On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

Presenter: Todd Lester, Associate Director at BioAgilytix

Co-Hosted with: Bioanalysis Zone

The demonstration of similar immunogenicity is a critical requirement for the demonstration of biosimilarity between a biosimilar candidate and the respective reference product. In their webinar, Mr. Lester discusses what the new AAPS White Paper recommends for immunogenicity assays supporting biosimilars., addressing questions such as:

What are the requirements for immunogenicity assessments of biosimilars?
Why do the FDA and EMA recommend the use of a single, biosimilar-based assay?
How are anti-drug antibody (ADA) assays developed and validated for the support of biosimilar drug development programs?

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Featured Expert

Dr. Jennifer Zemo, Director

Dr. Daniel Worms, Associate Principal Investigator

Dr. Frank Wischnewski, Associate Director

Dave Williams, Vice President, Bioanalytical Operations

Jessica Weaver, Manager II & Bioanalytical Project Manager

Dr. Anne Timmerman, Associate Principal Investigator

Dr. Janett Schwarz, Principal Investigator

David Rusnak, Director, Bioanalytical Operations

Dr. Nathan Rudemiller, Manager I and Bioanalytical Project Manager

Dr. Imke Müller, Director, Principal Investigator

Dr. Michelle Miller, Manager II

Carla Mejia, Manager II

Kathryn Lindley, Vice President, Operations

Todd Lester, Associate Director

Peter Leitner, Automation Lead

Laura Lassen, Director

Jennifer Johnson, Manager I

Dr. Janina Hajek, Principal Investigator

Carla Gibbons, QA Director

Luke Armstrong, Manager II

Dr. Florian Anlauff, Principal Investigator

Krystal Alligood, Associate Director

Anita Simkins, Vice President, Global Quality Assurance

Mike Nicholson, Ph.D., Vice President, Operations

Dr. Linda Robbie, Vice President and General Manager, Boston Operations

Dr. Steven Michael, Senior Vice President and Chief Operating Officer

Dr. Frank Horling, General Manager, Europe

Dr. Marianne Scheel Fjording, Scientific Officer

Dr. Afshin Safavi, Founder & Board Member

Dr. Jim McNally, Chief Scientific Officer

PD Dr. Arno Kromminga, Chief Scientific Advisor

Dr. Chad Briscoe, Chief Scientific Officer

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