi and Others Sign UpMatthew Jones, Chief Commercial Officer, Dyadic

12:00 Lunch n Learn Presentation (limited seating available)

Sponsored by:

Mission City B4

Adopting BPOG Supply Chain Best Practices—Case Studies and Lessons LearnedNiklas Signer, Upstream Security of Supply Program Leader, GE Healthcare Life Sciences Ross Acucena, General Manager, Single-use Consumables, GE Gealthcare Life Sciences

Nicholas Berendt, Director of Global Medical Market Development, Sealed Air Corporation

12:00 Networking Lunch in the Poster & Exhibit Hall


Main Conference • Wednesday, March 13, 2019

TRACK 1: BioProcessing 4.0



TRACK 4: Commercial

Manufacturing & Beyond


TRACK 6: Novel

Technologies

Mission City B4 Mission City B5Chairperson: Lynne Frick, Founder, BioGuides LLC

Mission City B4; combines

with Track 1Mission City M3 Mission City M2

1:10 Chairperson’s RemarksGünter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare, Germany

Chairperson’s RemarksMichael Glacken, Ph.D., Senior Consultant, BPTC

Chairperson’s RemarksGünter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare, Germany

Chairperson’s Remarks Sponsored by:

Novel Technologies in Protein Purification

– Science Applied to Life

Session IIndustry PerspectiveNovel technologies in protein purification & applied application for bioprocess development, industry speakers would provide an overview on novel technologies enabling breakthrough for:• Cell Therapy• Gene Therapy• Personalized medicines -

technologies to enable truly personalized treatments

• Flexible manufacturing• Biologics Process

DevelopmentSpeakers1:10 Chairperson's Opening Remarks: Rahul Singhvi, COO, Takeda Vaccines1:30 Nguyen, Director, External Biologics, Merck1:50 Rick St. John, Head of Digital Sciences, PTDU at Genentech 2:10 Samet Yildirim, Technology Innovation Manager, Boehringer IngelheimEmerging Scientist Award Selection CommitteeRahul Singhvi, COO, Takeda Vaccine, ChairNguyen, Director, External Biologics, Merck - memberRick St. John, Head of Digital Sciences, PTDU at Genentech - memberSamet Yildirim, Technology Innovation Manager, Boehringer Ingelheim

Session IIPerspective from Emerging Scientists2.30 Emerging Scientist Presentation #1 3:00 Emerging Scientist Presentation #23:30 Emerging Scientist Presentation #34:00 Emerging Scientist Presentation #4 4:30 Award committee deliberates on the session and nominates a winner4:45 Presentation of Emerging Scientist Award Winners- Chair & 3M Representative5:00 Close of Session

1:15 Online Cell Culture Titer/Capture Load Density Monitoring and ControlJoe Sexton, Senior Technical Specialist, Genentech, USA

Managing Process Characterization and Validation on a Breakthrough Therapy ProgramMichael Glacken, Ph.D., Senior Consultant, BPTC Joan Connolly, Senior Vice President, Technical Operations, Stemline Therapeutics

Online Cell Culture Titer/Capture Load Density Monitoring and ControlJoe Sexton, Senior Technical Specialist, Genentech, USA

Case Study: Next Generations Sequencing and Adventitious Virus Detection Cassandra Braxton, Senior Manager, Global Quality Control Virology, Biogen, USA

1:45 Real Time Process Analytics Implementation and Establishing Process Monitoring ProgrammesRichard Wu, Principal Scientist / Process Analytics, Amgen, USA

Use of PAT for Process Optimization and Control – Raman for Cell Culture and Antibody ProductionGeorge Zhou, Ph.D., Associate Principal Scientist, Biologics and Vaccine Analytics, Merck & Co., Inc.

Real Time Process Analytics Implementation and Establishing Process Monitoring ProgrammesRichard Wu, Principal Scientist / Process Analytics, Amgen, USA

2nd Generation Reference Materials for Adventitious Virus Detection by Deep SequencingEdward Mee, Senior Scientist, Live Viral Vaccines Group, National Institute for Biological Standards and Control, UK

2:15 Automation and Digitalization in Upstream Process Development: Embedding Advanced Microscale Bioreactors (ambr) in an Efficient Sample and Data WorkflowTimo Frensing, Senior Scientist, Large Molecule Research, Roche Pharma Research and Early Development, Roche Diagnostics GmbH, Germany

How Timeline Compression for Breakthrough Therapies Impact Characterization and ValidationNiket Bubna, Upstream Group Leader, KBI

Automation and Digitalization in Upstream Process Development: Embedding Advanced Microscale Bioreactors (ambr) in an Efficient Sample and Data WorkflowTimo Frensing, Senior Scientist, Large Molecule Research, Roche Pharma Research and Early Development, Roche Diagnostics GmbH, Germany

PANEL DISCUSSION: NGS and Adventitous Agent Detection Edward Mee, Senior Scientist, Live Viral Vaccines Group, National Institute for Biological Standards and Control, UKCassandra Braxton, Senior Manager, Global Quality Control Virology, Biogen, USAArifa Khan, Supervisory Microbiologist, CBER, U.S. Food and Drug Administration, USA

Scientific Track Presentations2:45

Mission City B4Flexible & Smart Facilities – Industry ChallengesLoe Cameron, Director of Analytics & Controls, Pall Corporation

Mission City B5A HIC-up in the Process: How POROS Ethyl Saved the DaySara Snell, Scientist, Cytovance Biologics

Mission City B4Flexible & Smart Facilities – Industry ChallengesLoe Cameron, Director of Analytics & Controls, Pall Corporation

Mission City M3

A Holistic Approach to Upstream Viral SafetyCraig Jackson, Senior Product Manager, MilliporeSigma

3:15 Networking Refreshment Break in the Poster & Exhibit Hall

Mission City B4 Mission City M3 Mission City B5Mission City B4;

combined with Track 14:00 DIY Digital Transformation,

Design and DevelopmentThibault Dutronc, Associate Scientist, Merck Serono SA, Switzerland

Bridging Clone Screening Platforms with Perfusion Bioreactors for Continuous ManufacturingJessica Pan, Senior Scientist, Cell Line Development, Merck

A First-Principles Approach to Cleaning Validation: Rational Acceptance Limits for Biopharmaceutical Process ResiduesRizwan Sharnez, B. Tech., M.S., Ph.D., Scientific Director, Process Development, Amgen Inc.

DIY Digital Transformation, Design and DevelopmentThibault Dutronc, Associate Scientist, Merck Serono SA, Switzerland

4:30 Big Data to Smart Data – Feedback from the BioPhorum Automated Facility WorkstreamBob Lenich, Life Sciences Business Director, Emerson Automation Solutions / BioPhorum Automated Facility Workstream, USA

Rethinking Clonality: Characterization of Phenotypic and Genotypic Diversity in Sub-clones Derived from a Clonal Cell LineHedieh Barkhordarian, Scientist, Drug Substance Technologies, Process Development, Amgen

How to Achieve Tech Transfer Goals? What are the Timelines? How to Overcome the Bottlenecks?Padmadhar Madupu, Technical Manager, Pfizer

Big Data to Smart Data – Feedback from the BioPhorum Automated Facility WorkstreamBob Lenich, Life Sciences Business Director, Emerson Automation Solutions / BioPhorum Automated Facility Workstream, USA

5:00 KEYNOTE ADDRESS: Agile Development and Deployment of Digital Twins in Biotech Process Development: One Unit Operation at a TimeOliver Hesse, Director, Lab Automation and Data Management, Biological Development, Bayer (Mission City B5)

5:30

BPI West Offsite Party. Join us at the Black Oak Casino Resort Club for a fantastic view of the Levi’s Stadium field and a football themed reception featuring cocktails, hors d’oeuvres,

and a raffle for a Joe Montana signed football .


Main Conference • Thursday, March 14, 20197:00 Registration & Coffee

TRACK 1: Single-Use Applications


Development


Development


BeyondMission City B4 Mission City B5 Mission City M3

8:00 Chairperson’s Remarks Chairperson’s RemarksRavindra Pangule, Associate Principal Scientist, Merck & Co., Inc., USA

Chairperson’s RemarksNatraj Ram, Ph. D., Senior Director, Biologics Process Development, Alkermes Inc.

8:15 Evaluation, Implementation, and Process Scale-up to a 2000 L Single Use Bioreactor SystemJesse Knaub, Process Scientist, Upstream Operations, Biopharmaceutical Development, Pharmaceutical Science and Technology, Eisai Inc.

Early Development Assessment Strategies to Predict Successful Molecules: A Case Study on Developability Assessment of Bispecific MoleculesDuc Nguyen, Ph.D., Lab Head, Novartis

The Role of Knowledge Management in Speed and Cost of Development – An Update from Biophorum Technology Roadmap Workstream on Knowledge ManagementBert Frohlich, Ph.D., Principal & Owner, Biopharm Designs, LLC

8:45 “Sustainable Single-Use”: Oxymoron or Opportunity?Mark Petrich, Director, Single-Use Systems Engineering, Merck & Co., Inc.

Rational Design and Early In-Silico Screening for Improved Biophysical Properties of Bispecific AntibodiesPatrick Farber, Ph.D., Senior Scientist, Zymeworks Inc

Manufacturing Continuous Process Improvement for Enhancing the Control Capability of Product Quality Attributes by Biopharmaceutical Product Process Validation LifecycleTing-Kuo Huang, Ph.D., Senior Engineer, Manufacturing Science and Technology, Genentech


Meeting Room 203

Efficient Protein Production Process in Mammalian Cells - Scale and QualityMark Fox, Ph.D, Director of Protein Technologies, ATUM (formerly DNA2.0)

Meeting Room 209

Avid Case Study – Taking your Molecule Through Process ValidationDr. Dave Briggs, Ph.D, Senior Manager, Avid Bioservices Dr. William Leonardi, Ph.D, Project Manager, Avid Bioservices

Meeting Room 204Next Generation Technologies that Yield Higher Quality CHO Clones and Intensified Gene to GMP TimelinesNigel Shipston, Director, Program Design, Fujifilm Diosynth Biotechnologies

9:50 Networking Refreshment Break



Development


Development


BeyondTRACK 5:

Novel Technologies

Mission City B4 Mission City B5 Mission City M3 Mission City M210:25 Chairperson’s Remarks Chairperson’s Remarks

Ravindra Pangule, Associate Principal Scientist, Merck & Co., Inc., USA

Chairperson’s RemarksNatraj Ram, Ph. D., Senior Director, Biologics Process Development, Alkermes Inc.

Analytical Tools

Overcoming Data Silos in Process Development: Batch Data to Multivariate Analysis in 30sTimothy Gardner, CEO, Riffyn, Inc.

Closing the Loop in Bioprocessing with Connected Lab Automation and Data IntegrationMarkus Gershater, CSO, Synthace

10:30 Building a Robust Integrity Assurance Strategy for Single-Use Systems to Enhance Product Security, Patient and Operator SafetyElisabeth Vachette, Head of PM - Fluid Management Technologies, Sartorius Stedim Biotech Carole Langlois, Marketing Manager- Traditional Vaccines, Sartorius Stedium Biotech

Smart Model-Based Digital Solutions for Early Bioprocess DevelopmentAlessandro Butte, Ph.D., Senior Scientist and Lecturer at ETH Zurich, Co-founder and CEO of DataHow, ETH Zurich

Efficient Integration of CPV with the Annual Product ReportBarry Pearson, Principle Scientist, Drug Product Technologies, Amgen, Inc. Carly Cox, Process Informatics Manager, Global Engineering, PfizerGuillermo Gambero, Ph.D., Process Scientist, Technical Services, Pfizer

11:00 PANEL DISCUSSION: Insight on Risk Mitigation in Single-Use SystemsModerator: Michael Tucker, Product Compliance Specialist, Watson-Marlow Fluid Technology GroupPanelists: Ross Acucena, General Manager Single-Use Consumables, GE Healthcare Life SciencesElisabeth Vachette, Head of PM - Fluid Management Technologies, Sartorius Stedim BiotechSponsored by

and

A User Requirement Specification for new Harvest Clarification technology for High Density Cell CulturesAshley Hesslian, Associate Director, Bayer

PANEL DISCUSSION: Interdisciplinary Perspectives on Maximizing the Interplay Between Late Stage and Commercial ManufacturingModerator:Natraj Ram, Ph. D., Senior Director, Biologics Process Development, Alkermes Inc.Panelist:Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Roche

Scientific Track Presentation11:35

Mission City M3Microbial Identification via DNA-Sequencing Method to Support Risk Mitigation Strategies

Anna Carr, Customer Service and Sales Manager, Infinity Laboratories12:05 Networking Luncheon (Mission City Foyer & Ballroom)

Grab your lunch and join us in Mission City B5 for the Insider Round Table Discussion hosted by Dan Stanton


Main Conference • Thursday, March 14, 2019





1:25 Chairperson’s RemarksJeffrey Johnson, New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.

Chairperson’s RemarksRavindra Pangule, Associate Principal Scientist, Merck & Co., Inc., USA

Chairperson’s RemarksJeffrey Johnson, New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.

Mission City B4 Mission City B5 Mission City B4; combined with Track 11:30 Internal Alignment of Standards and

Best Practices Enabling Rapid Low-Cost Deployment of Single UseJeffrey Johnson, New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.

Upstream Strategies to Address Process & Quality Challenges Associated with Molecules of New ModalityRavindra Pangule, Associate Principal Scientist, Merck & Co., Inc., USA

Internal Alignment of Standards and Best Practices Enabling Rapid Low-Cost Deployment of Single UseJeffrey Johnson, New Technology Lead and Director, Global Engineering Solutions, Merck & Co., Inc.

2:00 Current Industry Trends Impacting Drug Substance Manufacturing Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Roche

Overcoming the Issues Observed with Early Stage Production of GlycoproteinsAndrew Mathison, Scientist, Biologics Process Design, Abbott Laboratories

Current Industry Trends Impacting Drug Substance Manufacturing Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Roche

2:30 Biophorum - Suppliers and Bio-Manufacturers Accelerating the Application of Single Use Technologies Through CollaborationTrishna Ray-Chaudhuri, Ph.D., Senior Associate II, Corporate Quality Product Supply Administration, Genentech, Inc.Todd Andrews, Global Sales and Business Development Manager, Bioprocessing, CPC - Colder Products Company

Developing A Robust Downstream Process for Early Phase ADC Manufacturing Under Tight TimelinesChi Zhang, Scientist, Ambrx, USA

Biophorum - Suppliers and Bio-Manufacturers Accelerating the Application of Single Use Technologies Through CollaborationTrishna Ray-Chaudhuri, Ph.D., Senior Associate II, Corporate Quality Product Supply Administration, Genentech, Inc.Todd Andrews, Global Sales and Business Development Manager, Bioprocessing, CPC - Colder Products Company

3:00 Conference Recap, Closing Remarks and Look Ahead to BPI West 2020

SEE YOU NEXT YEAR!

March 9-12, 2020 Santa Clara Convention Center, Santa Clara, CA


4-DAY WEBCAST SERIES May 20-23, 2019 / December 2-5, 2019

BioProcess InternationalDigital Week

2019 Sponsors

Join us for a comprehensive series of expert-led webcasts and useful resources to help you accelerate promising biologics towards commercial success .

FREE Webcasts, Live Q&As, Videos, Posters, and White Papers!


EXHIBITOR SPOTLIGHT

Booth 602

Booth 419

Booth 421

Booth 704

Booth 301

Booth 900

Booth 912

Booth 815

Booth 202

Booth 619

Booth 721

Booth 306

Booth 519

Booth 801

Booth 718

Booth 201

Booth 813

Booth 405

Booth 518

Booth 921

Booth 907

Booth 200

Booth 506

Booth 207

Booth 820

Booth 520

Booth 221

Booth 702

Booth 918


Exhibitor List and Floor Plan

3M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316

Aber Instruments Ltd . . . . . . . . . . . . . . . . . . . . . . . . 402

ABL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 602

Advanced Bioprocessing . . . . . . . . . . . . . . . . . 503

Advanced Instruments . . . . . . . . . . . . . . . . . . . . . 920

Analytical Lab Group . . . . . . . . . . . . . . . . . . . . . . . . . 802

ANGUS Chemical Company . . . . . . . . . . . . 320

Aragen Bioscience . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419

Asahi Kasei Bioprocess . . . . . . . . . . . . . . . . . . . . 605

ATUM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 923

Automated Engineering Services (AES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 809

Avid Bioservices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 401

BASF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 421

Beckman Coulter Life Sciences . . . . . . 704

Bionova Scientific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 803

Bio-Rad Laboratories . . . . . . . . . . . . . . . . . . . . . . . . 406

BioTechLogic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403

Boehringer Ingelheim Biopharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . . . 220

Broadley James . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301

Burkert Fluid Control Systems . . . . . . . . 621

Canopy Biosciences . . . . . . . . . . . . . . . . . . . . . . . . . 900

Charles River Laboratories . . . . . . . . . . . . . . 313

CPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 912

Culture Biosciences . . . . . . . . . . . . . . . . . . . . . . . . 315

Cygnus Technologies, LLC . . . . . . . . . . . . . . 815

Cytovance Biologics . . . . . . . . . . . . . . . . . . . . . . . . . 603

Distek . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 521

DPL-US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 623

Entegris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423

Eppendorf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 204

Farrar Scientific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

ForteBio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 706

FrieslandCampina Ingredients . . . . . . . 619

Fujifilm Diosynth Biotechnologies . 721

FUJIFILM Irvine Scientific . . . . . . . . . . . . . . . 306

GE Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312

Gyros Protein Technologies . . . . . . . . . . . . 519

Hamilton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 801

IDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 722

JNC America – Cellufine . . . . . . . . . . . . . . . . 805

JOINN Biologics US, Inc . . . . . . . . . . . . . . . . . . . 908

JSR Life Sciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307

Kaneka . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 718

KBI BioPharma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Kühner Shaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 813

Levitronix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707

LEWA Nikkiso . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

Lonza . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

MabPlex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 909

MaxCyte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 823

Meissner Filtration Products . . . . . . . . . . . 502

Mettler Toledo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 819

MilliporeSigma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405

Nova Biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 618

Novasep . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 720

Novo Nordisk Pharmatech . . . . . . . . . . . . . . 914

Exhibit & Poster Hall Viewing Hours

Tuesday, March 12 9:15 am - 6:30 pm

Wednesday, March 13 9:15 am - 4:00 pm

FESNACK

SNAC

K

Partnering area

MAIN ENTRANCE

FOOD COURT

220 221 320

419

421

423

518

520

522

519

521

618

620

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621

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718

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820

717 812

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912

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801

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401

406307

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203

205 304

306207

300200

202

204

206

FOOD COURT

FOOD COURT

Lounge

312213

316

313

315

317

412

Sales Office


Exhibitor List and Floor Plan

Ology Bioservices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 902

optek Danulat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 723

OriGen Biomedical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 821

Pall Biotech . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717

Parker Bioscience Filtration . . . . . . . . . . . . 518

Patheon, part of Thermo Fisher Scientific . . . . . 304

PendoTECH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 916

PerkinElmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 921

Premas Biotech . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 907

Prometic Bioseparations . . . . . . . . . . . . . . . . . 200

Qosina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 400

Rentschler Biopharma SE . . . . . . . . . . . . . . . . 317

Repligen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 506

Roche Custom Biotech . . . . . . . . . . . . . . . . . . . . 504

Saint-Gobain Performance Plastics . 207

Sartorius Stedim Biotech . . . . . . . . . . . . . . . . . 412

Shimadzu Scientific Instruments . . . 817

Spectrum Chemical . . . . . . . . . . . . . . . . . . . . . . . . . . 820

Stelis BioSource . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 904

Syngene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 800

Teknova . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 922

TeraPore Technologies, Inc . . . . . . . . . . . . . 522

Texcell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 520

Thermo Fisher Scientific . . . . . . . . . . . . . . . . . . 300

Tosoh Bioscience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Vanrx Pharmasystems . . . . . . . . . . . . . . . . . . . . . 221

VR Analytical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 702

Watson Marlow Fluid Technology . 918

xBiologix Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 807

FESNACK

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Lounge

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Sales Office


Exhibit & Poster Hall Viewing HoursTuesday, March 12 9:15 am - 6:30 pm

Wednesday, March 13 9:15 am - 4:00 pm


Poster Presentations

ANALYTICS, MODELS AND INSIGHTSA1 Integration of Imaged cIEF with Mass Spectrometry Accelerates the

Identification of Charge Variants in Intact Monoclonal AntibodiesScott Mack Intabio

A2 Multiphysics Modeling of a Water/Liquid Disinfection System Using Concentrated High-Intensity Electric Field

Peng Peng University of Minnesota

A3 An Integrated Stepwise Approach to Developability Assessment of Therapeutic Antibody Candidates from Discovery to Development

Amisha Kamal Aragen Biosciences

A4 Case Study for Developability Assessment of Three Therapeutic Antibodies

Zhiping Yao JOINN Biologics

A5 Use of a New At-line In-Process Titer Determination Method: Roche Cedex Bio/Bio HT IgG Assay

Geeta Singh Genentech, Inc

A6 Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

Alla Ziberman Cygnus Technologies

CELL & GENE THERAPIESB1 Rapid Quantification of Adeno-Associated Virus (AAV) and Lentiviral

Vectors with the Virus Counter® Platform: Near-Real-Time Monitoring of Viral Vector Production

Antje Schickert Sartorius Stedim Biotech

B2 Novel Transposase Tools for Cell-Line Engineering Claes Gustafsson ATUM

COMMERCIAL MANUFACTURINGC1 Development of Gibco™ Qp-CHO™ Medium through Multi-Omic Analysis Paul Gulde Thermo Fisher Scientific

C2 Qualification of diluents for CINQAIR® (Reslizumab) Solution for Infusion Amit Wani Teva Pharmaceuticals

C3 Amsphere A3 Column Packing from Lab to Manufacturing Scale Kristi Haskins JSR Life Sciences

C4 The Cost of Buffer and Process Liquid Preparation; An Outsourcing Guide Becky Moore Thermo Fisher Scientific

CONTINUOUS PROCESSINGD1 Benefits of Automated In-Line Buffer Preparation Enrique Carredano GE Healthcare

D2 Innovative Single-Pass Tangential Flow Filtration Cassette for Continuous Diafiltration

Martin Longley Sartorius Stedim Biotech

D3 An Efficient Two-Step Purification Workflow for Monoclonal Antibodies from Cell Culture; A) Rapid Capture on a New 70µM Cross-Linked Cellulose Bead Based Rprotein A Capture Resin, Followed by B) A Linked Flow Through Polishing Step on Novel Mixed Mode or Ion Exchange Resins.

Malcolm Pluskal JNC America Ltd

EARLY STAGE PROCESS DEVELOPMENTE1 CRISPR-based Engineering of CHO Cell Lines Sharon Beasley Maxcyte

E2 Strategies for Improved Protein Expression, Production Timelines and Laboratory Productivity Using CHO Cell Transient Expression

Joseph Abad Maxcyte

E3 Novel Gas Mixture Sparging for Increased Productivity of CHO Cell Cultures

Jennifer Leonardi Air Liquide

E4 Improved Clean-in-Place Strategy for the MabSelect SuRe LX Chromatography Media

Richard Wu AbbVie


Poster Presentations (continued)

E5 Case Study: Tech Transfer & Supporting Facility Fit Optimization of a High Concentration Protein

Cate Conderino Alexion Pharmaceuticals Inc

E6 Use of High Throughput Techniques in Purification Process Development of Antibody Drug Conjugates and Novel Bio-Therapeutics

Elaheh Binabaji Amgen Inc

E7 Innovative Strategies for Enhancing Host Cell Proteins and Impurities Clearance in Clarification and Downstream mAb-process Platforms

Jerry Robinson Chiral Technologies / DAICEL

E8 Platform Process for Antibody Fragments Using Cellulose Based Affinity Chromatography Resins

Harkewal Singh Kaneka

E9 High-capacity Capture of a Recombinant Growth Factor Directly from Refold Solution Using Salt-Tolerant Cation Exchange Chromatography

Kate Chefer MilliporeSigma

E10 Rapid Alternatives to Viral Safety Testing Kathryn Remington MilliporeSigma

E11 A Cutting-Edge Improvement for Biologics Manufacturing Attila Huang Mycenax Biotech Inc.

E12 IgG Glycan Screening Assays in Crude Cell Culture Supernatants Sebastian Giehring PAIA Biotech GmbH

E13 Bispecific Antibody Aggregates Removal using Hydrophobic Interaction Chromatography (POROS-HIC) Resins in Flow-through Mode

Billy Yang Sutro Biopharma

E14 Scalable Affinity Chromatography in Antibody Purification and Antibody Fragments Reduction

Cory Chen Sutro Biopharma

E15 Separation of Charge Variants and Aggregates in Protein Purification Process

Ying-Pen Chen Bionova Scientific

EARLY STAGE PROCESS DEVELOPMENT (continued)



E16 Self-Assembled Isoporous Nanofilters for High Throughput Viral Clearance Applications in Bioprocessing

Christopher Crock TeraPore Technologies

E17 Automating At-Line Titer Measurement With A Novel Fit-For-Purpose Chromatographic Device

Craig Love IDEX Health & Science

E18 Opportunities, Challenges, and Economic Drivers for Start-To-Finish Continuous Biomanufacturing

Avril Vermunt GE Healthcare

E19 Machine Learning For Predictive Antibody Design and Humanization Mark Fox ATUM

FLEXIBLE FACILITIES/SINGLE-USEF1 Process Economy Impact of Using a Highly Alkaline-Stable,

High-Capacity Protein A Chromatography ResinHans Blom GE Healthcare

F2 Advanced Manufacturing in Rocking Motion Bioreactors Vincent Lam Sartorius Stedim Biotech

F3 Development of Medium Concentrates to Improve Operational Efficiency and Reduce Cost for Manufacturing of Monoclonal Antibodies

Xiaorui Yang Amgen Inc

F4 Enhancing the Single Use Bioreactor Controller for Dual Control Capability Edward Chan Genentech, IncF5 Compatibility Evaluation of Polysulfone Sensor Bodies with Dimethyl

Sulfoxide (DMSO)Dennis Annarelli & Mark Marrano

PendoTECH

F6 A Single-Use Downstream/Flow-Through pH Sensor with Coplanar Design and Built-in Calibration Capability

CD Feng Broadley James Corp

F7 Identification of Operational Parameters for Cell Culture Scale-up in Various Disposable Bioreactors.

Melissa Gutierrez Bionova Scientific

EARLY STAGE PROCESS DEVELOPMENT (continued)



F8 Enhancing Single-Use Bioreactor Equipment for Scale-Up of Adherent Cell Culture Applictions

Nephi Jones Thermo Fisher Scientific

F9 12 Month Post-Gamma Aging Qualification of Hamilton OneFerm VP 70 Single-Use pH Sensor for Large Scale Use in Single Use Bioreactor

Nephi Jones Thermo Fisher Scientific

LATE STAGE PROCESS DEVELOPMENTG1 High Productivity Harvest: Improved Output and Simplified Clarification

of Fed-batch Cultures using the XCell™ ATF SystemSudhir Prahbu Repligen

G2 UFDF Recovery Strategy for High Concentration Monoclonal Antibody at Manufacturing Scale

Saranya Sivanandam

Alexion Pharmaceuticals

G3 Overcoming the Challenges in Cell Culture Platform Development of mAb Production with Site-Specific Incorporation of Non-Natural Amino Acid for ADC Generation

Weimin Lin Ambrx Inc

G4 Stabilizing Freeze-Labile Biologics Formulations using Antifreeze Polypeptides

Xin Wen California State University Los Angeles

G5 Mechanistic Modeling as a Tool to Streamline Downstream Process Development, Scale-Up, and Characterization

Thiemo Huuk GoSilico GmbH

G6 A New Hydrophobic AEX Resin for Optimal Target Protein Selectivity and Recovery

Khaled Mriziq Bio-Rad

G7 Purification of a Recombinant Protein from E. coli Fermentate with Mixed-Mode Chromatography Resins

William Rushton Bio-Rad

FLEXIBLE FACILITIES/SINGLE-USE (continued)


BioProcessInternationalSeptember 9-12, 2019Boston Convention & Exhibition CenterBoston MA

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Register by April 19 and Save $1000www.BPIevent.com

Documents

BioProcess International US Westdownload.knect365lifesciences.com/2019/B19155Guide.pdfBioProcess International US West EVENT GUIDE March 11-14, 2019 Santa Clara Convention Center Santa