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Promega offers an extensive toolbox of reporter bioassays to characterize and develop novel monoclonal antibody (mAb) and cell-based therapeutics.

These assays are useful for interrogating a range of biological functions, including Fc effector activity, immune checkpoint modulation, T cell activation, and cytokine and growth factor signaling. 

We maintain a dynamic portfolio of quantitative, accurate and precise bioassays and can partner with drug developers in the early stages of biologic development to ensure that our bioassays meet your needs.

An Introduction to Bioassays

Bioassays are analytical methods for measuring the concentration or potency of a substance through its effects on a living system. This assessment is generally achieved through comparison of the response of a test substance with a that of a standard. 

These assays can utilize live organisms (in vivo) or tissues or cells (in vitro). Some common categories of bioassays include flow cytometry, proliferation, apoptosis and functional reporter bioassays.

Bioassays are essential for the development of pharmaceuticals as they can provide critical data on potency and stability of drug products. Bioassays are also frequently used to ensure quality of manufacturing processes and perform lot release testing. Furthermore, these assays are used in the establishment of dose-response relationships that determine safe and efficacious levels of drug products. In addition, bioassays can provide evidence to confirm biocomparability of innovator and biosimilar products. 

Ultimately, an effective bioassay is reliable, standardized and reflective of a drug’s mechanism of action.