September 23-26, 2024,
Hynes Convention Center in Boston, USA
Well Characterized Biologicals Track
Advance your knowledge of analytical strategies, regulatory perspectives, and technology for protein and molecule characterization and comparability of biological products
Analytical Characterization Strategies for ADCs, Bispecifics, Fusion Proteins
Analytical Assay Development for Biopharmaceutical Proteins Using Automated Capillary Electrophoresis (CE) Western Blot
Dong Xu, Ph.D., Senior Scientist, Analytical Development, Biogen Inc.
Characterizing the Physiochemical Impact of Size Variants in an Antibody-Drug Conjugate
Sunnie Kim, Ph.D., Senior Scientist, Analytical Sciences, Seattle Genetics
Analytical Strategies for Bispecific Antibody Manufacturing
Speaker TBA, Genmab A/S
Analytical Characterization Challenges of Site-Specific Antibody Drug Conjugates
Lawrence Chen, M.S., Principal Scientist, Pfizer, Inc.
Late Breaking Presentation
Analytical Methods for Identification and Quantification of Host Cell Proteins
Host Residual DNA Testing: New Paradigms and New Techniques
Musaddeq Hussain, Ph.D., Principal Scientist, Merck & Co., Inc.
Identification and Quantification of HCPs in mAbs, Recombinant Proteins and Biosimilars by Mass Spectrometry
Laura McIntosh, Ph.D., VP Translational Research, Proteomics, Caprion Biosciences Inc.
Late Breaking Presentation
Strategies for Higher Order Structure
Simple NMR Methods for Evaluating HOS of Monoclonal Antibody Therapeutic Quinary Structure
FDA Speaker
Kang Chen, Ph.D., Chemist, CDER – FDA (invited)
CD Spectroscopy of Protein-Dye Complexes as a Characterization Tool for Protein Higher Order Structure
Christopher Sucato, Ph.D., Senior Scientist, Biologics/Biophysical Characterization, Charles River Laboratories
Analytical Methods for Identifying, Monitoring and Controlling Product and Process Variants and Impurities
Analytical Methods in Development: Robust Strategies for Charge Variants, Size-Exclusion Methods and other Methods
Elisabeth Krug, Ph.D., Principal Research Scientist, Eli Lilly and Company
Leveraging a Mass Spectrometry Based Multi-Attribute Method Platform for Monitoring Product Variants and Impurities
Trina Mouchahoir, Ph.D., Research Chemist, Biomolecular Measurement Division, National Institute of Standards and Technology (NIST)
Characterization of Antibody Charge Variants Induced by Metal-Catalyzed Oxidation
Yi Yang, M.S., Senior Scientist, Genentech, Inc.
Case Studies of Protein Characterization and Product Comparability
Overview of Analytical Characterization Methods Used to Demonstrate Comparability of Hepatitis A Vaccine
Mary Latza, M.S., Associate Director, Technical Services, Merck & Co., Inc.
Product Comparability Case Study
Speaker TBA, ImmunoGen
Case Studies of USP’s Compendial Approach to the Analysis of Biotherapeutics
Kevin Carrick, Ph.D., Senior Scientific Liaison, Global Biologics, United States Pharmacopeia
Analytical Strategies for Stability Studies for Diverse Products
Considerations for In-Use Stability Studies for Monoclonal Antibody Therapeutics
Suzanne Hudak, M.S., Scientist, Medimmune
Late Breaking Presentation
Biosimilar Characterization and Comparability
Structural and Functional Studies of Infliximab and ABP 710 Biosimilars
Renuka Sivendran, Ph.D., Principal Scientist, Biosimilars Process Development, Amgen Inc.
Using Stability Descriptors and Biophysical Predictors for Successful Biosimilar Formulation Development and Characterization
Hiten Gutka, Ph.D., Principal Scientist, Formulation Development, Oncobiologics Inc.
New Techniques for Characterization of Glycoprotein Drug Products
Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia
Meet the Scientific Advisory Board:
- John Alvino, Senior Manager, Global RA-CMC, GRAPSQA, AstraZeneca
- Luke Arbogast, Ph.D., Research Chemist, Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology
- Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia
- Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology
- Darryl Davis, Ph.D., Associate Director, Analytical, Janssen R&D LLC
- Zhenyu Gu, Ph.D., Scientist III, Global Analytical and Pharmaceutical Development, Alexion Pharmaceuticals
- Suzanne Hudak, M.S., Scientist, Formulation Sciences, Medimmune
- Nomalie Jaya, Ph.D., Principal Scientist, Analytical Sciences, Seattle Genetics, Inc.
- Ho-Young Lee, Ph.D., Scientist, ADQC/Biological Technologies, Genentech, Inc.
- Ranjini Kaushik, Ph.D., Senior Scientist, Attribute Sciences, Process Development, Amgen Inc.
- Carol Shultz, Ph.D., Associate Principal Scientist, Merck & Co.
- Renuka Sivendran, Ph.D., Principal Scientist, Amgen Inc.
- Rosemary J. Versteegan, Ph.D., CEO, International Serum Industry Association
- Xiaobin Xu, Ph.D., Staff Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.
- Santosh Yadav, Principal Scientist, Merck Manufacturing Division, Merck & Co.
- Yi Yang, MSc., Senior Scientist, Genentech, Inc.