Module 9 2024

03/09/2024

What are Bioassays?

Bioassays assess a therapeutic’s biological properties; they describe the specific ability or capacity of a product to achieve a defined biological effect. ICH Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products • Provides high level guidance for the variety of tests/criteria needed for biological products. Examples of procedures to measure biological activity include: • In vivo – measures an organism’s biological response to a product e.g. in a mouse or human • In vitro – cell culture-based biological assays which measure biochemical or physiological responses at the cellular level e.g. cell activation or death • Biochemical assays – measure biological activities e.g. enzymatic reaction rates, immunological interactions, also receptor/ligand binding assays.

The Organisation for Professionals in Regulatory Affairs

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Bioassays

Very valuable resources:

USP Chapters

1030 (Overview & Glossary)

1032 (Design & Development of Biological Assays)

=

suite of USP bioassay chapters

1034 (Analysis of Biological Assays)

focus = relative potency assays.

1033 (Biological Assay Validation)

The Organisation for Professionals in Regulatory Affairs

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