Module 9 2024

03/09/2024

What are Bioassays Used For?

Variety of purposes:

• Screening for active compounds (Early Development) • Pre-clinical efficacy – does it elicit the intended effect (Early development/Pre-clinical) • Immunogenicity – desired and unwanted effects (Clinical) • Potency assessment – Batch release testing (Pre-clinical/Clinical/Commercial) • Routine batch release testing (Phase III/Commercial) • Stability indicating (Phase III/Commercial)

*Bioassays are required at every stage of the drug development pathway.

The Organisation for Professionals in Regulatory Affairs

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Why are Bioassays Needed?

• Intrinsic part of assessing critical quality attributes (CQA) and intended mechanism of action.

“important property is the biological activity describes the capacity of a product to achieve a defined biological effect …” (ICH Q6B) • 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) • 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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