Article | May 8, 2023

Build A Foundation For Successful Clinical Manufacturing By Drafting And Sharing Product Definitions Early

Source: BioCentriq
Pipette clean room laboratory cell and gene GettyImages-530817998

A much-discussed topic in the industry today is the need to implement a quality-by-design approach to process development work. Quality by design is a strategic, systematic approach to development and manufacturing, beginning with predefined objectives and focusing on both product and process understanding and control built upon sound science and quality risk management. Having at least a draft of both your quality target product profile (QTPP) and critical quality attributes (CQA) in place — and having a firm handle on how your process parameters and material attributes impact them — is a must.

While that is easier said than done, the work that needs to be completed before you move into clinical manufacturing, in terms of defining your product profile and corresponding specifications, can be achieved by beginning with an end goal in mind and understanding your process capability as much as possible. Learn how defining specifications, quality attributes, dosing strategies, critical process parameters, and more before moving into GMP manufacturing – even if you’re still working on IND enabling studies – is essential for your product’s success.

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