Case Study: Product Characterization, PK and Immunogenicity Assays for the Development of Biosimilar Trastuzumab
Learning Objectives
- Understand the regulatory testing requirements for biosimilars
- Understand the technical challenges associated with the bioanalysis of trastuzumab
- Learn about bioanalytical and characterization approaches for trastuzumab
- Learn about cell-based assays for evaluating the biosimilarity of trastuzumab
Webinar Description
In assessing the comparability of proposed biosimilar compounds to the innovator counterparts, regulatory agencies have stressed the "totality-of-evidence" approach, which relies on both structural and functional characterization, as well as data from animal and clinical studies. We present as a case study a package of assay methods developed for one such biosimilar, trastuzumab, which will include characterization of target binding, Fc receptor binding and ADCC activity as well as PK and immunogenicity assays to be used in clinical studies. Challenges encountered and approaches taken in the development of these methodologies will be discussed.
Meet the Speakers
 |
John Kamerud, PhD. Dr. Kamerud is Scientific Director at Eurofins' St Charles, Missouri site, where his role is to serve as scientific and technical advisor for both clients and internal teams for development, validation, and application of assays to comply with scientific goals and regulatory requirements. He received his PhD (Biochemistry) in 1987 from the University of Minnesota. Dr Kamerud has over 20 years of experience in the development, validation and implementation of immunoassay methods, holding positions with EMD Millipore, Covance Laboratories and Eli Lilly & Comp |
