EVENT GUIDE

General Information . . . . . . . . . . . . . . . . . . . 3

Exhibitor List and Hall Map . . . . . . . . . . . . . . 4

Advisory Boards . . . . . . . . . . . . . . . . . . . . . . 4

Event Sponsors . . . . . . . . . . . . . . . . . . . . . . . 5

Poster Presentations . . . . . . . . . . . . . . . . . 11

Conference AgendaMonday Conference Sessions . . . . . . . . . 6-7

Tuesday Conference Sessions . . . . . . . . . 8-9

Wednesday Post-Conference Workshops . 10@bioprocess365 #WCBCONF

WHAT’S INSIDE

November 11-13, 2019 Hyatt Regency Reston, Reston, VA

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DOWNLOAD THE WELL CHARACTERIZED BIOLOGICS AND BIOLOGICAL ASSAYS MOBILE APPAll registered attendees receive access to the Well Characterized Biologics and Biological Assays networking app, which allows you to view the full attendee list, schedule meetings and create a customized agenda. Instructions:

• Search KNect365 in the iTunes App Store or Google Play Store

• Enter in Well Characterized Biologics & Biological Assays as the event app you wish to access

• Once at the login page, enter your username and password• Complete ‘Retrieve Login Credentials” if you forget your password• Visit us at the Registration Desk with any questions

Admission Admission is limited to persons actively engaged in protein drug discovery and therapeutics, bioconjugates, and cell line development and engineering. 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, November 11: 7:30 am – 5:45 pmTuesday, November 12: 7:15 am – 5:00 pmWednesday, November 13: 8:00 am – 4:30 pm

Exhibit Hall Hours Monday, November 11: 10:10 am – 5:45 pmTuesday, November 12: 9:45 am – 3:30 pm

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.

Badge ScanningExhibitors and organisers may request to scan your badge. This will provide them with your name and basic business card information. By having your badge scanned you consent to your business card information being passed to 3rd parties, but only those that are present at the event, this is unless you have specifically opted out during registration. If you do not have a badge or do not have access to a particular room or area, a member of staff will escort you to the Registration Desk and assist you with upgrading your Registration.

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 Well Characterized Biologics and Biological Assays conference fully support the Americans with Disabilities Act. If you require assistance of any kind, please inquire at the Registration Desk.

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 Login: @Hyatt_Meetings Password: knect19

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

Join KNect365 Life Sciences’ on LinkedIn -- Become a member of BioProcessing Professionals

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 or at any pull station located through out the venue.

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

We assembly out the front or back door depending on where you are located at time of alarm.

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

Please be responsible when plugging laptop and mobile chargers into sockets

GENERAL INFORMATION

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Exhibitor ListAgilent . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Beckman Coulter Life Sciences . . . . 21

Bruker BioSpin . . . . . . . . . . . . . . . . . . 12

Caprion Biosciences Inc . . . . . . . . . . . . 5

GE Healthcare . . . . . . . . . . . . . . . . . . . 18

Intertek . . . . . . . . . . . . . . . . . . . . . . . . 11

KBI BioPharma . . . . . . . . . . . . . . . . . . . 3

PerkinElmer . . . . . . . . . . . . . . . . . . . . . 1

Phenomenex . . . . . . . . . . . . . . . . . . . . 19

RedShift Bioanalytics . . . . . . . . . . . . 25

Sciex . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Synthace . . . . . . . . . . . . . . . . . . . . . . . 24

Thermo Fisher Scientific . . . . . . . . . . 13

Wyatt Technology . . . . . . . . . . . . . . . . 2

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ENTRANCE12 2425

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Poster Boards

Rebook Sales Booth

Well-Characterized Biologics John Alvino, Senior Manager, Global RA-CMC, GRAPSQA, AstraZeneca

Huijuan Li, Ph.D., Head, Analytical Development, Moderna Therapeutics

Jihong Wang, Ph.D., Director, Analytical Sciences, Viela Bio

Darryl Davis, Ph.D., Associate Director, Analytical, Janssen R&D LLC

Renuka Sivendran, Ph.D., Director, Analytical Development, Five Prime Therapeutics

Xiaobin Xu, Ph.D., Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.

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

Biological Assays Aled Jones, Senior Product & Applications Manager, AgilentAlois Hodel, Bioassay Expert, Ipsen Anton Stetsenko, Associate Director, Bioassay, ADC Therapeutics Darryl Davis, Associate Director, Janssen Emma Reyes, Senior Scientist, Pfizer Isam Qahwash, Manager, Bioassay Development, Bristol-Myers Squibb Julie Smith, Senior Manager, Quality Control Biochemistry and Bioassay, Bluebird BioKenneth Miller, Principal Scientist, AstraZeneca Maura Kibbey, Senior Scientist, USP Mindy Wan, Director Business Development, KBI Nancy Sajjadi, Consultant Vijay Chhajlani, Senior Director, Analytical Development, Jounce Vineetha Jayasena, Principal Scientist, Amgen Nadine Ritter, Ph.D., President & Analytical Advisor, Global Biotech Experts

SCIENTIFIC ADVISORY BOARDS

EXHIBIT HALL FLOOR PLAN

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SPONSORS

EXHIBITORS

MEDIA PARTNERS

THANK YOU TO OUR SPONSORS & EXHIBITORS

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MONDAY, NOVEMBER 11, 2019 – MAIN CONFERENCE

7.30 Breakfast, Coffee and Registration

PLENARY SESSION (Grand Ballroom AB)8:30 Chairperson’s Opening Remarks

Cheng-Hong Wei Global Regulatory Affairs, CMC, AstraZeneca

8:40 Characterization Strategies For Novel Modalities Johnson Varghese, Ph.D., Executive Director, Head of Analytical Development & Clinical QC, Celgene

9:10 Analytical Considerations for Cell & Gene Therapy Products Development - An Industry Perspective Debaditya Bhattacharya, Group Leader, Analytical Development, Bluebird Bio

9:40 CMC Quality Practices and Data Integrity for Analytical Labs: Risks and Benefits Nadine Ritter, Ph.D., President & Analytical Advisor, Global Biotech Experts

10:10 Networking and Refreshment Break in Poster and Exhibit Hall

Track A: Analytical Methods & Strategies for

Novel Modalities

Track B: Biological Assays: Accelerating

Timelines for Bioassay DevelopmentGrand Ballroom A Grand Ballroom B

10.40 Chairperson’s RemarksJohn Alvino, Director, Regulatory CMC, AstraZeneca

Chairperson’s RemarksEmma Reyes, PhD, MBM, Senior Scientist, Pfizer

10:45 Analytical Control Strategy for mRNA based VaccinesFrank Zhang, Ph.D., Senior Manager, Molecular Analytics, ARD/TRD

Development of a Potency Assay to Measure Antibody Dependent Cell Mediated Phagocytosis (ADCP) of a Protein Aggregate Cullen Mason, Scientist II, Biogen

11.15 Meeting Analytical Challenges for Characterization of AAV Gene Therapy ProductsWei Zhang, Ph.D., Principal Scientist, Biogen

Development, Validation and Automation of a Robust Cell Potency Assay for a Multi-Target mAb: Cytokine Therapeutic Drug Karla Kopec, Principal Scientist, Teva Pharmaceuticals

SPONSORED TRACK PRESENTATION (Grand Ballroom A)11.45

Proven Answers for Protein, Vaccine and Gene Therapy Analysis

Mukesh Malik, Ph.D., Senior Application Scientist, Sciex

LUNCHEON ROUNDTABLE DISCUSSIONS in Poster and Exhibit Hall

No PowerPoint slides here! Join interactive discussion around your challenges, roadblocks, ideas, and solutions to the biggest issues in characterization and bioassay development!

12.15 TABLE A: Product CQA Assessment and BLA FilingModerator: Boxu Yan, Acceleron Pharma

TABLE B: Host Cell Protein Impurities Moderator: Mindy Wan, Director, KBI Biopharma

TABLE C: Identifying and Monitoring Glycosylation Critical Quality Attributes (GCQAs) for Biopharmaceuticals Moderator: Radoslaw Kozak, Ph.D., Head of Glycoprofiling Analytical Services, Ludger Ltd.

TABLE D: Setting Release Specifications to Ensure Product QualityModerator: Renuka Sivendran, Ph.D., Director Analytical Development, Five Prime Therapeutics

TABLE E: Bioassay Validation and Data AnalysisModerator: Larry Liu, Ph.D., Scientist, Five Prime Therapeutics

TABLE F: Regulatory Challenges with Personalized MedicineModerator: Shy Bhattacharya, Ph.D., Associate Science & Standards Liaison, United States Pharmacopeia

TABLE G: Incorporating Automation into BioassaysModerator: Jean Husten, Principal Scientist, Bioassay Biosciences Group, Teva Pharmaceuticals

Well Characterized Biologicals @bioprocess365 #WCBCONF 7

MONDAY, NOVEMBER 11, 2019 – MAIN CONFERENCE

Track A: Analytical Methods & Strategies for

Novel Modalities

Track B: Biological Assays: Accelerating

Timelines for Bioassay DevelopmentGrand Ballroom A Grand Ballroom B

1.10 Chairperson’s RemarksJohn Alvino, Director, Regulatory CMC, AstraZeneca

Chairperson’s RemarksEmma Reyes, PhD, MBM, Senior Scientist, Pfizer

1:15 Learning from Biologics Development to Support New Molecules Qin “Chinn” Zou, Ph.D., A.R. Fellow, Analytical R&D, Pfizer

PANEL DISCUSSION: Phase Appropriate Bioassay Strategy Cheng-Hong Wei, Global Regulatory Affairs CMC, AstraZenecaKarla Kopec, Principal Scientist, Teva Pharmaceuticals

1:45 CASE STUDY: Charge Variant Analysis of Complex BiotherapeuticsQi Wang, Ph.D., Scientist II, Method Development, Biologics Development, Bristol-Myers Squibb

An Improved CHO HCP Detection System for Biopharmaceuticals Mindy Wan, Ph.D., Director, KBI Biopharma

CONCURRENT TECHNOLOGY WORKSHOPS 2:15

(Grand Ballroom A)An insight into Validation of a Fc binding - SPR assay using a Biacore T200Sethu Alexander, Manager of Biacore, BioOutsource Ops II, Sartorius Stedim Biotech

(Grand Ballroom B)MALS, DLS, FFF: Essential Analytical Tools for Novel ModalitiesAndrew Meyer, Ph.D., Southeast Regional Manager & Senior Applications Scientist, Wyatt Technology

2:45 Networking and Refreshment Break in Poster and Exhibit Hall

Track A: Analytical Characterization –

Accelerating Method Development to Expedite Timelines

Chairperson: Chun Shao, Ph .D ., Scientist II, Bristol-Myers Squibb

Track B: Biological Assays: Achieving a Robust

Assay Across Labs & Phases

Grand Ballroom A Grand Ballroom B

3:30 Smart Strategies to Accelerate Analytical Timelines to Support Biologics Development and CommercializationSantosh Yadav, Ph.D., Principal Scientist, Merck Manufacturing Division

QbD for Bioassay Development, Guided by the Analytical Target Profile Ryan Yamagata, M.S., Vaccines CMC Statistical Sciences, GlaxoSmithKline

4.00 PANEL DISCUSSION: Early vs . Late Stage – How to Accelerate Analytical Timelines for BiologicsModerator: Santosh Yadav, Ph.D., Principal Scientist, Merck Manufacturing DivisionPanelists: Tatyana Mezhebovsky, Ph.D., A.L.M., Associate Director, Pharmaceutical Development, Alexion PharmaceuticalsLe Meng, Ph.D., Senior Scientist, Entrada TherapeuticsJihong Wang, Ph.D., Director, Analytical Sciences, Viela Bio

USP Standards to Support Potency Measurements Maura Kibbey, Ph.D., Senior Scientific Fellow, US Pharmacopeia

4:45 Networking Cocktail Reception in Poster and Exhibit Hall

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TUESDAY, NOVEMBER 12, 2019 – MAIN CONFERENCE

7.15 Breakfast, Coffee and Registration

PLENARY SESSION (Grand Ballroom AB)7:55 Chairperson’s Opening Remarks

Renuka Sivendran, Ph.D., Director, Analytical Development, Five Prime Therapeutics

8:00 Analytical Development of Allogeneic CAR-TsMichael Bowen, Ph.D., Process and Product Development, Allogene Therapeutics

8:30 Regulatory Perspectives on Biological Assays for CAR-T Cell Products Graeme Price, Ph.D., Research Microbiologist, Office of Tissues and Advanced Therapeutics (OTAT), CBER – FDA

FDA SPEAKER

9:00 PANEL DISCUSSION: R&D Lab Quality and Data IntegrityModerator: Nadine Ritter, Ph.D, President and Analytical Advisor, Global Biotech Experts, LLC

Panelists: Johnson Varghese, Ph.D., Executive Director, Head of Analytical Development and Clinical QC, Biologics, Celgene Michael Sadick, Ph.D., Principal Scientist, Catalent Pharma Solutions

Michael Merges, Director of Analytical Sciences & Technology, Emergent BioSolutions

9:45 Networking and Refreshment Break in Poster and Exhibit Hall

Track A: Analytical Characterization –

Regulatory Perspectives from Industry

Track B: Biological Assays: Applying Current

Technologies For Bioassay OptimizationGrand Ballroom A Grand Ballroom B

10.10 Chairperson’s RemarksRenuka Sivendran, Ph.D., Director, Analytical Development, Five Prime Therapeutics

Chairperson’s RemarksJessica Townsend, Critical Reagent Manager, Quality Science & Technology, BlueBird Bio

10:15 Tying Analytical Strategy to Control Strategy for CMC Manufacturing John Kim, Director, Analytical Sciences, Biologics R&D, Teva Pharmaceuticals

Strategic ways to meet bioassay performance requirements with modular design and analysesDavid Lansky, President and Principal Statistician, Precision Bioassays

10.45 PANEL DISCUSSION: CMC Packages – How to Utilize What We Know from Traditional Comparability Studies to New ModalitiesModerator: Renuka Sivendran, Ph.D., Director, Analytical Development, Five Prime Therapeutics, Inc.Panelists: John Alvino, Director, Regulatory CMC, AstraZenecaLe Meng, Ph.D., Senior Scientist, Entrada Therapeutics

How To Combine ICHQ2 and USP Principles of Bioassay Method Validation for In Vitro Potency Assays Nadine Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

11.15 Build an Automation Platform for Bioassays Yu-Chih (Jay) Hsu, Scientific Investigator, GSK

SPONSORED TRACK PRESENTATIONS11.45

(Grand Ballroom A)Characterization of Host Cell Proteins by Mass Spectrometry throughout the Product Life Cycle John Babetas, Senior Principal Scientist, Caprion Biosciences

(Grand Ballroom B)Biologic CQA Assessment Using Validated High-Throughput SPR AssaysMichael Murphy, Ph.D., Biacore Application Scientist, GE Healthcare Life Sciences

12.15 Networking Luncheon in the Exhibit and Poster

Well Characterized Biologicals @bioprocess365 #WCBCONF 9

TUESDAY, NOVEMBER 12, 2019 – MAIN CONFERENCE

Track A: Analytical Characterization –

Glycan and Glycosylation Analysis Methods

Track B: Biological Assays: Overcoming

Challenges with In House Bioassays and Critical Reagent Management

Grand Ballroom A Grand Ballroom B1.25 Chairperson’s Remarks

Shy Bhattacharya, Ph.D., Associate Science & Standards Liaison, United States Pharmacopeia

Chairperson’s RemarksJessica Townsend, Critical Reagent Manager, Quality Science & Technology, BlueBird Bio

1:30 Case Study: Characterization of Glycation in an IgG1 by CE-SDS and Mass Spectrometry Boxu Yan, Ph.D., Sr. Director, Acceleron Pharma

Critical Reagents: Selection and Qualification to Ensure Successful Analytical Testing Jessica Townsend, M.Sc., Critical Reagent Manager, Quality Science and Technology, Bluebird Bio, USA

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Monitoring of Glycosylation Using Site Specific ApproachesMichael Walker, Technical Expert, Intertek Pharmaceutical Services

Optimizing Critical Reagent Manufacture for Consistency: Understanding the Impact of Production Parameters and Bioassay PerformanceJodi Pegg, Principal Scientist, Pfizer

CONCURRENT TECHNOLOGY WORKSHOPS 2.30

(Grand Ballroom A)N-Glycan Sample Preparation, Analysis and Characterization Workflows for Biotherapeutic GlycoproteinsJohn Yan, Ph.D., Applications Scientist, Agilent Technologies

(Grand Ballroom B)Quality Assessment of Biologics and Biosimilars at Atomic Resolution Anna Codina, Ph.D., Director, Pharmaceutical Business Unit, Bruker BioSpin

3.00 Networking and Refreshment Break in Poster and Exhibit Hall

Track A: Analytical Characterization – Novel Technologies for Characterization

Track B: Development for Challenging

ModalitiesGrand Ballroom A Grand Ballroom B

3:30 Emerging Mass Spec Trends in Analysis of BiopharmaceuticalsIgor Kaltashov, Ph.D., Professor, University of Massachusetts Amherst

Bioassay Strategy for Complex Molecules Emma Reyes, Phd, MBM, Senior Scientist, Pfizer, Inc

4.00 Characterization and Quantification of Succinimide Using Peptide Mapping Under Low-pH Conditions and Hydrophobic Interaction ChromatographyMingyan Cao, Ph.D., Senior Scientist II, Analytical Biochemistry, MedImmune

Streamlining Your Bioassay Lifecycle for BispecificsRajeev Boregowda, Scientist II, Celgene

4.30 PANEL DISCUSSION: Analytical Innovation – A Pathway Paved by mAbs and its Prospects for Emerging ModalitiesModerator: John Schiel, Ph.D., Research Chemist, IBBR, National Institute of Standards and TechnologyPanelist: Chun Shao, Ph.D., Scientist II, Commercial Method Development, Biologics Process Development, Global Product Development & Supply, Bristol-Myers Squibb Qin ‘Chinn’ Zou, Ph.D., A.R. Fellow, Analytical R&D, Pfizer

Track Ends

5:15 Close of Main Conference – See you in 2020!

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Well Characterized Biologics& Biological Assays

SEE YOU NEXT YEAR

October 27-29, 2020 | College Park Marriott Hotel & Conference Center, Hyattsville, MD

WEDNESDAY, NOVEMBER 13, 2019 – POST-CONFERENCE WORKSHOPS 8:55 am-5:00 pm

Workshop 1: The Evolution of Monoclonal Antibodies: Best Practices and Lessons Learned 30+

Years in the Making

Workshop 2: DoE Based Approaches in Bioassay Development & Bioassays for Beginners

Workshop 3: Bioassays For Beginners

Grand Ballroom E Grand Ballroom F Grand Ballroom G

8:55 Chairperson’s RemarksKevin Zen, Ph.D., Executive Director, Analytical Characterization, Formulation Development, QC Stability, and DP Technical Operations, AnaptysBio

9:00 Analytical Control Strategies of Characterizing Product and Process Impurities for Monoclonal Antibody Therapeutics: Lessons LearnedKevin Zen, Ph.D., Executive Director, Analytical Characterization, Formulation Development, QC Stability, and DP Technical Operations, AnaptysBio

10:30 Networking Refreshment Break 11:00 Kevin Zen, Ph.D., continued 12:30 Networking Lunch 1:45 Pathway for Robust Implementation of

Higher Order Structure Assessment of Monoclonal Antibody Therapeutics by 2D-NMRRobert Brinson, Ph.D., Research Chemist, Institute for Bioscience and Biotechnology, National Institute of Standards and Technology

2:15 Microbial Challenge of Biotherapeutics Drug Product IV admixtures: Why, What and How to TestTatyana Mezhebovsky, Ph.D., A.L.M., Associate Director, Pharmaceutical Development, Alexion Pharmaceuticals

2:45 Networking Refreshment Break 3:15 Evaluation of the Multi-Attribute Method:

An Industry-wide Case StudyTrina Mouchahoir, Ph.D., Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology

4:00 Developing Physical Standards to Calibrate Assay Methods for mAbs Including cIEFShy Bhattacharya, Ph.D., Associate Science & Standards Liaison, United States Pharmacopeia

David Lansky, Ph.D., President and Principal Statistician, Precision Bioassay, Inc.

Workshop Overview:Content TBC

Who should attend?Scientists, Managers and Directors in:• CMC Bioassay Development, Assay Innovation• Analytical R&D• CMC• Protein Analytical Chemistry • Product Characterization • Statistics • Biological Development and Biological Technologies• Bioanalytics• Regulatory Affairs, QA/QC

Workshop Timings: 9:00 Start

10.30 Networking Refreshment Break

12.30 Lunch

2.45 Networking Refreshment Break

5:00 Finish

Michael Sadick, Principal Scientist, Catalent Pharma SolutionsMichael Merges, ESBI

Workshop Overview• Characterizing a ‘well characterized product• Basic tool kit – very specific to bioassays and

training scientist – any equipment? • Designing Bioassays • Regulatory Expectations • Data Analysis/ System Suitability and Acceptance

Criteria • Bioassay transfer • Data Trending: Good, Bad and Ugly • Global Approach to Bioassays • Case Study I• Case Study II• Lessons Learned

Workshop Timings: 9:00 Start

10.30 Networking Refreshment Break

12.30 Lunch

2.45 Networking Refreshment Break

5:00 Finish

8:00 Breakfast, Coffee and Registration

Well Characterized Biologicals @bioprocess365 #WCBCONF 11

1 Detection of AAV Capsid Proteins by CE-SDS as an Alternative to Silver Stain SDS-PAGE April Blodgett PerkinElmer

2 Isolation and Characterization of Charge, Size, and Hydrophobic Interaction Chromatography Variants for Antibody Drug Conjugates to Support Critical Quality Attribute (CQA) Assessment

Aron Lee Genentech

3 Illuminating virus neutralizing titers and antigen potency: A robust, 24-hour assay based on recombinant virus expressing Firefly Luciferase

Ben Clarke GSK Vaccines

4 Platform DoE Approach for Fusion Protein Charge Heterogeneity Analysis Caleen Dayaratna Patheon, part of Thermo Fisher Scientific

5 Cation Exchange Chromatography Particle Development and Application in Charge Variant Analysis

Chad Eichman Phenomenex

6 Understanding of Self Assembly of Heavy and Light Chains without Disulfide Bonds: Use of Denaturing SEC Method as an Orthogonal Method to CE-SDS NR

Guoyong Sun Bristol-Myers Squibb

7 Rapid Workflows for N-Glycan Sample Preparation and Analysis of Biotherapeutics Using InstantPC and 2-AB with LC-FLD-MS

John Yan Agilent

8 Streamlined High Performance Extraction and Quantitation of Host Cell Residual DNA Kaushik Nama Thermo Fisher Scientific

9 Development and Qualification of a Complex Assay Laura McAleer Sartorius Stedim Biotech

10 More than a-helix and -sheet: expanding the role of circular dichroism Marc Neglia Applied Photophysics

11 Pressure-perturbation of protein secondary structure coupled with Microfluidic Modulation Spectroscopy – a powerful platform for biopharmaceutical formulations development .

Matthew McGann RedShift Bioanalytics

12 Epitope binning analysis for further differentiation of therapeutic antibodies and diagnostic reagents

Michael Murphy GE Healtcare

13 Characterization of Adeno-Associated Virus (AAV) Using Capillary Electrophoresis Mukesh Malik Sciex

14 An Analytical Revolution: Introducing the Next Generation Optima AUC Olga Di Guida Beckman Coulter Life Sciences

15 Case studies of CQA assessment with bioanalytical strategy for biotherapeutics Ping Carlson Celgene

16 “Do it Right the First Time” Approach to Efficient Formulation Development in Early Phase Drug Product Development

Pooja Desai Therapure Biopharma

17 Analysis of Glycosylation Critical Quality Attributes (GCQAs) of monoclonal antibody (mAb) therapeutics

Radoslaw Kozak Ludger Ltd

18 N-Glycosylation customization of rituximab using the FastPharmingTM system Roman Subbotin iBio

19 Flexible Automated Design of Experiments:Applications in Bioprocessing & Analytical Development

Tiffany Montgomery

Synthace

20 Rapid, automated execution of high-dimensional space filling DoE for assay development Tiffany Montgomery

Synthace

21 A Next-Generation Platform Size Exclusion Chromatography (SEC) method Development for a Broad range of Monoclonal Antibodies

Vandana Chandrasekar

Bristol-Myers Squibb

22 Qualification of a Cell Count Method for Production of IDCT, A Cell Therapy for Disc Degeneration Will Heaton DiscGenics

23 Development of New USP Reference Standards: Characterization of Three Monoclonal Antibodies by cIEF

Zhiwen Yang USP

POSTER PRESENTATIONS

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