MoA Reflecting Bioassays to Confirm Biosimilarity

Bioactivity testing requirements recently changed from later phase lot release and stability testing to applications like biocomparability testing for biosimilars, accelerated stress condition testing and confirmation of successful scale up of production. More than one suitable bioassay is often required at an early time point since drugs like therapeutic antibodies follow more than one MoA. Assays used need to be reliable, reproducible and precise, which is reflected by rising acceptance of surrogate approaches due to primary MoA assays being time consuming and sometimes highly variable.

This webinar reviews case studies for therapeutic antibodies including classical immunological MoA assays, such as ADCC, CDC and ADCP.

Presenter

  • Ulrike Herbrand, PhD, Scientific Supervisor R&D, Biosafety & Bioassay Services, Charles River


Please see the links below for the other webinars in the series:

Use of CROs to Speed the Development of Biosimilars

The Role of Mass Spectrometry in Demonstrating Biosimilarity

Nonclinical and Clinical Bioanalytical Assay Requirements for Biosimilar Drug Development