A cell culture perfusion-based clinical production process was developed and scaled-up under an unusually compressed timeline to enable production of a human enzyme. A parameter risk assessment and gap analysis were first performed to guide the development strategy. Operating parameters were classified as high, medium, and low risk, based on process knowledge and similar in-house processes. High risk parameters, including pH, temperature, and perfusion rate, were concurrently optimized and characterized to establish acceptable operating ranges in support of GMP manufacturing. Acceptable operating ranges for low and medium risk parameters were assigned by leveraging process knowledge from other similar Shire projects. Process performance at bench and large scale, including cell growth, metabolite profiles, product yield and product quality is discussed.

Rapid development and scale-up of a controlled cell density perfusion process for a human enzyme

245th National Meeting (2013)

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