Ulrike Herbrand, Charles River Biologics Testing Solutions, Max-Planck-Str. 15A, 40699 Erkrath, Germany

Bioactivity assays are a central and critical requirement for all biopharmaceutical products throughout product development and manufacturing and they should reflect the mechanism of action (MoA). The bioactivity of a test item is estimated by measurement of the biological response that it produces compared to the reference item and data are analyzed using methods of biostatistics.

Bioactivity assays are needed to ensure continued quality, safety and efficacy. Therefore they need to be reliable and standardized with regards to equipment material and procedure and they need to fulfill the guideline requirements for method validation.