Bioassay development is one of the most challenging aspects of biotherapeutic development. These tests are vital to providing an accurate picture of potency, stability, and biological activity. But bioassay development can be complex and expensive — and often test results can vary. Cell-based bioassays especially lack robustness. In March 2020, the Biopharmaceutical Emerging Best Practices Association (BEBPA) presented its annual bioassay conference in virtual format. Here, BPI’s senior technical editor reports on the conference’s discussions. Read on to learn more about statistical strategies, assay variation and validation, potency and precision, and the relationships between bioassayists and statisticians in the modern bioanalytical laboratory.
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