Bioassay Challenges
Posted on September 9, 2024
Dr. Ulrike Herbrand, Sc Dir GLBL in vitro Bioassays, Charles River Laboratories, Vice-Chair ECA ATMP Interest Group
Bioassays are used to determine the critical quality attribute (CQA) bioactivity/potency of biopharmaceutical products. They shall reflect the mechanism of action (MoA), therefore bioassays are individual for each product but still need to fulfill all regulatory requirements. General Considerations ...
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