Topic:

A critical task in biologics manufacturing is the control of process-related impurities such as host cell proteins (HCPs), which co-purify with the drug substance and are known for adverse effects such as immunogenicity. For decades, the method of choice to detect HCPs has been an immunoassay based on polyclonal antisera raised against a population of HCPs. There are some risk factors associated with this approach, and the final performance of the assay depends on the preparation work and materials used at the start.

This seminar will highlight critical parameters throughout the assay development process and introduce new technology which provides targeted enhancement of coverage and maximizes the assay performance.

Speaker:

Dr. Olaf Stamm, MDRA
Olaf Stamm works as a Senior Specialist for analytical and regulatory consulting in the Biologics Testing Solutions division at Charles River. He received his doctoral degree in molecular parasitology and master\’s degree in drug regulatory affairs from the University of Bonn, Germany.

Raffle:
$100 Amazon Gift Card