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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The T-cell therapy company has been tipped as a potential leader in a potentially disruptive field as new data support wide application in cancer.
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.
Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.