Module 9 2021

24/03/2021

What are Bioassays used for?

Variety of purposes: • Screening for active compounds (Pre-clinical) • Pre-clinical efficacy (early development) • Pharmacokinetics

• Immunogenicity – desired and unwanted effects • Routine batch release testing (Phase III/Commercial) • Stability indicating (Phase III/Commercial)

The Organisation for Professionals in Regulatory Affairs

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Why bioassays?

• Physicochemical tests alone cannot characterize the molecule sufficiently to predict biological activity “assessment of the biological properties constitutes an essential step in establishing a complete characterisation profile…(ICH Q6B) • Intrinsic part of assessing critical quality attributes (CQA, ICH Q8) - mechanism of action. “important property is the biological activity describes the capacity of a product to achieve a defined biological effect …” (ICH Q6B) • Measures the actual biological activity of the molecule “Potency is the quantitative measure of biological activity of the product…calibrated against a reference standard…” (ICH Q6B)

The Organisation for Professionals in Regulatory Affairs

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