FINAL PROGRAM

WCBP 2017

21st Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology

Health Products

Symposium Co-Chairs: Michele Dougherty, CDER, FDA Michael Kennedy, CBER, FDA

Joseph Kutza, MedImmune, A member of the AstraZeneca Group

The Mayflower Hotel Washington, DC

January 24-26, 2017

Table of Contents Symposium Program Partners................................................................................................1

Exhibitor Partners ..................................................................................................................3

Media Partners .......................................................................................................................4

Acknowledgements ................................................................................................................5

General Information ...............................................................................................................8

CASSS Mobile App ...............................................................................................................11

CASSS WCBP 2017 Student Travel Grants ..........................................................................12

Floor Plans of Meeting Space ................................................................................................13

WCBP 2017 Bird’s Eye View ...............................................................................................14

Scientific Program Summary .................................................................................................15

Technical Seminar (Tuesday, January 24) Abstracts .............................................................29

Technical Seminar (Wednesday, January 25) Abstracts........................................................34

Technical Seminar (Thursday, January 26) Abstracts ...........................................................43

Poster Session One (Wednesday, January 25) Abstracts .......................................................48

Poster Session Two (Thursday, January 26) Abstracts ..........................................................56

Roundtable Session One (Tuesday, January 24) Descriptions ..............................................66

Roundtable Session Two (Wednesday, January 25) Descriptions.........................................73

1

The Scientific Organizing Committee gratefully acknowledges the Symposium Program Partners for their generous support of WCBP 2017:

Strategic Diamond Program Partners

F. Hoffmann-La Roche Ltd. Genentech, a Member of the Roche Group Strategic Platinum Program Partners

AbbVie, Inc. Biogen

MedImmune, A member of the AstraZeneca Group Strategic Gold Program Partners

Eli Lilly and Company Pfizer, Inc.

Diamond Program Partners Catalent Pharma Services

Celgene Corporation ProteinSimple

Platinum Program Partners ProZyme, Inc.

SCIEX Waters Corporation

Gold Program Partners Agilent Technologies

Amgen Inc. Bill and Melinda Gates Foundation

Shire Silver Program Partners

Bristol-Myers Squibb Company Novo Nordisk A/S

2

Symposium Program Partners continued

Bronze Program Partners Bruker Daltonics, Inc.

GlaxoSmithKline Merck & Co., Inc.

Friends of CASSS BioMarin Pharmaceutical Inc.

Janssen R&D, LLC Sanofi

Seattle Genetics, Inc. Welcome Reception Host

EAG Laboratories

3

The Scientific Organizing Committee gratefully acknowledges the Exhibitor Partners for their generous support of WCBP 2017:

Exhibitor Partners

Agilent Technologies New England BioLabs, Inc.

Associates of Cape Cod, Inc. Postnova Analytics Inc.

Avid Bioservices, Inc. PPD

Beckman Coulter Life Sciences Protein Metrics

BioPhia Consulting, Inc. / Atheln Inc.

ProteinSimple

BioReliance Corporation ProZyme, Inc.

Bruker Daltonics, Inc. SCIEX

Catalent Pharma Solutions SGS Life Science Service

CMP Scientific, Corp. Solentim Limited

Envigo Solvias, Inc.

Eurofins Lancaster Laboratories Thermo Fisher Scientific

Genedata AG U.S. Pharmacopeial Convention

Genovis AB Waters Corporation

KBI Biopharma Inc. Wyatt Technology Corporation

NanoImaging Services

4

The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of WCBP 2017:

Media Partners

American Laboratory / Labcompare American Pharmaceutical Review

Analyst / Analytical Methods BioProcessing Journal

BioProcess International ChemComm / ChemSocRev / Chemical Science / Green Chemistry

Genetic Engineering & Biotechnology News G.I.T Laboratory Journal

Integrative Biology / MedChemComm/ Molecular BioSystems International Pharmaceutical Quality (IPQ)

LC/GC North America Pharmaceutical Outsourcing Royal Society of Chemistry

separationsNOW.com Technology Networks

The Analytical Scientist / The Pathologist

5

Acknowledgements

Symposium Co-chairs: Workshop Committee Co-chairs: Michele Dougherty, CDER, FDA Anissa Cheung, CBER, FDA Michael Kennedy, CBER, FDA Juhong Liu, CDER, FDA

Joseph Kutza, MedImmune, A member of the AstraZeneca Group

Shawn Novick, Seattle Genetics, Inc.

Roundtable Chair: Stefanie Pluschkell, Pfizer, Inc.

Steering Committee: Kathleen Francissen, Genentech, a Member of the Roche Group

Ilona Reischl, AGES-Austrian Federal Office for Safety in Health Care

John Frenz Marjorie Shapiro, CDER, FDA Ingrid Markovic, CBER, FDA Robert Sitrin, PATH

Brian K. Nunnally, Biogen

Emeritus Member of the Steering Committee: Robert Cunico, Pacific Bio Labs Michael Kunitani, Marin Analytical Consulting

William Hancock, The Barnett Institute, Northeastern University

Thomas Layloff, Supply Chain Management System

Special thanks to all the Workshop Session Co-leaders Special thanks to all the Roundtable Facilitators and Scribes

6

Acknowledgements continued

WCBP 2017 Scientific Organizing Committee: Sid Advant, Celgene Corporation Kathy Lee, Eli Lilly and Company

Kris Antonsen, BioMarin Pharmaceutical Inc. Patsy Lewis, Seattle Genetics, Inc. Cheryl Blasie, Bristol-Myers Squibb Company Aston Liu, GlaxoSmithKline

Markus Blümel, Novartis Pharma AG William Matousek, Regeneron Pharmaceuticals, Inc.

Christopher Broomell, Takeda Pharmaceuticals North America, Inc.

Kenneth Miller, MedImmune, A member of the AstraZeneca Group

James Carroll, Pfizer, Inc. Edwin Moore, University of Illinois Andrew Chang, Novo Nordisk Inc. Jamie Moore, Genentech, a Member of the Roche

Group Michael Chang, Shire Linda Narhi, Amgen Inc.

Xiao-Ping Dai, Celgene Corporation Julia O’Neill, Tunnell Consulting Bharat Dixit, Genocea Biosciences Joann Parker, Pfizer, Inc.

John (JR) Dobbins, Eli Lilly and Company Francis Poulin, Sanofi Narasaiah Dontha, Celgene Corporation Carmilia Jiménez Ramirez, Gilead Sciences

Roman Drews, LFB-USA, Inc. Steven Raso, Genocea Biosciences Julia Edwards, Biogen Lesley Redfern, AbbVie, Inc.

William Egan, GlaxoSmithKline Vaccines Daisy Richardson, Merck & Co., Inc. Michelle Frazier, Coherus Biosciences Roberto Rodriguez, Bristol-Myers Squibb

Company Stephen Hadley, Bill and Melinda Gates

Foundation Sushmita (Mimi) Roy, BioMarin Pharmaceutical

Inc. Fadi Hakki, MedImmune, A member of the

AstraZeneca Group Timothy Schofield, GlaxoSmithKline

Reed Harris, Genentech, a Member of the Roche Group

Sally Seaver, Seaver Associates LLC

John Hennessey, NovaDigm Therapeutics, Inc. Emily Shacter, ThinkFDA Ping Hu, Janssen R&D, LLC Zahra Shahrokh, STC Biologics, Inc.

Chi-Ting Huang, CTH Analytical Consulting Bryan Silvey, Kite Pharma Peter Johnson, 3M Drug Delivery Systems Arne Staby, Novo Nordisk A/S

Maura Kibby, U.S. Pharmacopeial Convention Annie Sturgess, Bristol-Myers Squibb Company John Kim, Teva Pharmaceuticals Patrick Swann, Biogen

Kevin King, Pfizer, Inc. Garry Takle, Merck, Sharp and Dohme Carol Krantz, Sierra Oncology Ziping Wei

David Lee, Mersana Therapeutics Heidi Zhang, Genentech, a Member of the Roche Group

7

Acknowledgements continued

Collaborating Organizations: American Association of Pharmaceutical

Scientists, Biotech Section (AAPS) National Institute of Standards and Technology

(NIST) American Chemical Society, Division of

Analytical Chemistry (ACS, DAC) Pharmaceutical & BioScience Society (PBSS)

Chinese Biopharmaceutical Association (CBA) Sino-American Pharmaceutical Professional Association – Greater Philadelphia (SAPA-GP)

MASSSEP.org

CASSS Staff: Karen A. Bertani, CMP, Global Community and

Knowledge Sharing Director, (WCBP Symposium Manager)

Amy Cano, Administrative Coordinator Stephanie L. Flores, CAE, Executive Director

Julia Fowle, Meeting Coordinator Anna Lingel, Meeting Coordinator

Carisa Lubeck, Business Information Analyst Renee Olson, Senior Program Manager (WCBP

Exhibit Manager) Catherine Stewart, Finance Manager

Audio Visual: Michael Johnstone, MJ Audio Visual Productions

8

General Information

Name Badges: Please wear your name badge in order to gain admittance to the meetings, plenary sessions, exhibit hall and social functions. A name badge for a one-day registration does not include the cost of the Welcome Reception for the National Archives Museum. Guest tickets to the Welcome Reception may be purchased at the registration desk at a cost of $95.00. Registration: The Symposium Registration Office will be located off the Promenade Foyer in the Senate Room located on the first floor of the hotel throughout the program dates: Tuesday, January 24 through Thursday, January 26. Registration is open during the following hours: Tuesday, January 24 7:00 to 17:00 Wednesday, January 25 8:00 to 17:00 Thursday, January 26 8:00 to 17:00 Roundtable Sessions: This year at WCBP 2017, there are two roundtable sessions. The first session will be held on Tuesday, January 24 from 14:45 to 15:45 and the second session will be held on Wednesday, January 25 from 16:30 to 17:30. The roundtables will be held in the three rooms listed below:

• Cabinet Room • District Ballroom • Palm Court Ballroom

There are 61 roundtable topics - 30 will be held on Tuesday and 31 on Wednesday. Each session will last 60 minutes. Certain topics will be repeated on both days. There will be twelve (12) seats to a table. Seating will be on a first come, first serve basis. These roundtables will include a facilitator, whose role is to help assist the discussion and ensure a lively exchange, and a scribe, whose role is to make general anonymous notes about the discussion so others will have a chance to view the discussion even if they could not participate. The discussion notes will be posted to the CASSS Website within a three week period after WCBP ends for all CASSS members to access. CASSS staff will be available in each room to start the sessions on time and provide a five-minute warning when the session is about to end. The roundtable topics are posted in the back of the final program book.

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General Information continued

Workshop Session Formats: Different workshop topics need to be approached in different ways in order for their full potential to be reached. WCBP 2017 will feature three different workshop formats to enhance discussion of key topics of interest.

1. The Standard Format This is the workshop you usually think of as being associated with WCBP. Industry and Regulatory Agency co-chairs focus on generating discussion over the entire period of the session. As with all workshop formats, audience participation is critical to success.

2. The Speed-dating Format This isn’t your grandmother’s workshop! We’ve kicked it up a notch by essentially facilitating four simultaneous roundtable sessions on four related workshop issues. Every attendee has the opportunity to add their thoughts to each topic in a smaller setting. The facilitators then work hard (and fast) to summarize all the points and report out to the workshop attendees - all in real time.

3. The “Plenshop” Format Sometimes, a presentation of background material before discussion begins is a good thing. The plenshop format allows for that. In these sessions, one or more short presentations will be followed by intensive discussion. It’s not a plenary session, it’s not a workshop - it’s a Plenshop!

Additionally, we will have a workshop in the standard format which will have the topic chosen by WCBP 2017 attendees while at the meeting! We realized that sometimes we may miss an important breaking topic because of how far in advance we work to ensure a high-quality conference. The “Crowd Sourced Hot Topic” workshop allows attendees to suggest and vote for a topic of their choice and we will provide skilled facilitators - whatever the topic! The vote for a “hot topic” will be through the CASSS mobile app. Please make sure to download the mobile app so that you can cast your vote! Poster Sessions: All posters will be set up the entire three days of the Symposium in the “White Space Lounge”, located on the second floor. Posters will be presented on Wednesday and Thursday mornings from 7:00–8:30. Technical Seminars: Four luncheon technical seminars will be held on Tuesday, January 24 from 13:30-14:30 and three luncheon technical seminars will be held on Wednesday, January 25 from 13:30-14:30. Additionally, we are offering two 30-minute technical seminars during the extended break period on Wednesday, January 25 from 11:15-11:45 and on Thursday, January 26 from 10:45–11:15. Wi-Fi Access: We will have Wi-Fi access available throughout all of our program meeting spaces. The Wi-Fi Code is: CASSS2017

10

General Information continued

Business Center: The Business Center is located on the Mezzanine level as part of the UPS Store. The Business Center is staffed during these hours: Monday through Friday 8:00 to 18:00; Saturday 10:00 to 16:00 and closed on Sunday. However, the computers are still accessible 24 hours/seven days a week; they are self-automated by swiping a credit card. Photographic Equipment: The use of cameras is not permitted during the lecture program, workshops or poster sessions. Cameras are permitted on the exhibit floor. However, permission from the vendors involved must be obtained before photographs can be taken. Social Program Tuesday, January 24, 2017 18:30 – 22:30 Welcome Reception National Archives Museum NOTE: Transportation will be provided. Wednesday, January 25, 2017 07:00 – 08:30 First Time Attendee Breakfast Palm Court Ballroom Access to this event requires a “New Member” ribbon on the badge. Wednesday, January 25, 2017 18:45 – 20:00 Exhibitor Reception East/State Room First Time Attendees: For the second year, a breakfast will be held in the Palm Court Ballroom on Wednesday morning where you will be able to meet with some of our key program planning committee members. To gain access to this breakfast, you will be required to have a “New Member” ribbon on your badge. We hope you will join us at this “Meet and Greet.”

11

CASSS Mobile App

Why use the CASSS mobile app?

o Connect and network with fellow attendees, speakers and exhibitors o View the schedule and create a personalized agenda o Download speaker abstracts and handouts o Take notes, save, and export later o Participate in Exhibitor Trivia game for change to win great prizes o Rate the speakers and sessions o Receive up to date information and messages during the conference o View poster abstracts and connect with poster presenters o Network with fellow attendees, speakers and exhibitors o Search exhibitors and schedule appointments o Learn about everything Washington, DC has to offer!

Get Connected and Get the App today! Here’s how: Step 1: Download the App To access the CASSS 365 app, place this link (www.tripbuildermedia.com/apps/casss365) into the browser on your mobile device or scan the QR code. Alternatively, you can search the name CASSS on the Apple App Store or Google Play Store. The app is available for iPhone, iPad, Android, or computer via HTML 5. Step 2: Register and Login Once you have completed the download, please register and login. Your log in information is the same user ID and password you use to register for a CASSS meeting. If you have forgotten your login information, please click on the link at the bottom of the screen to reset your password. Once you enter those credentials the app will keep you logged in and you can access the entire app and its contents. You can use the same email address and password combination to access the app on other devices. Step 3: Join the Meeting Tap the “Events” icon. Only registered WCBP 2017 attendees will be able to access the meeting app – and it too requires a login the first time you sign in. Here you will enter the same CASSS login information. Once in, you will have access to the entire schedule, session abstracts, speaker handouts and bios – as well as the ability to message and connect with your fellow attendees. You may also post comments and observations, before, during and after the sessions.

Step 4: Connect! Be part of a growing community that will be connecting with one another throughout the year and enjoying the value associated with this convenient technology. Good luck and have fun!

12

CASSS WCBP 2017 Student Travel Grants

CASSS is pleased to provide a limited number of student travel grants for PhD students and post-docs who present applicable posters at the 21st Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (WCBP 2017). PhD students or post-doctoral fellows conducting research at academia throughout the world are eligible. Requirements are:

• Present a poster on a WCBP 2017 topic • Proof of studentship/post-doc status • Recommendation from the supervisor/advisor • An abstract submission • A CV for the candidate

This year’s grant winners include: P-122-W Separation of Synthetic Peptides and Proteins Using Specially Designed OT-CEC Column Ashraf Ali, Won Jo Cheong Inha University, Incheon, South Korea P-211-TH Scaling Global Access to Biotherapeutics: Comparing Trade-offs between Different Manufacturing & Supply Chain Models Donovan Guttieres1, Rachel Sam1,2, Stacy Springs1 , Flora Keumurian1, William Hancock1,3, Paul Barone1, James Leung1, Shannon Stewart1

1Massachusetts Institute of Technology (MIT), Cambridge, MA USA, 2Harvard Business School, Cambridge, MA USA, 3Northeastern University, Boston, MA USA

Meeting Space at a Glance

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Meeting Space at a Glance

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Registration 8:00 - 17:00

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WCBP 2017 Scientific Program Summary

TUESDAY, JANUARY 24, 2017 07:00 – 17:00 Registration in the Senate Room 07:00 – 08:30 Continental Breakfast in East/State Rooms 08:30 – 08:45 CASSS Welcome and WCBP 2017 Introduction in the Grand Ballroom John Frenz, CASSS President

Joseph Kutza, MedImmune, A member of the AstraZeneca Group 08:45 – 09:00 6th Annual William S. Hancock Award Announcement in the Grand Ballroom

Sponsored by CASSS and Presented by Wassim Nashabeh, F. Hoffmann-La Roche Ltd.

Keynote Speaker in the Grand Ballroom

Introduction By: Joseph Kutza, MedImmune, A member of the AstraZeneca Group 09:00 – 09:45 A New Paradigm for Oncology Drug Development

Jeff Allen, Friends of Cancer Research, Washington, DC, USA 09:50 – 11:00

Opening Regulatory Panel with the FDA Panel Discussion in the Grand Ballroom

Session Chair: Joseph Kutza, MedImmune, A member of the AstraZeneca Group Moderator: Jamie Moore, Genentech, a Member of the Roche Group

Panel Members: David Doleski, CDER, FDA USA Steven Kozlowski, CDER, FDA USA Ingrid Markovic, CBER, FDA USA Ginette Michaud, ORA, FDA USA

11:00 – 11:30 Networking Break

Visit the Exhibits in the East/State Rooms and the Posters in the “White Space Lounge”, 2nd Floor

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TUESDAY, JANUARY 24 continued

Strategies for Accelerating Biotherapeutic Drug Development Parallel Session in the Grand Ballroom

Session Chairs: Xiao-Ping Dai, Celgene Corporation and John Joly, Genentech, a Member of the Roche Group

11:30 – 11:55 A Regulatory Perspective on Accelerated Product Development Programs Christopher Downey, CDER, FDA, Silver Spring, MD USA 11:55 – 12:20 Targeted Analytics for Streamlining Process Development of Novel Biologics

Nicholas Bond, MedImmune Limited, Cambridge, United Kingdom 12:20 – 12:45 Registration Enabling Campaign for Accelerated Development: A PPQ

Strategy with Minimal Early Investments to Enable Fast to Market Development for a Promising Monoclonal Antibody

John Eschelbach, Genentech, a Member of the Roche Group, South San Francisco, CA USA

12:45 – 13:00 Panel Discussion - Questions and Answers

Analytical Life Cycle Management - Process Development and Control Strategy Parallel Session in the District Ballroom

Session Chairs: Juliana Kretsinger, Eli Lilly and Company and Aston Liu, GlaxoSmithKline 11:30 – 11:55 Analytics and Product Lifecycle – A Regulatory Perspective Michele Dougherty, CDER, FDA, Silver Spring, MD USA 11:55 – 12:20 Strategies for Analytical Method Replacements for Approved Products

Stephan Krause, AstraZeneca, Gaitherburg, MD USA 12:20 – 12:45 The Complex Relationship between Evolving Analytical Technologies and

the Appropriate Implementation Throughout the Product Lifecycle Dwight Moore, GlaxoSmithKline, Philadelphia, PA USA 12:45 – 13:00 Panel Discussion - Questions and Answers 13:00 – 14:45 Lunch Break – Participants on their own

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TUESDAY, JANUARY 24 continued 13:30 – 14:30 Technical Seminars Innovations to Streamline Standardized Biopharmaceutical Characterization Sponsored by SCIEX Chinese Room NOTE: Lunch is provided for first 100 attendees Overcoming the Challenges of Intact Biotherapeutics Characterization with Ultra-high Resolution Mass Spectrometers and the Latest in Automated Biopharmaceutical Software Packages Sponsored by Bruker Daltonics, Inc. District Ballroom NOTE: Lunch is provided for first 100 attendees N-glycan Analysis using InstantDye Workflows for the Screening and Characterization of Biotherapeutics Sponsored by ProZyme, Inc. Grand Ballroom NOTE: Lunch is provided for first 100 attendees Accelerated Biopharmaceutical Development through Strategic Analytical Partnerships Sponsored by Catalent Pharma Solutions Palm Court Ballroom NOTE: Lunch is provided for first 100 attendees 14:30 – 14:45 Transition Time 14:45 – 15:45 Roundtable Session 1

Select Your Table Topic in One of Three Rooms • Cabinet Room • District Ballroom • Palm Court Ballroom

Please refer to table topics listing in the back of this program book. Table seats are on a first-come, first-serve basis.

15:45 – 16:15 Networking Break Visit the Exhibits in the East/State Rooms and the Posters in the “White Space Lounge”, 2nd Floor

Evolving Regulatory Environment in China

Parallel Session in the Grand Ballroom Session Chair: Andrew Chang, Novo Nordisk Inc. and Yameng (Melly) Lin, Roche (China) Holding

Ltd. 16:15 – 16:40 China Regulatory Framework and Regulatory Reform for the Review and

Approval of Biopharmaceuticals Hui Zhang, China Food and Drug Administration, Beijing, People’s Republic of China

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TUESDAY, JANUARY 24 continued 16:40 – 17:00 Technical Evaluation of Biopharmaceuticals in China and Recent Reforms in

CDE Jianhui Luo, Center for Drug Evaluation, China Food and Drug Administration,

Beijing, People’s Republic of China 17:00 – 17:20 The Role of NIFDC in the Regulation of Biologics in China and the Future

Direction Youchun Wang, National Institute for Food and Drug Control, China Food and

Drug Administration, Beijing, People’s Republic of China 17:20 – 17:45 Panel Discussion - Questions and Answers

Novel Approaches to Demonstrate Comparability Parallel Session in the District Ballroom

Session Chairs: Reed Harris, Genentech, a Member of the Roche Group and Patrick Swann, Biogen 16:15 – 16:40 A Regulatory Perspective on Novel Approaches to Demonstrate

Comparability Frances Namuswe, CDER, FDA, Silver Spring, MD USA 16:40 – 17:05 Statistical Reflections on Comparability for Post-approval CMC Changes Theodoro Koulis, Genentech, a Member of the Roche Group, South San

Francisco, CA USA 17:05 – 17:30 Application of a Risk-based Approach and Advanced analytical Technologies

to Support Comparability Assessments Valerie Tsang, Biogen, Research Triangle Park, NC USA 17:30 – 17:45 Panel Discussion - Questions and Answers 18:30 – 22:30 Welcome Reception at the National Archives Museum Transportation will be provided.

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WEDNESDAY, JANUARY 25, 2017 07:00 – 08:30 Poster Session I in the “White Space Lounge”, 2nd Floor 07:00 – 08:45 Continental Breakfast in the East/State Rooms and the “White Space Lounge”,

2nd Floor 08:00 – 17:00 Registration in the Senate Room 08:30 – 08:45 Transition Time

Keynote Speaker in the Grand Ballroom Introduction By: Joseph Kutza, MedImmune, A member of the AstraZeneca Group

08:45 – 09:30 WHO Standards for Regulatory Evaluation of Vaccines and Biotherapeutic

Products – Current Status and Way Forward Ivana Knezevic, World Health Organization (WHO), Basel, Switzerland

Continuous Manufacturing and High-throughput Analytical Technologies

Plenary Session in the Grand Ballroom Session Chairs: Allison Lehtinen, Biogen and Arne Staby, Novo Nordisk A/S

09:35 – 10:00 High-throughput LC-MS Analysis for Advanced Cell Culture Process

Monitoring Ping Hu, Janssen R&D, LLC, Malvern, PA USA 10:00 – 10:25 Modes of Continuous Downstream Operation: Process Design Implications

Randy Schweickart, Amgen Inc., Thousand Oaks, CA USA 10:25 – 10:50 Transforming the Drug Substance Certificate of Analysis with Right Time

Testing Philippe de Vilmorin, Biogen, Cambridge, MA USA 10:50 – 11:05 Panel Discussion - Questions and Answers 11:05 – 12:00 Networking Break

Visit the Exhibits in the East/State Rooms and the Posters in the “White Space Lounge”, 2nd Floor or attend one of the Technical Seminars

11:15 – 11:45 Technical Seminars Development and Applications of a Versatile CE-MS Interface for Recombinant Therapeutic Protein Characterization Sponsored by CMP Scientific, Corp. Chinese Room The Light Scattering Toolkit for Essential, Fast Biophysical Characterization Sponsored by Wyatt Technology Corporation Palm Court Ballroom

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WEDNESDAY, JANUARY 25 continued 11:45 – 12:00 Transition Time 12:00 – 13:15 Workshop Session 1 Control Systems: QbD and Lifecycle Management for Analytics Standard Chinese Room John Harrahy, Amgen Inc., Patrick Lynch, CDER, FDA, Freyja Williams, CBER, FDA, Boris Zimmermann, Genentech, a Member of the Roche Group Gene Therapy for Hemophilia Plen-shop District Ballroom Robert Baffi, BioMarin Pharmaceutical Inc., Roman Drews, LFB-USA, Inc., Nancy Kirschbaum, inVentiv Health, Desheng Liang, Central South University, China / LFB-France, Mikhail Ovanesov, CBER, FDA, Glenn Pierce, Consultant, Daniel Takefman, Spark Therapeutics, Zenobia Taraporewala, CBER, FDA Global Updates and Recent Trends in the Regulation of Biopharmaceutical Products Plen-shop Grand Ballroom Vered Ben Naim, Ministry of Health, Israel, Piyanan Boonprasirt, Thailand Food and Drug Administration, Fadi Hakki, MedImmune, A member of the AstraZeneca Group, Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Mic McGoldrick, Merck & Co., Inc., Brigitte Ouellette Miller, Takeda Pharmaceuticals North America, Inc., Ilona Reischl, AGES-Austrian Federal Office for Safety in Health Care, Anthony Ridgway, Health Canada, Esenbeckia Torres Guzman, COFEPRIS, Mexico Specification or Characterization? Dissecting Quality Attributes for Antibody Drug Conjugates Standard Palm Court Ballroom Kevin Anderson, Seattle Genetics, Inc., Ken Miller, MedImmune, A member of the AstraZeneca Group, Kristen Nickens, CDER, FDA, Satish Singh, Lonza Biologics

13:15 – 14:45 Lunch Break – Participants on their own

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WEDNESDAY, JANUARY 25 continued 13:30 – 14:30 Technical Seminars Rapid and Robust N-glycan Profiling Workflow for Therapeutic Proteins with UHPLC and Multicapillary CE3500xL Separation of Monoclonal Antibody (mab) and Antibody Drug Conjugates (ADC) Sponsored by Thermo Fisher Scientific Chinese Room NOTE: Lunch is provided for first 100 attendees Cutting Edge Capillary Electrophoresis Technology for Protein Analysis Sponsored by ProteinSimple District Ballroom NOTE: Lunch is provided for first 100 attendees Don’t be Left Out in the Cold: Develop an Effective Characterization to Monitoring to Release Strategy for Your Biotherapeutics Sponsored by Waters Corporation Palm Court Ballroom NOTE: Lunch is provided for first 100 attendees

14:30 – 14:45 Transition Time

Control Strategies for Diverse Immuno-oncology Product Modalities Parallel Session in the Grand Ballroom

Session Chairs: Zahra Shahrokh, STC Biologics and Annie Sturgess, Bristol-Myers Squibb Company 14:45 – 15:10 Control Strategies for Antibody-based Immuno-oncology Products: It Starts

with Product Design Marjorie Shapiro, CDER, FDA, Silver Spring, MD USA 15:10 – 15:35 Connecting Mechanism of Action and Potency Control Sytems for I-O

Products: Characterization and Bioassay Development Strategies Tara Stauffer, Bristol-Myers Squibb Company, Pennington, NJ USA 15:35 – 16:00 Analytical Characterization of Antibody-based Molecules: Strategy and Case

Studies Krishnan Sampathkumar, MacroGenics, Inc., Washington, DC USA 16:00 – 16:15 Panel Discussion - Questions and Answers

Rapid Vaccine Development for Emerging Diseases Parallel Session in the District Ballroom

Session Chairs: Bill Egan, GlaxoSmithKline Vaccines and Ziping Wei 14:45 – 15:10 Development and Licensure Pathways for Vaccines for Emerging Infectious

Diseases Marion Gruber, CBER, FDA, Silver Spring MD USA 15:10 – 15:35 The Ebola Vaccine Story Kay Hunsberger, Merck & Co., Inc., West Point, PA USA

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WEDNESDAY, JANUARY 25 continued 15:35 – 16:00 Bioprotection Organization - A Proposal for a Prospective, Permanent,

Predictably Funded, Platform-based Approach to Develop Vaccines against Emerging Infectious Disease Threats

Ripley Ballou, GlaxoSmithKline, Rockville, MD USA 16:00 – 16:15 Panel Discussion - Questions and Answers 16:15 – 16:30 Networking Break

Visit the Exhibits in the East/State Rooms and the Posters in the “White Space Lounge”, 2nd Floor

16:30 – 17:30 Roundtable Session 2

Select Your Table Topic in One of Three Rooms • Cabinet Room • District Ballroom • Palm Court Ballroom

Please refer to table topics listing in the back of this program book. Table seats are on a first-come, first-serve basis.

17:30 – 18:45 Workshop Session 2 Post Marketing Commitments and Approvals Standard Chinese Room Dawn Kelly, Teva Pharmaceuticals, Robin Levis, CBER, FDA, Michael Mulkerrin, ADC Therapeutics, Qing (Joanna) Zhou, CDER, FDA Materials are Like a Box of Chocolates? Speed Dating District Ballrom Cyrus Agarabi, CDER, FDA, Arifa Khan, CBER, FDA, Rashmi Kshirsagar, Biogen, Duncan Low, Amgen Inc., Edwin Moore, University of Illinois, Nadine Ritter, Global Biotech Experts, LLC, Philip Tsai, Seattle Genetics, Inc. Regulators’ Perspectives from Across the Globe: Enhancing Speed to Patient Through Opportunities for Globalization and Accelerated Review Plen-shop Grand Ballroom Gerald DiDonato, Bristol-Myers Squibb Company, Steffen Gross, Paul-Ehrlich-Institut, Veronika Jekerle, European Medicines Agency (EMA), Eric Karikari-Boateng, Food and Drugs Authority, Ghana, Joann Parker, Pfizer, Inc., Elkiane Macedo Rama, ANVISA, Brazil, Kavita Ramalingam Iyer, Merck & Co., Inc., Anthony Ridgway, Health Canada, Hui Zhang, China Food and Drug Administration (CFDA) Cell Therapies and CAR-T Standard Palm Court Ballroom Ilona Reischl, AGES, Kimberly Schultz, CBER, FDA, Bryan Silvey, Kite Pharma

18:45 – 20:00 Exhibitor Reception in the East/State Rooms

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THURSDAY, JANUARY 26, 2017 07:00 – 08:30 Poster Session II in the “White Space Lounge”, 2nd Floor 07:00 – 08:45 Continental Breakfast in the East/State Rooms and the “White Space Lounge”,

2nd Floor 08:00 – 17:00 Registration in the Senate Room 08:30 – 08:45 Transition Time 08:45 – 09:00 Announcements by Joseph Kutza, MedImmune, A member of the AstraZeneca

Group

Streamlining Biopharmaceutical Development and Quality Control via Multi-attribute Methods Plenary Session in the Grand Ballroom

Session Chairs: Ping Hu, Janssen R&D, LLC and Kevin King, Pfizer, Inc. 09:00 – 09:25 Leveraging the MAM to Reveal New CQAs for our Biotherapeutics Richard Rogers, Just Biotherapeutics, Seattle, WA USA 09:25 – 09:50 Development and Application of a Mass Spectrometry Based Multi-attribute

Method for Protein Therapeutics Jette Wypych, Amgen Inc., Thousand Oaks, CA USA 09:50 – 10:15 Multi-attribute Monitoring of Antibody Modifications in a Quality Control

Laboratory: Points to Consider Patrick Bulau, Roche Diagnostics GmbH, Penzberg, Germany 10:15 – 10:30 Panel Discussion - Questions and Answers 10:30 – 11:30 Networking Break

Visit the Exhibits in the East/State Rooms and the Posters in the “White Space Lounge” or attend one of the Technical Seminars

10:45 – 11:15 Technical Seminars Two-dimensional Liquid Chromatography of Bio Molecules Sponsored by Agilent Technologies Chinese Room High Efficiency Amino Acid Analysis Meets EP Compliance Requirements Sponsored by Eurofins Lancaster Laboratories Palm Court Ballroom

11:15 – 11:30 Transition Time

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THURSDAY, JANUARY 26 continued

11:30 – 12:45 Workshop Session 3 Putting the Relevance into Clinically Relevant Specification Acceptance Criteria Standard Chinese Room Joslyn Brunelle, CDER, FDA, Michael De Felippis, Eli Lilly and Company, Sara Gagneten, CBER, FDA, John Ruesch, Biogen Analysis of Biosimilars Speed Dating District Ballroom Joe Glajch, Momenta Pharmaceuticals, Kyounghoon Lee, Celltrion Inc., Magdalena Leszczyniecka, STC Biologics, Edwin Moore, University of Illinois, Leslie Rivera Rosado, CDER, FDA, Emily Shacter, ThinkFDA Collaborating to Accelerate Technology Innovation in BioPharmaceutical Manufacturing: A BPOG Update Plen-shop Grand Ballroom Jonathan Dakin, BPOG-BioPhorum Operations Group, Beth Junker, BioProcess Advantage LLC Comparability and Biosimilarity: Statistical and Practical Considerations Standard Palm Court Ballroom Lokesh Bhattacharyya, CBER, FDA, Maria Teresa Gutierrez-Lugo, CDER, FDA, Timothy Schofield, GlaxoSmithKline, Stacy Sherling, Eli Lilly and Company

12:45 – 14:15 Hosted Lunch Break in the East/State Rooms

14:15 – 15:30 Workshop Session 4 Cell Line Variants: Characterization and Impact on Product Quality Standard Chinese Room Karin Anderson, Pfizer, Inc., Natalya Ananyeva, CBER, FDA, Chana Fuchs, CDER, FDA, Li Tao, Bristol-Myers Squibb Company Controls for Excipients Standard District Ballroom Jennifer Bridgewater, CBER, FDA, Barthélemy Demeule, Genentech, a member of the Roche Group, Chris Moreton, FinnBrit Consulting, Ashutosh Rao, CDER, FDA ICH Q12 Global Update Plen-shop Grand Ballroom Ashley Boam, CDER, FDA, Andrew Chang, Novo Nordisk Inc., Ingrid Markovic, CBER, FDA, Saroj Ramdas, GlaxoSmithKline, Kimberly Wolfram, Biogen Crowd Sourced “Hot Topic” Standard Palm Court Ballroom Kathy Lee, Eli Lilly and Company , Brian Nunnally, Biogen, Nadine Ritter, Global Biotech Experts, LLC

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THURSDAY, JANUARY 26 continued 15:30 – 15:45 Networking Break in the Promenade Foyer

Transformative Technology for the Pharmaceutical Industry Plenary Session in the Grand Ballroom

Session Chairs: William Hancock, Northeastern University and Edwin Moore, University of Illinois 15:45 – 16:10 The Emerging Technology Program: FDA’s Perspective Mohan Sapru, CDER, FDA, Silver Spring, MD USA

16:10 – 16:35 Case Study in the Development of Biologic-Biologic Fixed Dose

Combinations Ambarish Shah, MedImmune, A member of the AstraZeneca Group,

Gaithersburg, MD USA 16:35 – 17:00 Lessons and Implications for Integration and Automation J. Christopher Love, Koch Institute of MIT, Cambridge, MA USA 17:00 – 17:15 Panel Discussion - Questions and Answers 17:15 – 17:30 Closing Comments and Invitation to WCBP 2018

Shawn Novick, Seattle Genetics, Inc.

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NOTES:

How do you monitor post-translational modifications? How do you determine the linkage sites and loading of your ADC payload? How do you fully characterize a biosimilar? Ask EAG. We Know How.

ABSTRACT SUBMISSION DEADLINE:April 14, 2017 for poster presentation

TOPICS TO BE DISCUSSED:• The Crossroads of Bioassays

& Statistics – Where Scientists and Statisticians Collaborate to Develop Great Bioassays

• New Bioassay Approaches and Technologies: A Brave New World

• Exhibitor Partner Showcase• Application of Bioassays

in Product Development• Regulators: What’s on Your Mind?

MAY 8-9, 2017DoubleTree by Hilton HotelSilver Spring, MD

For program updates, on-line registration, abstract submission, information on exhibiting and/or sponsoring, please scan the QR code or visit www.casss.org.

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Technical Seminar Abstracts

Tuesday, January 24, 2017 13:30 – 14:30

In the Chinese Room Sponsored by SCIEX Sean McCarthy; Mark Lies SCIEX, Brea, CA USA Innovations to Streamline Standardized Biopharmaceutical Characterization Want to make confident standardized biopharmaceutical characterization decisions faster? Learn about streamlined solutions that will enable you to rapidly and accurately identify and quantify critical quality attributes to ensure biotherapeutic comparability, safety and efficacy. You will increase your lab’s efficiency and create some time for yourself.

• Get faster answers from daily biologics characterization workflows such as intact mass and peptide mapping, regardless of your level of MS expertise, with a NEW purpose-built LC-MS system designed for simplicity, robustness and flexibility.

• Why spend your time on long sample preps and runs – plus data analysis. See how you can achieve glycan separation and identification in minutes, significantly faster than current optical detection HILIC methods. Announcing a unique NEW CHEMISTRY.

NOTES:

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Tuesday, January 24, 2017 13:30 – 14:30

In the District Ballroom Sponsored by Bruker Daltonics, Inc. Overcoming the Challenges of Intact Biotherapeutics Characterization with Ultra-high Resolution Mass Spectrometers and the Latest in Automated Biopharmaceutical Software Packages Wolfgang Jabs; Peter Hufnagel; Martin Hedstrom; Fredrik Olsson; Mathew Willetts; Guillaume Tremintin; Detlev Suckau; Jason S. Wood Bruker Daltonics, Inc., Billerica, MA USA Attendees of this technology seminar will hear about the latest advancements in ultrahigh-resolution time-of-flight hardware and their application to the analytical challenges facing innovators and biosimilars characterization labs. Innovations in hardware, software and application specific workflows will be highlighted. Several case studies involving monoclonal antibodies characterization will be presented to highlight:

• How high confidence protein MW measurements improves labs productivity • How automation of routine data processing tasks improves the system utilization time • How automated in- at-line sampling and sample processing can be used for better process

understanding. NOTES:

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Tuesday, January 24, 2017 13:30 – 14:30

In the Grand Ballroom Sponsored by ProZyme, Inc. N-glycan Analysis using InstantDye Workflows for the Screening and Characterization of Biotherapeutics Aled Jones ProZyme, Inc., Hayward, CA USA The structure of N-linked glycans can play a critical role in the pharmacology of therapeutic proteins, potentially affecting immunogenicity, pharmacokinetics and pharmacodynamics. This makes the characterization of N-glycans an essential part of the biotherapeutic development process. We present two InstantDye N-glycan sample preparation and analysis workflows:

• Gly-X with InstantPC sample preparation for in-depth characterization by LC-MS; • Gly-Q, an integrated sample preparation & analysis system for rapid screening using capillary

electrophoresis (CE). Mass spectrometry is often utilized for the characterization of N-glycan structures. Unfortunately, many commonly-used fluorescent tags are limited with regard to MS sensitivity. InstantPC is a novel instant N-glycan labeling reagent that provides markedly increased MS and FLR sensitivity. InstantPC is used in a modular workflow (Gly-X) which utilizes a rapid in-solution digestion, instant labeling, and cleanup of excess InstantPC label prior to analysis. Labeled N-glycans may be prepared in as little as 40 minutes. Additionally, glycan characterization is becoming necessary in the earliest stages of biotherapeutic cell line development, to the point where cell culture screening often requires glycan profiling. This entails significantly increased throughput for sample preparation, analytical instrumentation, data processing and expertise in glycan characterization. We present Gly-Q, an integrated N-glycan analysis platform that combines Gly-X rapid sample preparation with InstantQ dye, rapid separation with a user-friendly CE instrument and a simplified data processing approach, enabling relative N-glycan quantification for 96 cell culture samples within a single workday. NOTES:

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Tuesday, January 24, 2017 13:30 – 14:30

In the Palm Court Ballroom Sponsored by Catalent Pharma Solutions Accelerated Biopharmaceutical Development through Strategic Analytical Partnerships Michael Merges Catalent Pharma Solutions, Morrisville, NC USA Discuss underlying nature of growth in the biologics development market which has led to bioassays being the most outsourced service by biomanufacturers, and the service expected to witness the highest future demand. The presentation will outline the principles, options and drivers for parties to create outsourcing partnerships, as well as demonstrating how such strategies can be effective through a case study. NOTES:

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Wednesday, January 25, 2017 11:15 – 11:45

In the Chinese Room Sponsored by CMP Scientific Corp. Development and Applications of a Versatile CE-MS Interface for Recombinant Therapeutic Protein Characterization Fahim Sarah Zarrin1; Rena Wang1; Shaheer Khan2; Jenkuei Liu2; Baburaj Kunnummal2; James Xia1 1CMP Scientific Corp., Brooklyn, NY USA; 2Thermo Fisher Scientific, South San Francisco, CA USA Recombinant therapeutic proteins are complex and constantly evolving. Deep and accurate evaluation of the critical quality attributes of biopharmaceutical proteins are of paramount importance for assessing product quality, impurities, pharmacokinetics and pharmacodynamics, immunogenicity, and overall safety, efficacy and toxicity. In this regard, the comprehensive characterization of recombinant therapeutic proteins as intact molecules or as chemically/enzymatically generated partial molecules is well suited to the technique of capillary zone electrophoresis - electrospray mass spectrometry (CE-MS). This technical seminar discusses the interfacing of CE with MS using an electrokinetically pumped sheath liquid CE-MS coupling technology (EMASS-II CE-MS technology). The EMASS-II CE-MS interface brings significant advantages over traditional CE-MS interfacing technologies. The combination of electrokinetically pumped sheath liquid flow and the electrode placement results in a steady and stable electrospray at a very low flow rate. This extremely low sheath liquid flow minimizes dilution of sample analytes as they exit the separation capillary, thus maximizing detection sensitivity. The coaxial placement of the electrophoresis capillary and the spray emitter provides critical room for post-electrophoresis-pre-electrospray reaction. By optimizing chemical composition of background electrolyte and sheath liquid, CE-MS conditions can be optimized for both separation resolution and electrospray ionization efficiency. We show that this CE-MS interface can be readily adapted to various mainstream capillary electrophoresis and mass spectrometry systems. Common applications for the analysis of recombinant therapeutic proteins, such as peptide mapping, intact mass analysis, reduced antibody analysis, Lys C limited digestion, as well as fluorescence dye labeled N-glycan analysis will be presented. The potential of this EMASS-II CE-MS system to analyze N-glycans is highlighted in the CE-MS analysis of a novel fluorescent dye, Teal™ labeled N-glycans. We demonstrate that, N-glycans labeled using GlycanAssure™ Teal™ workflow can be well separated under simple capillary zone electrophoresis, and readily detected and quantified using negative mode electrospray ionization mass spectrometry. NOTES:

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Wednesday, January 25, 2017 11:15 – 11:45

In the Palm Court Ballroom Sponsored by Wyatt Technology Corporation The Light Scattering Toolkit for Essential, Fast Biophysical Characterization John Champagne Wyatt Technology Corporation, Santa Barbara, CA USA From aggregates to conjugates and peptides to polysaccharides, light scattering detectors combine with multiple sample preparation and delivery systems to provide a comprehensive suite of biophysical characterization tools. The light scattering toolkit determines molar mass, size, charge, interactions, conformation and conjugation of macromolecules and nanoparticles. This seminar presents an overview of the instrumentation and examples of the tasks relevant to well-characterized biopharmaceuticals that may be accomplished with these tools, focusing on three central techniques: µSEC-MALS-DLS, SEC-MALS-IV and HT-DLS. Two of Wyatt’s light scattering tools contribute major productivity enhancements in a biopharmaceutical setting, greatly increasing the speed of analysis without sacrificing sensitivity: the µDAWN and DynaPro Plate Reader II.

• The µDAWN adds multi-angle light scattering (MALS) and dynamic light scattering (DLS) capabilities to UHPLC, for enhanced resolution and speed in absolute molar mass determination. As will be presented in this seminar, all the standard SEC-MALS-DLS applications such as aggregate, fragment and protein conjugate analysis carry over to µSEC-MALS.

• The DynaPro Plate Reader II brings dynamic light scattering (DLS) to the realm of high-throughput, automated measurements of size, eliminating tedious cuvette-based measurements. In this seminar, the applications of the DynaPro for aggregation and stability studies will be presented.

A heretofore underutilized capability for characterization of size and conformation of biologics is online intrinsic viscosity analysis combined with MALS, or SEC-MALS-IV. The recently-launched ViscoStar III determines hydrodynamic size and size distributions with far greater precision and sensitivity than online DLS. An example of using hydrodynamic size analysis to understand the differing SEC elution profiles of mAbs with similar molecular weights will demonstrate the value of SEC-MALS-IV for well-characterized biologics. NOTES:

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NOTES:

EU

0

90

180

270

360

Minutes10 12 14 16 18 20 22 24 26 28 30

G0

G0F

Man5

G1F[6]

G1F[3]

G2

A1

A1F

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Traditional 2-AB and APTS Labels

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Radisson Blu Royal Hotel, Brussels, Belgium

For more information or to register, visit casss.org

Abstract Submission Deadline 10 February 2017 poster presentation

14-17 MARCH 2017

“ The best conference I have attended in the last 2 years.” – William S.

“ I particularly enjoyed talks given by academics working in collaboration with industry...” – Katherine W.

“ This meeting was long needed in Europe...” – Marta G.

39

Wednesday, January 25, 2017 13:30 – 14:30

In the Chinese Room Sponsored by Thermo Fisher Scientific Rapid and Robust N-glycan Profiling Workflow for Therapeutic Proteins with UHPLC and Multicapillary CE3500xL Anahita D. Eckard Thermo Fisher Scientific, Sunnyvale, CA USA The Applied Biosystems™ GlycanAssure™ glycan analysis and quantitation system has improved the glycoprofiling process with a user-friendly sample preparation workflow that eliminates vacuum centrifugation and toxic reagents. This workflow is highly efficient and can be adapted to CE or LC with equivalent resolution; per-sample analysis time is two minutes using Applied Biosystems™ 24-capillary 3500xL protein quality analyzer or 60 minutes using UHPLC. Separation of Monoclonal Antibody (mAb) and Antibody Drug Conjugates (ADC) Shanhua Lin Thermo Fisher Scientific, Sunnyvale, CA USA Monoclonal antibodies have very complex structures, with many possible post-transitional modifications. Characterization of monoclonal antibodies is a very challenging task and requires multiple chromatographic methods. In this presentation, we will focus on charge variant analysis using linear pH gradient methods based on ion-exchange chromatography, and analysis of antibody-drug conjugates drug-to-antibody ratio forms using polymeric reversed-phase media. NOTES:

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Wednesday, January 25, 2017 13:30 – 14:30

In the District Ballroom Sponsored by ProteinSimple Cutting Edge Capillary Electrophoresis Technology for Protein Analysis Xin Jiang; Stefan Schweiger ProteinSimple, San Jose, CA USA Analysis of a protein sample by cIEF and CE-SDS is critical in establishing the protein’s identity, purity, and heterogeneity. The Maurice system combines two capillary electrophoresis (CE) detection schemes into one fully automated instrument, allowing cIEF or CE-SDS data to be generated in a snap. The proprietary ready-to-use cartridge designs, on-board sample mixing and automated clean up procedures dramatically reduces system maintenance while eliminating cross-contamination concerns. Complimenting Maurice’s streamline operation is a novel native fluorescence cIEF detection mode which significantly increased sensitivity over absorbance. In this presentation, we will review the analysis of a variety of protein simples using the Maurice system. NOTES:

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Wednesday, January 25, 2017 13:30 – 14:30

In the Palm Court Ballroom Sponsored by Waters Corporation Don’t be Left Out in the Cold: Develop an Effective Characterization to Monitoring to Release Strategy for Your Biotherapeutics High resolution analytical technologies are moving out of the realm of characterization and into the regulated environments of late development, manufacturing and QC organizations. Analytical managers are now challenged to not only develop an effective characterization strategy, but participate in the lifecycle planning of those assays as they evolve into attribute monitoring, and validated release assays for a commercial product. Harmonization of platforms across these organizations has remained a challenge to this process, but the development of platforms for both high resolution and routine nominal mass detection that can be deployed across an entire organization have fueled great interest progressing LCMS analysis later in development and into QC organizations. While peptide-centric monitoring of multiple product variants has recently generated great interest and concerns, there is already a progression of developing and validating intact mass profiling QC release assays. In this lunch seminar, our speakers will discuss the benefits of applying the Vion IMS QTof HRMS platform under UNIFI for comprehensive primary structural characterization in support discovery and development efforts, transitioning this platform into regulated late development with a mix of targeted monitoring and new variant identification workflows, and multiple strategies at the intact and peptide map level for effective deployment of critical assays into a QC-lot release environment. NOTES:

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Thursday, January 26, 2017 10:45 – 11:15

In the Chinese Room Sponsored by Agilent Technologies Two-dimensional Liquid Chromatography of Bio Molecules Dat Phan Agilent Technologies, Wilmington, DE USA Characterization of Bio Molecules often requires multiple modes of Chromatography, collecting fractions from one mode to re-inject into another mode. This seminar presents complementary tools to help facilitate and automate two dimensions of Liquid Chromatography. The different modules of a Two-Dimensional Liquid Chromatography (2D-LC) will be described along with the proprietary software managing them. In 2D-LC, the two modes of Liquid Chromatography can be complementary or orthogonal to each other. Several case scenarios will be presented to show applicability of the 2D-LC system and software. NOTES:

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Thursday, January 26, 2017 10:45 – 11:15

In the Palm Court Ballroom Sponsored by Eurofins Lancaster Laboratories High Efficiency Amino Acid Analysis Meets EP Compliance Requirements Andrew D. Schaefer Eurofins Lancaster Laboratories, Lancaster, PA USA In the European Pharmacopeia 8.0, many of the monographed amino acids transitioned to ninhydrin positive substances testing per Amino Acid Analysis 2.2.56, Method 1 – Post-Column Ninhydrin Derivatization. This chapter set the foundation for new compliance requirements for testing of amino acids. Previous iterations of the compendia procedure utilized thin layer chromatography for separation of components coupled with ninhydrin exposure, to visually estimate amino acids. This technique only allowed for qualitative determination of amino acids, as the methodology had limited sensitivity. The transition of the analytical technique to a high pressure liquid chromatograph, equipped with an ion-exchange column, post-column derivatization system, and UV/Vis detector has allowed for more sensitive detection of Ninydrin Positive Substances. The Pharmacopeia expects method performance with a linear working range of 20-500pmol with correlation coefficients exceeding 0.999, a detection limit of 10pmol for most amino acid derivatives, as well as, each individual monograph defining system suitability criteria that must be met. However the EP does not define the specific methodology, reagents and instrumentation required to successfully determine ninhydrin positive substances, creating a gap in understanding and direction for many in the analytical field. Therefore, it is the individual user’s obligation to establish a compliant post –column derivatization method which meets the requirements of the compendia. Utilizing a pH, buffer, and temperature gradient along an ion-exchange column provides a suitable means of accurately quantitating various amino acids via post-column derivatization. This discussion will detail the EP general chapter requirements, a strategy for method development and verification of individual monographs, and case studies exploring challenges in development and establishment. NOTES:

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CMC Strategy Forum Europe 201722-24 May 2017, The Malton Hotel, Killarney, Ireland

6th International Symposium on Higher Order Structure of Protein TherapeuticsApril 3-5, 2017, Gaithersburg Marriott Washingtonian Center, Gaithersburg, MDABSTRACT SUBMISSION DEADLINE: January 6, 2017 oral presentation

March 3, 2017 poster presentation

WCBP 2017: 21st Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health ProductsJanuary 24-26, 2017, The Mayflower Hotel, Washington, DCABSTRACT SUBMISSION DEADLINE: November 30, 2016 poster presentation

Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry14-17 March 2017, Radisson Blu Royal Hotel, Brussels, BelgiumABSTRACT SUBMISSION DEADLINE: 18 November 2016 oral presentation

10 February 2017 poster presentation

Bioassays 2017: Scientific Approaches and Regulatory StrategiesMay 8-9, 2017, DoubleTree by Hilton Hotel, Silver Spring, MDABSTRACT SUBMISSION DEADLINE: April 14, 2017 poster presentation

CMC Strategy Forum North America: CMC Strategies for Cell & Gene TherapyJuly 17-19, 2017, Gaithersburg Marriott Hotel, Gaithersburg, MD

CMC Strategy Forum Latin America 201711-12 September 2017, Hyatt Regency Hotel, Mexico City, Mexico

CMC Strategy Forum Japan 20174-5 December 2017, Tokyo Marriott Hotel, Tokyo, Japan

CMC Strategy Forum North America Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry -and- Production Cell Line Development and Control of Product Consistency during Cell Cultivation – Myths, Risks and Best Practices (parallel Forums) January 23, 2017, The Mayflower Hotel, Washington, DC

CALENDAR OF EVENTSFor all program updates, online registration, abstract submission, information on exhibiting and/or sponsoring, please visit the CASSS website at www.casss.org.

JANUARY 2017 – DECEMBER 2017

photo by Farragutful

CE in the Biotechnology & Pharmaceutical Industries: 19th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small MoleculesSeptember 17-20, 2017, Boston Park Plaza Hotel, Boston, MAABSTRACT SUBMISSION DEADLINE: June 23, 2017 oral presentation

August 18, 2017 poster presentation

14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology IndustrySeptember 19-22, 2017, Boston Park Plaza Hotel, Boston, MAABSTRACT SUBMISSION DEADLINE: May 23, 2017 oral presentation

August 18, 2017 poster presentation

19397_CASSSMarketingCalendar2017_CC17.r1.indd 1 1/10/17 6:00 PM

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48

Poster Abstracts

Wednesday, January 25, 2017 07:00 – 08:30

“White Space Lounge” Second Floor

CHARACTERIZATION In the Pennsylvania Room P-106-W Determination of Disulfide Connectivity of a Glycosylated Insulin-like Protein by Top-down LC-MS with ETD Analysis Serah Liu1, Chen Li1, Shiaw-Lin Wu1, Douglas Richardson2, Yan-Hui Liu2, Huijuan Li2 1BioAnalytix, Inc., Cambridge, MA USA, 2Merck & Co., Inc., Kenilworth, NJ USA P-107-W N‐ and O‐glycan Removal using Mass Spectrometry‐compatible Reagents: Protein Deglycosylation Mix II and Endoglycosidases H, F2, and F3 Alicia Bielik, Paula Magnelli, Stephen Shi, Cristian Ruse, Alex Luebbers, Beth McLeod, Ellen Guthrie New England Biolabs, Inc., Ipswich, MA USA P-108-W Application of Exoglycosidase Arrays to Elucidate and Confirm Glycan Structures on Antibodies Beth McLeod, Alicia Bielik, Paula Magnelli, Ellen Guthrie New England Biolabs, Inc., Ipswich, MA USA P-109-W Antibody Accurate Mass Characterization Enabled by Automated Affinity Purification, Deglycosylation, IdeS Digestion, and Reduction Steve Murphy1, Jing Chen2, Zach Van Den Heuvel1 1Agilent Technologies, Madison, WI USA, 2Agilent Technologies, Santa Clara, CA USA P-110-W Physicochemical and Functional Characterization of a Biosimilar Bevacizumab Ravish Patel Vitane Pharmaceuticals, Inc., Hyderabad, India CHARACTERIZATION In the Rhode Island Room P-102-W Automated Workflow for Host Cell Protein Monitoring by Mass Spectrometry: From Raw Data to Final Report David Bush1, Maurizio Bronzetti1, Aude Tartiere1, Arnd Brandenburg2, Joe Shambaugh1 1Genedata Inc., Lexington, MA USA; 2Genedata AG, Basel, Switzerland

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P-103-W Comprehensive Analysis of Apts-labeled Monoclonal Antibody N-glycans by Capillary Electrophoresis Using LIF and MS Detection András Guttman1, Jeff Chapman1, Marcia Santos1, Bryan Fonslow1, Marton Szigeti2 1SCIEX, Brea, CA USA, 2University of Debrecen, Debrecen, Hungary P-104-W Analysis of Sialylation in Biopharmaceuticals Jenifer Hendel, Louise Royle, Radoslaw Kozak Ludger Ltd., Oxfordshire, United Kingdom P-105-W Generation of a Nicotiana Benthamiana Process-specific Host Cell Protein Antibody Reagent using a Chicken Host Species Sammie McIllwain, Todd Giardiello, Daniel Kenney, David Chimento, Karin Abarca, Maheen Sayeed Rockland Immunochemicals Inc., Limerick, PA USA P-120-W HDX-MS Higher Order Structure Profiling of a Novel Long-Circulating hGH Therapeutic Yaping Sun1, Peter Li1, Shiaw-Lin Wu1, Eric Mueller2, Xiao Liu2, Gary Koe2, Patrick Murphy2 1BioAnalytix, Cambridge, MA USA, 2Versartis, Menlo Park, CA USA P-121-W Comprehensive PTM Characterization of the NIST mAb Reference Standard using an IMS QTOF Mass Spectrometry Henry Shion, Jing Fang, Nilini Ranbaduge, William Alley, Ying Qing Yu Waters Corporation, Milford, MA USA CHARACTERIZATION In the South Carolina Room P-101-W Applications of 2D Heteronuclear NMR Methods to Monoclonal Antibody Therapeutics Luke Arbogast, Robert Brinson, Frank Delaglio, John Marino NIST/IBBR, Rockville, MD USA P-111-W A Case Study for the Characterization of Product-related Substances and Impurities to Support a Biologics Licence Application of a Therapeutic mAb Lorène Bernasconirémi, Rémi Bussat, Anaelle Dos Santos, Sylvain Raimondi, Keith Wilson Novimmune SA, Plan-les-Ouates, Switzerland P-112-W Characterization of Protein and Protein Aggregates using Temperature -controlled Hollow Fiber Flow Field-flow Fractionation Robert Reed1, Soheyl Tadjiki1, Gerhard Heinzmann2, Florian Meier2, Evelin Moldenhauer2, Roland Welz2, Thorsten Klein2

1Postnova Analytics Inc., Salt Lake City, UT USA, 2Postnova Analytics GmbH, Landsberg am Lech, Germany

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P-113-W Automated Amino Acid Analysis for Biopharma Applications using 2.7 μm Superficially Porous High pH Stable Reversed-Phase Columns Sundaram M. Palaniswamy1, Timothy Rice2

1Agilent Technologies, Inc., Bangalore, India, 2Agilent Technologies, Inc,. Wilmington, DE USA P-115-W NISTmAb Reference Material 8671: A Research Tool Grounded in Quality Measurements John Schiel, Trina Formolo, Abigail Turner, Katharina Yandrofski, Srivalli Telikepalli, Kara Huang NIST/IBBR, Gaithersburg, MD USA P-116-W Characterization of the USP Monoclonal IgG System Suitability Reference Standard Dale Schmidt, Anita Szajek, Fouad Atouf, Tina Morris United States Pharmacopeial Convention, Rockville, MD USA P-117-W Harmonizing Physicochemical Analysis of Biotherapeutics St John Skilton, Eric Carlson, Chris Becker, Marshall Bern Protein Metrics, San Carlos, CA USA P-118-W Comprehensive Analysis of CHO Cells using LC-MS/MS and Recurrent Spectral Libraries Kelly Telu, Ramesh Marupaka, Nirina Andriamaharavo, Xinjian Yan, Yamil Simón-Manso, Stephen Stein NIST, Gaithersburg, MD USA P-119-W Streamlining of Primary Sequence Verification and PTM Quantification Workflows with an Integrated Solution for Peptide Maps Acquisition and Processing Guillaume Tremintin1, Jason Wood1, Detlev Suckau2 1Bruker Daltonics, Inc, Billerica, MA USA, 2Bruker GmbH, Bremen, Germany HIGH-THROUGHPUT ANALYTICAL TECHNOLOGY In the Virginia Room P-122-W Separation of Synthetic Peptides and Proteins Using Specially Designed OT-CEC Column Ashraf Ali, Won Jo Cheong Inha University, Incheon, South Korea P-123-W High Throughput and Robust Method of Analysis of a Variety of Immunoglobulin G Derived from Multiple Sources and from Crude Feedstock Using an Analytical Protein A Affinity Chromatography Column Keegan Gike, Atis Chakrabarti Tosoh Bioscience LLC, King of Prussia, PA USA

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P-124-W Fast Glycan Labeling and Analysis: High-resolution Separation and Identification in Minutes Mervin Gutierrez1, Marton Szigeti2, Anna Lou1, Gabor Jarvas2, Eric Chiang1, Mark Lies1, Jeff Chapman1, András Guttman1,2 1SCIEX, Brea, CA USA, 2University of Debrecen, Debrecen, Hungary P-125-W Capillary Isoelectric Focusing with Intrinsic Fluorescence Whole-column Detection Xin Jiang, Jiaqi Wu ProteinSimple, San Jose, CA USA P-126-W N-glycan Analysis by Orthogonal Methods: UHPLC and Multi-Capillary CE Baburaj Kunnummal Thermo Fisher Scientific, South San Francisco, CA USA P-127-W An Integrated System for High-throughput, User-friendly N-glycan Analysis Using Rapid Separation by Capillary Electrophoresis Michael Kimzey, Andres Guerrero, Zoltan Szabo, Shirley Ng, Alexander Gyenes, Aled Jones, John Yan, Justin Hyche, Emily Dale, Ted Haxo, Sergey Vlasenko ProZyme, Inc., Hayward CA USA P-128-W Spectrophotometric Method as a Quantitative Measurement of Color in Protein Drug Solutions for Lot Release and Stability Testing Jian Yin, Trevor Swartz, Bruce Kabakoff, Susan Skieresz, Charles Morgan, Kimia Rahimi Genentech, a Member of the Roche Group, South San Francisco, CA USA MULTI-ATTRIBUTE METHODS In the Virginia Room P-129-W Automated Data Processing for Quality Monitoring of Biotherapeutics by Multi-attribute Methods (MAMs) Maurizio Bronzetti1, David Bush1, Aude Tartiere1, Arnd Brandenburg2, Joe Shambaugh1

1Genedata Inc., Lexington, MA, USA; 2Genedata AG, Basel, Switzerland P-130-W Enabling a Multi-Attribute Method Comparison of Infliximab Eric Carlson1, Chris Becker1, Ilker Sen1, St John Skilton1, Michael Ford2, Sergei Saveliev3, Karthik Pisupati4, Anna Schwendeman4 1Protein Metrics, Inc., San Carlos, CA USA, 2MS Bioworks, Ann Arbor, MI USA, 3Promega Corporation, Madison, WI USA, 4University of Michigan, Ann Arbor, MI USA P-131-W Monitoring Quality Attributes of Biotherapeutic Products using a Mass Spectrometry- based Analytical Platform Jing Fang, Brooke Koshel, Robert Birdsall, Ying Qing Yu, Min Du, Scott Berger, Weibin Chen Waters Corporation, Milford, MA USA

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Poster Abstracts

Thursday, January 26, 2017 07:00 – 08:30

“White Space Lounge” Second Floor

ANTIBODY DRUG CONJUGATES In the Virginia Room P-201-TH Size Exclusion Chromatographic Analysis of Antibody Drug Conjugates (ADC) for the Detection of High and Low Molecular Weight Heterogenic Impurities Keegan Gike, Atis Chakrabarti Tosoh Bioscience LLC, King of Prussia, PA USA P-202-TH High Resolution LC/MS Separation and Characterization of Chemoenzymatic Site-specific Engineered Antibody-drug Conjugates (ADCs) Shanhua Lin1, Terry Zhang2, Brian Agnew3, Jonathan Josephs2, Xiaodong Liu1 1Thermo Fisher Scientific, Sunnyvale, CA USA, 2Thermo Fisher Scientific, San Jose, CA USA, 3Thermo Fisher Scientific, Eugene, OR USA P-203-TH Developability Risk Assessment: Lead Selection for Site Directed and Stochastic Her2 Antibody-drug Conjugates Gary Bishop1, Colin McKee2, C Wodarczyk3, Allan Watkinson1 1Envigo, Cambridgeshire, United Kingdom, 2ADC Biotechnology Ltd., Denbighshire, United Kingdom, 3Rentschler Biotechnologie GmbH, Laupheim, Germany BIOASSAYS / POTENCY ASSAYS In the Virginia Room P-204-TH Qualification of a Potency Assay for Characterization of Golimumab Fab Functional Activity Sebastian Königsberger, Stefan Wanninger, Onofrio Zirafi, Alexander Knorre Eurofins BioPharma Product Testing Munich GmbH, Planegg, Germany P-205-TH Binding Assay as a Surrogate Assay for Functional Assay in Lot Release and Stability Testing: A Case Study Ravish Patel Vitane Pharmaceuticals, Inc., Hyderabad, India

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BIOSIMILARS In the Virginia Room P-206-TH Advances in UV-visible Absorbance Measurements for Concentration Determination of Different Protein Products Nicholas Hellman, Reika Campbell, Heng Zhao, Minhaj Siddiqui, Ian Milne, Amisha Kizhakkedathu Pfizer, Inc., Lake Forest, IL USA P-207-TH Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab Kate Hutterer, Helen McBride, Alla Polozova, Scott Kuhns, Jennifer Liu Amgen Inc., Thousand Oaks, CA USA COMPARABILITY In the South Carolina Room P-208-TH Capillary Electrophoresis Assays for Characterization and Quality Control of the NISTmAb Reference Material Abigail Turner1, John Schiel2

1NIST, Rockville, MD USA, 2NIST/IBBR, Gaithersburg, MD USA P-209-TH Higher Order Structure Stability Analysis on Biologics with Different Modalities Xing Wang, Michael Davies, Guofeng Fu Array Bridge Inc., St. Louis, MO USA P-210-TH Determination of Higher Order Structure Comparability for a Highly Glycosylated Protein by Advanced HDX-MS Approaches Peter Li1, Shiaw-Lin Wu1, Lionel Sison2, Scott Li2, Bernice Yeung2 1BioAnalytix, Cambridge, MA USA, 2Shire, Lexington, MA USA CONTROL STRATEGY / SETTING SPECIFICATIONS In the Virginia Room P-211-TH Scaling Global Access to Biotherapeutics: Comparing Trade-offs between Different Manufacturing & Supply Chain Models Donovan Guttieres1, Rachel Sam1,2, Stacy Springs1, Flora Keumurian1, William Hancock1,3, Paul Barone1, James Leung1, Shannon Stewart1 1Massachusetts Institute of Technology (MIT), Cambridge, MA USA, 2Harvard Business School, Cambridge, MA USA, 3Northeastern University, Boston, MA USA

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P-212-TH Risk Assessment and Control Strategies for Biosimilar Development Amisha Kizhakkedathu, Catherine Srebalus Barnes Pfizer, Inc., Lake Forest, IL USA NEW AND EMERGING TECHNOLOGIES In the South Carolina Room P-213-TH High-Throughput Characterization of Complex Crosslinked Proteins using Byonic and Byologic Chistropher Adams1, Ryan Lieb1, St John Skilton2, Eric Carlson2 1Stanford University, Stanford, CA USA, 2Protein Metrics, Inc., San Carlos, CA USA P-214-TH Protein A Affinity Capture followed By AdvanceBio SEC Aggregation Analysis using the Agilent Infinity Series 2D-LC System Patrick Cronan, Timothy Rice Agilent Technologies, Lexington, MA USA P-215-TH Fast Identification and Quantification Assay for Host Cell Proteins Using Data Independent Acquisition Mass Spectrometric Analysis Catalin Doneanu, Brad Williams, Ying Qing Yu, Weibin Chen, Min Du Waters Corporation, Milford, MA USA P-216-TH Integrating Ion Exchange Based Fractionation into a Glycan Biotheraputic Analysis Workflow Mark Hilliard1, Sinead Hallinan1, Ciara McManus1, Willam Alley2, Ying Qing Yu2, Pauline Rudd1 1NIBRT, Dublin, Ireland, 2Waters Corporation, Milford, MA USA P-217-TH cIEF and CE-SDS Characterization of NISTmAb by Maurice Xin Jiang, Scott Mack ProteinSimple, San Jose, CA USA P-218-TH Analysis of Highly Sialylated and Low-input Glycoprotein Samples on the GlycanAssure™ System Shaheer Khan, Natalee Gautam, Jenkuei Liu, Bharti Solanki-Nand Baburaj Kunnummal, Peter Bell Thermo Fisher Scientific, South San Francisco, CA USA NEW AND EMERGING TECHNOLOGIES In the Rhode Island Room P-219A-TH Development of a 5-Minute Deglycosylation Method and Instant Labeling Dye for High-throughput N-glycan Analysis by Mass Spectrometry Michael Kimzey, Aled Jones, John Yan, Vaishali Sharma, Andres Guerrero, Alexander Gyenes, Justin Hyche, Emily Dale, Ted Haxo, Sergey Vlasenko ProZyme, Inc., Hayward, CA USA

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P-219-TH Rapid PNGase F: Antibody characterization and Serum N-glycan profiling Paula Magnelli, Ellen Guthrie, Stephen Shi New England Biolabs, Inc., Ipswich, MA USA P-220-TH Poly(lactic-co-glycolic acid) Nanoparticles in Cell Media used as Biocompatible Substrates in Pharmaceutical Applications: Comprehensive Characterization with Centrifugal Field-flow Fractionation (CF3) Coupled with Online Dynamic Light Scattering (DLS) Robert Reed1, Soheyl Tadjiki1, Florian Meier2, Markus Spallek2, Silvia Spek3, Klaus Langer3, Thorsten Klein2 1Postnova Analytics Inc., Salt Lake City, UT USA, 2Postnova Analytics GmbH., Landsberg am Lech, Germany, 3University of Münster, Münster, Germany P-221-TH Process Analytical Technology (PAT) for Biologics: Case Studies from Continuous Production Douglas Richardson, Jun Heo, Yi Wang, Bhumit Patel, Mark Brower, David Pollard Merck & Co., Inc., Kenilworth, NJ USA P-222-TH Complementarity Study of the N-linked Glycosylation of a Therapeutic Glycoprotein Laura Salmeron1, András Guttman2 1Halozyme Therapeutics, Inc., San Diego, CA USA, 2SCIEX, Brea, CA USA P-223-TH A Multi-Attribute Mass Spectrometry Method for Adenovirus Based Vaccines Arjen Scholten, Carol Ram, Jonathan Knibbe, Harold Backus, Johan Nijenhuis, Annemiek Verwilligen Janssen Vaccines & Prevention, Leiden, The Netherlands P-224-TH Cryo-EM: A Powerful Tool for Structural Studies of Proteins Natalia de Val, Jeffrey Speir, Joyce Sung, Joel Quispe, Kathy On, Anette Schneemann, Bridget Carragher, Clinton Potter NanoImaging Services, Inc., San Diego, CA USA P-225-TH Analysis of Sialylated N-glycans Using an Optimized HILIC-FLR-MS Method Qi Wang, Matthew Lauber Waters Corporation, Milford, MA USA PROCESS DEVELOPMENT / PROCESS CONTROL In the Pennsylvania Room P-226-TH Enabling Robust Cloning Method Qualification in Cell Line Development Andrea Gough, Ian Taylor Solentim Ltd., Wimborne, United Kingdom

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P-227-TH Analysis of Host Cell Protein using Automated Offline Fractionation and LC-MS/MS Steve Murphy1, Jing Chen2, Zach Van Den Heuvel1, Alex Zhu3 1Agilent Technologies, Madison, WI USA, 2Agilent Technologies, Santa Clara, CA USA, 3Agilent Technologies, Wilmington, DE USA P-228-TH LC-MS Based HCP Monitoring during Biologic Downstream Process Development Chen Li1, Wanlu Qu1, Serah Liu1, Shiaw-Lin Wu1, Fengqiang Wang2, Yan-Hui Liu2, Doug Richardson2, Daisy Richardson2 1BioAnalytix, Inc., Cambridge, MA USA, 2Merck & Co., Inc., Kenilworth, NJ USA P-229-TH Automated Online Monitoring and Quality Control of Glycan Profiles from Various Antibodies Using FabRICATOR Digestion and Subunit Separation in Combination with Ultrahigh-resolution QTOF Mass Spectrometric Analysis and the Latest Biopharma Software Tools Jason Wood1, Detlev Suckau2, Guillaume Tremintin3, Martin Hedström4, Fredrik Olsson5 1Bruker Daltonics, Inc, Billerica, MA USA, 2Bruker GmbH, Bremen, Germany,3Bruker Daltonics, Inc, Fremont, CA USA,4 Capsenze HB, Lund, Sweden, 5Genovis AB, Lund, Sweden

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Roundtable Information

Tuesday, January 24, 2017 14:45 – 15:45

In the Cabinet Room TABLE 1 TOPIC: Process Performance Qualification for Accelerated Products FACILITATOR: Josh Grieco, Genentech, a Member of the Roche Group SCRIBE: Julia O'Neill, Tunnell Consulting TABLE 2 TOPIC: Combination Products - Analytical Challenges FACILITATOR: Pat Rancatore, Genentech, a Member of the Roche Group SCRIBE: Peter Johnson, 3M Drug Delivery Systems TABLE 3 TOPIC: Innovating Purity/Impurity Testing During LCM FACILITATOR: Narasaiah Dontha, Celgene Corporation SCRIBE: Anders Lund, Sanofi TABLE 4 TOPIC: Surrogate Sterility Testing FACILITATOR: Brian Nunnally, Biogen SCRIBE: Allison Lehtinen, Biogen TABLE 5

TOPIC: Analytical Target Profiles FACILITATOR: Amisha Kizhakkedathu, Pfizer, Inc. SCRIBE: Sherry Guo, Genentech, a Member of the Roche Group TABLE 6 TOPIC: Analytical QbD FACILITATOR: Edwin Moore, University of Illinois SCRIBE: Kenneth Miller, MedImmune, A member of the AstraZeneca Group TABLE 7 TOPIC: Analysis of Non-protein Particles FACILITATOR: Santosh Yadav, Merck & Co., Inc. SCRIBE: Samir Sane, Genentech, a Member of the Roche Group

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TABLE 8

TOPIC: Applying Biosimilar Development Approaches to Innovative Products FACILITATOR: Carol Krantz, Sierra Oncology SCRIBE: Jason Rouse, Pfizer, Inc. TABLE 9 TOPIC: Regulatory Requirements for Gene Editing FACILITATOR: Joann Parker, Pfizer, Inc. SCRIBE: Ilona Reischl, AGES-Austrian Federal Office for Safety in Health Care TABLE 10 TOPIC: Forced Degradation as a Part of Comparability FACILITATOR: Tapan Das, Bristol-Myers Squibb Company SCRIBE: Holly Cargill, Pfizer, Inc.

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Tuesday, January 24, 2017 14:45 – 15:45

In the District Ballroom TABLE 11 TOPIC: Antibodies with Effector Function: Development and Comparability Strategies FACILITATOR: Mike Lewis, Janssen Pharmaceutical R&D, LLC SCRIBE: Reed Harris, Genentech, a Member of the Roche Group TABLE 12 TOPIC: The Quality Overall Summary: Making the Best of It FACILITATOR: Allison Wolf, Eli Lilly and Company SCRIBE: Melia Grim, MedImmune, A member of the AstraZeneca Group TABLE 13 TOPIC: Introducing a New Biologic into Your Commercial Facility: Best Practices FACILITATOR: Lou Antinori, Pfizer, Inc. SCRIBE: Gerald DiDonato, Bristol-Myers Squibb Company TABLE 14 TOPIC: Advances in Gene Therapy Manufacturing Platforms FACILITATOR: Francis Poulin, Genzyme, a Sanofi Company SCRIBE: Mike Abernathy, Amgen Inc. TABLE 15 TOPIC: Host Cell Protein: Implementing Risk Assessment Strategies FACILITATOR: Bharat Dixit, Genocea Biosciences, Inc. SCRIBE: Marisa Jones, GlaxoSmithKline TABLE 16 TOPIC: In-use Stability: How to Develop a Plan for Your Product FACILITATOR: Timothy Schofield, GlaxoSmithKline SCRIBE: Jason Starkey, Pfizer, Inc. TABLE 17 TOPIC: Novel Modalities and their Comparability Challenges during Late Stage Development FACILITATOR: James Carroll, Pfizer, Inc. SCRIBE: Nick Bond, MedImmune, A member of the AstraZeneca Group

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TABLE 18 TOPIC: Streamlining In-country Testing Requirements, Transfers, and Post-approval Changes for Global Markets FACILITATOR: Mary Beth Pelletier, Biogen SCRIBE: Justin Aldridge, Biogen TABLE 19

TOPIC: Method Transfers: Industry and Regulatory Perspectives FACILITATOR: Tam Soden, Janssen Pharmaceutical R&D, LLC SCRIBE: John Kim, Teva Pharmaceutical Industries Ltd. TABLE 20 TOPIC: Visible Particulates FACILITATOR: Tami Wu, Seattle Genetics, Inc. SCRIBE: Jackie Moxham, Pfizer, Inc.

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Tuesday, January 24, 2017 14:45 – 15:45

In the Palm Court Ballroom TABLE 21 TOPIC: Polysorbate Degradation: Mechanisms and Implications FACILITATOR: Barthelemy Demeule, Genentech, a Member of the Roche Group SCRIBE: Atanas Koulov, Lonza Biologics TABLE 22 TOPIC: Viral Segregation Practices FACILITATOR: Michelle Wang, Adello Biologics, LLC SCRIBE: Roman Drews, LFB-USA, Inc. TABLE 23 TOPIC: Tech Transfer into Manufacturing: The Initial Risk Assessment FACILITATOR: Weiwei Hu, Celgene Corporation SCRIBE: Patsy Lewis, Seattle Genetics, Inc. TABLE 24 TOPIC: QbD: Value and Challenges FACILITATOR: Lynn Gennaro, Genentech, a Member of the Roche Group SCRIBE: Michael Chang, Shire TABLE 25 TOPIC: Raw/Ancillary Materials: Risk Management and Control FACILITATOR: Maura Kibbey, United States Pharmacopeial Convention SCRIBE: Emily Shacter, ThinkFDA LLC TABLE 26 TOPIC: Preparing for PAI and HA Inspections: Trends and General Guidelines FACILITATOR: Jennifer Eck, MedImmune, A member of the AstraZeneca Group SCRIBE: Cishan (Kevin) Li, CDER, FDA TABLE 27 TOPIC: Shipping and Cold Chain Management FACILITATOR: Kathy Lee, Eli Lilly and Company SCRIBE: Kevin King, Pfizer, Inc.

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TABLE 28 TOPIC: Linking Process Variability and Clinical Experience to Support Establishment of Clinically Relevant Specifications FACILITATOR: J.R. Dobbins, Eli Lilly and Company SCRIBE: Jackie Macaulay, Pfizer, Inc. TABLE 29 TOPIC: Potency Testing for Vaccine Development FACILITATOR: Arjen Scholten, Janssen Vaccines SCRIBE: John Amery, Pfizer, Inc. TABLE 30 TOPIC: Regulatory Expectations and Challenges in China FACILITATOR: Chi-Ting Huang, CTH Analytical Consulting SCRIBE: MingFang Hong, Merck & Co., Inc.

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Roundtable Information

Wednesday, January 25, 2017 16:30 – 17:30

In the Cabinet Room TABLE 31 TOPIC: Assays Used in Process Monitoring: Lifecycle Management FACILITATOR: Julia O'Neill, Tunnell Consulting SCRIBE: Heidi Holovics, Pfizer, Inc. TABLE 32 TOPIC: Fingerprinting Approaches: Impact for Biosimilars and Innovative Products FACILITATOR: Brian DiPaolo, AbbVie, Inc. SCRIBE: Valerie Tsang, Biogen TABLE 33 TOPIC: Post-approval Analytical Comparability: Global Convergence FACILITATOR: Rob McCombie, Genentech, a Member of the Roche Group SCRIBE: Mike Jankowski, Pfizer, Inc. TABLE 34 TOPIC: Novel Modalities: Process and Analytical Challenges FACILITATOR: Jessika Feliciano, Janssen R&D, LLC SCRIBE: Kris Antonsen, BioMarin Pharmaceuticals, Inc. TABLE 35 TOPIC: Method Changes in a Commercial Environment FACILITATOR: Justin Aldridge, Biogen SCRIBE: Mary Beth Pelletier, Biogen TABLE 36 TOPIC: Biosimilars: Ways to Manage Challenges Post-approval FACILITATOR: Patsy Lewis, Seattle Genetics, Inc. SCRIBE: Carmilia Jimenez Ramirez, Gilead Sciences TABLE 37 TOPIC: QbD and Design Space: Post-approval Experiences FACILITATOR: Christof Finkler, F. Hoffman – La Roche Ltd. SCRIBE: Jette Wypych, Amgen Inc.

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TABLE 38 TOPIC: Between Shipping and Administration: What is the Product Quality of the Drug Patients Actually Receive? FACILITATOR: Arun Tholudur, Amgen Inc. SCRIBE: Bryan Silvey, Kite Pharma TABLE 39 TOPIC: ID Testing: Managing Satellite Samples FACILITATOR: Dieter Schmalzing, Genentech, a Member of the Roche Group SCRIBE: Zahra Shahrokh, STC Biologics TABLE 40 TOPIC: Changes to Naming Conventions for mAbs FACILITATOR: Patrick Swann, Biogen SCRIBE: Shadia Zaman, CDER, FDA

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Wednesday, January 25, 2017 16:30 – 17:30

In the District Ballroom TABLE 41 TOPIC: Patient Access: Bringing Biologics to Everyone FACILITATOR: Scott Whitlock, Seattle Genetics, Inc. SCRIBE: Stephen Hadley, Bill & Melinda Gates Foundatioin TABLE 42 TOPIC: Validation of Research Test Kits for QC Lot Release FACILITATOR: Kenneth Miller, MedImmune, A member of the AstraZeneca Group SCRIBE: Maura Kibbey, UnitedStates Pharmacopeial Convention TABLE 43 TOPIC: PAT: Sterile Sampling from Stainless and Disposable Bioreactors FACILITATOR: Jason Starkey, Pfizer, Inc. SCRIBE: Doug Richardson, Merck & Co., Inc. TABLE 44 TOPIC: Control Strategies for Surfactants in Biopharmaceuticals FACILITATOR: Jamie Moore, Genentech, a Member of the Roche Group SCRIBE: Carsten Jahn, AbbVie, Inc. TABLE 45 TOPIC: Multi-attribute Methods (MAM) FACILITATOR: Richard Rogers, Just Biotherapeutics SCRIBE: Mike Abernathy, Amgen Inc. TABLE 46 TOPIC: Reduced Stability Testing Approaches for Biologics/Biotech Products FACILITATOR: Brian K. Nunnally, Biogen SCRIBE: Allison Torgesen, Seattle Genetics, Inc. TABLE 47 TOPIC: Potency Tests for Vaccines: Hard to Develop or Change? FACILITATOR: Sally Seaver, Seaver Associates LLC SCRIBE: Carol Krantz, Sierra Oncology

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TABLE 48 TOPIC: Process Performance Qualification for Accelerated Products FACILITATOR: Trevor Swartz, Genentech, a Member of the Roche Group SCRIBE: Gerald DiDonato, Bristol-Myers Squibb Company TABLE 49 TOPIC: Combination Products / Therapies: Development of Control Strategies FACILITATOR: Sherri Biondi, Genentech, a Member of the Roche Group SCRIBE: Peter Johnson, 3M Drug Delivery Systems TABLE 50 TOPIC: Antibodies with Effector Function: Development and Comparability Strategies FACILITATOR: John Kim, Teva Pharmaceutical Industries Ltd. SCRIBE: William Matousek, Regeneron Pharmaceuticals, Inc.

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Wednesday, January 25, 2017 16:30 – 17:30

In the Palm Court Ballroom TABLE 51 TOPIC: The Quality Overall Summary: Making the Best of It FACILITATOR: Michelle Frazier, Coherus Biosciences SCRIBE: Reed Harris, Genentech, a Member of the Roche Group TABLE 52 TOPIC: Preparing for PAI and HA Inspections: Trends and General Guidelines FACILITATOR: Jessica Snow, Bristol-Myers Squibb Company SCRIBE: Kristen Nickens, CDER, FDA TABLE 53 TOPIC: Linking Process Variability and Clinical Experience to Support Establishment of Clinically Relevant Specifications FACILITATOR: Juliana Kretsinger, Eli Lilly and Company SCRIBE: Kimberly Wolfram, Biogen TABLE 54 TOPIC: Raw Materials: Risk Management and Control FACILITATOR: Sarah Demmon, Eli Lilly and Company SCRIBE: Charles Morgan, Genentech, a Member of the Roche Group TABLE 55 TOPIC: Tech Transfer from R&D into Commercial Manufacturing: The Initial Risk Assessment FACILITATOR: Sid Advant, Celgene Corporation SCRIBE: Christopher Broomell, Takeda Pharmaceuticals North America, Inc. TABLE 56 TOPIC: Viral Segregation Practices FACILITATOR: Roman Drews, LFB-USA, Inc. SCRIBE: Nina Brahme, CDER, FDA TABLE 57 TOPIC: In-use Stability: How to Develop a Plan for Your Product FACILITATOR: Wei Liu, Genentech, a Member of the Roche Group SCRIBE: Sharon (Xiao) Chen, MedImmune, a Member of the AstraZeneca Group

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TABLE 58 TOPIC: Analytical Target Profiles FACILITATOR: Juhong Liu, CDER, FDA SCRIBE: Edwin Moore, University of Illinois TABLE 59 TOPIC: Novel Modalities and Their Comparability Challenges During Late Stage Development FACILITATOR: Andrew Weiskopf, Biogen SCRIBE: Nicholas Bond, MedImmune, A member of the AstraZeneca Group TABLE 60 TOPIC: Host Cell Protein: Implementing Risk Assessment Strategies FACILITATOR: Markus Haindl, F. Hoffman – La Roche Ltd. SCRIBE: James Carroll, Pfizer, Inc. TABLE 61 TOPIC: Ghana Regulatory Opporunities FACILITATOR: Eric Karikari-Boateng, Food and Drugs Authority, Ghana SCRIBE: Fadi Hakki, MedImmune, A member of the AstraZeneca Group

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