Webinars

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

Daniel Worms, Ph.D. Associate Principal Investigator — Daniel Worms,
Ph.D. Associate Principal Investigator

Todd Lester Associate Director — Todd Lester
Associate Director

Nathan Rudemiller Ph.D. Associate Director — Nathan Rudemiller
Ph.D. Associate Director

Jennifer Zemo Ph.D. Director — Jennifer Zemo
Ph.D. Director

Jessica Weaver Manager II & Bioanalytical Project Manager — Jessica Weaver
Manager II & Bioanalytical Project Manager

Krystal Alligood Associate Director — Krystal Alligood
Associate Director

Laura Lassen Director — Laura Lassen
Director

Luke Armstrong Ph.D. Manager II — Luke Armstrong
Ph.D. Manager II

Michelle Miller Ph.D. DABT Associate Director — Michelle Miller
Ph.D. DABT Associate Director

Jennifer Johnson Manager I — Jennifer Johnson
Manager I

Jennifer T. Durham Ph.D. Associate Director of Scientific Services, BioAgilytix — Jennifer T. Durham
Ph.D. Associate Director of Scientific Services, BioAgilytix

Jeff Patrick Ph.D. Director of GMP Operations, BioAgilytix — Jeff Patrick
Ph.D. Director of GMP Operations, BioAgilytix

Janina Hajek Ph.D. Principal Investigator — Janina Hajek
Ph.D. Principal Investigator

Janett Schwarz Ph.D. Principal Investigator — Janett Schwarz
Ph.D. Principal Investigator

Imke Müller Ph.D. Director, Principal Investigator — Imke Müller
Ph.D. Director, Principal Investigator

Carla Gibbons Senior QA Director — Carla Gibbons
Senior QA Director

Carla Mejia Manager II — Carla Mejia
Manager II

Daniel Worms Ph.D. Associate Principal Investigator — Daniel Worms
Ph.D. Associate Principal Investigator

David Rusnak Director Bioanalytical Operations — David Rusnak Director
Bioanalytical Operations

Florian Anlauff Ph.D. Principal Investigator — Florian Anlauff
Ph.D. Principal Investigator

Frank Wischnewski Ph.D. Associate Director — Frank Wischnewski
Ph.D. Associate Director

Anita Simkins Senior Vice President, Global Quality Assurance — Anita Simkins
Senior Vice President, Global Quality Assurance

Anne Timmerman Ph.D. Associate Principal Investigator — Anne Timmerman
Ph.D. Associate Principal Investigator

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