Regulatory Aspects of Gene Therapy and Cell Therapy Products by Maria Cristina Galli & Mercedes Serabian

Author:Maria Cristina Galli & Mercedes Serabian
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

3.1.2 Manufacturing Process

A well-controlled manufacturing process is one that reproducibly yields a product of desired quality, i.e. target profile. That profile needs to be defined as clearly as possible for the given stage of product development. The process parameters and in-process controls should be derived from studies investigating the critical quality parameters of the product. Scientific knowledge from research and development can be of value to justify the expected link between the manufacturing process and the quality parameters selected to control the manufacturing process. Hence, closely linked with the definition of the target profile is the definition of critical process parameters, i.e. which process steps and operating conditions are essential to obtain the desired product quality and what are the operating conditions required to achieve that goal. A risk-based approach [4] could be considered (and brought to this deeper level) to scrutinise the critical process steps and identify the optimum conditions for those steps that will ensure generation of a consistent product for marketing authorisation.

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