The Critical Steps for Protein Therapeutic Potency Assay Development

This webcast features: Jennifer Lawson, PhD, Global Product Manager, Cell Banking and Testing, Sartorius

Potency assays are an important part of the drug development process and are required throughout the lifetime of the product. The potency assay needs to correlate with the mechanism of action and provide an indication of stability. With these requirements comes a myriad of challenges in the development process, especially as therapeutics become increasingly complex. Assay development should be stepwise, starting with proof of concept and then optimization using design of experiment (DOE) to identify the best parameters quickly. Once developed, a new challenge presents in the form of assay qualification and validation to good manufacturing practice (GMP). To avoid these challenges at later stages when a delay is costly, it’s crucial that the development starts early in the drug development process. The lifecycle of potency assay development ideally should be stepwise across the lifetime of the therapeutic development. Sartorius has developed their Chinese hamster ovary (CHO) platform for protein expression with this in mind and has designed the CHO platform to include assay development services right from the start. This webinar will discuss the process of assay development, qualification, and validation for critical potency assays and how Sartorius supports customers through this vital step.

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