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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: