Integrated control strategy development for a viral vector manufacturing process
A systematic, risk-based framework for integrated control strategy development in viral vector manufacturing — from defining the Quality Target Product Profile and Critical Quality Attributes to identifying Critical Process Parameters through FMEA and Process Design studies — ties product safety and efficacy directly to manufacturing controls, as outlined by Dr Amos Tsai of Samsung Biologics. The approach ensures a planned set of controls linking CQAs with process parameters and material attributes, with in-process checks deployed throughout to maintain consistency. This structured methodology is designed to enable seamless commercialization of advanced therapies.
A systematic, risk-based framework for integrated control strategy development in viral vector manufacturing — from defining the Quality Target Product Profile and Critical Quality Attributes to identifying Critical Process Parameters through FMEA and Process Design studies — ties product safety and efficacy directly to manufacturing controls, as outlined by Dr Amos Tsai of Samsung Biologics. The approach ensures a planned set of controls linking CQAs with process parameters and material attributes, with in-process checks deployed throughout to maintain consistency. This structured methodology is designed to enable seamless commercialization of advanced therapies.
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