eBook: Developing Assays — Considerations Across the Analytical Spectrum

Potency. Stability. Product characterization. Bioassays and other analytical methods provide a foundation of information on which biopharmaceutical development and manufacturing are built. Companies working with proteins, gene therapies, and other biological modalities are increasingly interested in taking a platform approach. They would love to have a set of go-to methods and protocols that can be applied across similar products in their portfolios. But adaptation inevitably requires and technical adjustment and risk management. Authors in this eBook provide perspectives on method development for safety and characterization, potency bioassays, process validation, and protein concentration measurements.

First, BPI’s editor in chief discusses the platform approach to gene-therapy analysis with SK pharmteco’s global head of analytical services, highlighting the power of next-generation sequencing and safety concerns with adenoassociated virus (AAV) products. Next KBI Biopharma’s senior director of analytical development and BPI's managing editor explore strategies for managing bioassay development and transfer to contract partners. Then authors from AGC Biologics highlight the need for at-scale physicochemical stability studies during process validation. And finally, two consultants with Syner-G BioPharma Group use a case study to demonstrate the importance of determining an accurate extinction coefficient for UV spectroscopic measurements of protein concentration in process solutions.

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