Quality Expert Urges Firms To Adopt QbD Approach When Developing Cell Therapies
Expert explains how firms can leverage pharmaceutical quality-by-design principles when developing cell therapies to help make sure their manufacturing processes remain in a state of control over the product lifecycle.
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Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.
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