What are potency bioassays?
The quantitative measurement of potency plays a critical role in biopharmaceutical development. Potency bioassays are essential tools for the measurement of potency. However, the complexity of measuring a meaningful biological response representative of the biotherapeutics' mechanism of action can pose significant challenges.
Along with Tanvex Biopharma, we have applied a novel approach using the real-time kinetic capabilities of xCELLigence. This de-risks assay development for an inhibition of proliferation assay for an anti-HER2 monoclonal antibody.
Read more in our poster ‘Real-time kinetic data in the successful development of an inhibition of proliferation potency bioassay'.
Producing an anti-proliferation potency bioassay
Bioassay development followed these steps:
- Inhibition of proliferation assay principle and the potential risks for assay performance
- Application of real-time kinetic proliferation data in development
- Transfer of assay parameters to a CMC-friendly assay format
- Inhibition of proliferation assay qualification
We have successfully demonstrated the applicability of real-time kinetic data in the development of an anti-proliferation potency bioassay. The assay demonstrates reliable performance over time and is unaffected by different SK-BR-3 passage numbers, different operators, or different FBS lots.
It provides a detailed understanding of the effects of assay conditions on cellular responses, to produce a reliable bioassay with consistent performance. This is important for the development of proliferation bioassays for process development, characterisation, stability, and biosimilar similarity assessments.
Have any questions about our inhibition of proliferation potency bioassay?
Related articles
Successful approval of biological medicinal products in the EU and US requires characterisation of the biological product’s properties to enable the setting of specifications that control the molecule’s critical quality attributes (CQA) for release into the clinic and onto the market. Release specifications ensure manufacturing lot-to-lot consistency, product stability, and ultimately, patient safety. So, what are the main development considerations? We delve into these to future-proof your potency assays.
Explore our research poster as we analyse the data from our new cell line development platform, IndEx-2.
Development of a NK cell expansion protocol for use in assessments of NK-targeting therapeutics.