The design and analysis of potency assays for biotechnology products

How do we measure the potency in a given bioassay?
Potency bioassays are used to measure biological activity.
Consequently, potency is considered a critical quality attribute in manufacturing.
Relative potency is measured by comparing the concentration-response curves of a manufactured test batch with that of a reference standard..
What are the methods of potency assay?
Potency assays can be one of two types: ligand-binding (measure interaction of drug with its target) or functional assays (measure a biological response).
ELISA or flow cytometry assay formats are often used to measure ligand-binding..
Why are potency assays important?
Potency measurements are a necessary part of product characterization testing, comparability studies, and stability protocols, which are used to establish that a consistently manufactured product is administered during all phases of clinical investigation..
Potency testing involves comparison of a product's biological activity to that of a reference preparation and cell-based potency assays are central tools used to measure drug efficacy during potency testing.
They allow scientists to see how a particular dose of a drug will react in a given biological system.

What is a potency indicating assay?

A potency or potency-indicating assay is a regulatory requirement for the release of every lot of a vaccine

Potency is a critical quality attribute that is also monitored as a stability indicator of a vaccine product

A robust potency assay requires precise and accurate procedures

This also applies to nonbiological analytical assays such as an enzyme-linked immunosorbent assay (ELISA)

More important (because of the inherent, nonrobust nature of biopotency assays) is the use of well-defined and accurate procedures

Biologics undergo extensive characterization to demonstrate their safety, purity, and efficacy

Jennifer Lawson (product manager for cell line, media, and testing solutions at Sartorius) highlighted the role of potency assays in that process