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Bioassays have been an area of contention and discussion for decades. The understanding of the relationship between potency, biological activity and mechanism of action always seems to lead to dialogue with regulators, even today…
A bioassay case study summarizing the challenges in setting the control system of a combination product of two highly similar monoclonal therapeutic antibodies targeting the same cellular antigen: from similar modes of action and synergistic effect to the control of each molecule bioactivity in vit…