Potency Assay Development – Turning an R&D Assay into a GMP QC Assay

Potency is an important critical quality attribute of any large molecule drug product and a precise and accurate assay is required for the release of drug product under Good Manufacturing Practice (GMP). Potency assays are technically difficult to develop and transfer but are also an essential part of the analytical strategy in any drug development pathway.

The potency assay is used to measure the ability of a drug to elicit a particular response at a certain dose in a relevant biological system and should ideally reflect the known mechanism of action of the drug and that it is related to the expected clinical response.

Developing a suitable potency assay is fraught with challenges and so a well thought-out plan and an understanding of what is important at each stage can help enormously.

In this webinar, the presenter will focus on the cell-based potency assay, the principles of which also apply to ligand-binding assays (ELISA).

Specifically, the webinar will cover:

• An introduction to relative potency assays including regulatory requirements, why a dose range is used and how to assess similarity to a reference standard.
• Specific considerations for development and optimisation of the assay for GMP environment. Including
  • Choice of plate layout and cell culture format
  • Optimising assay parameters such as incubation times, temperature and cell passage number
  • Analysis of the data produced by your developed assay
  • Differentiating and understanding the differences between system suitability criteria and sample criteria
• Strategies used to evaluate the performance of the potency assay prior to the validation phase including useful tips on monitoring the performance of the assay and what to track once the assay is developed

Speaker

Emma Bowen, PhD, Senior Assay Development Scientist, Covance

Dr. Emma Bowen is an assay development scientist who, for five years at Covance, has experience with developing and optimising cell-based potency assays for a range of large molecules. From monoclonal antibodies, to hormones, to cell and gene therapy molecules, Dr. Bowen has developed and validated many assays into fully GMP-compliant QC methods. With a background in high-throughput assay optimisation from a PhD in RNAi screening at the University of Sheffield and experience of GMP study management, she has helped many clients take the steps required to have an informative potency method.

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