The Summit’s 2023 Analytical & Quality stream offers in-depth updates on critical steps in biopharmaceutical development that impact product quality, safety, and regulatory compliance. Separate two-day meetings in this stream will focus on the detection, analysis and removal of host cell proteins and the acceleration of analytical development steps and timelines. Over thirty in-depth presentations will give attendees insight into the best practices being applied across large and small industry R&D groups.

Conferences Include:

Keynote Presentations:

A Journey through the Evolution of HCP Detection Methods: From Early Commercial ELISA Kits to Specific Assays
Nisha Palackal, PhD, Director, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Standard-Free Absolute Quantitation of Antibody Deamidation Degradation and Host Cell Proteins by Coulometric Mass Spectrometry
Hao Chen, PhD, Professor, Chemistry and Environmental Science, New Jersey Institute of Technology

How to Align the Definition of “Compendial Method” with Speed of Innovation?
Elena A. Smith, PhD, Analytical CMC Leader – Vaccine, Sanofi