Development of an inhibition of proliferation potency bioassay

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.