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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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2 Well Characterized Biologicals @bioprocess365 #WCBCONF 3
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
2 Well Characterized Biologicals @bioprocess365 #WCBCONF 5
SPONSORS
EXHIBITORS
MEDIA PARTNERS
THANK YOU TO OUR SPONSORS & EXHIBITORS
2 6 www .WCBEvent .com
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
2.00
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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