Quality Advice On How To Surf The Approaching Wave of Cell And Gene Therapies
Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.
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Authorities from the international Pharmaceutical Inspection Co-operation Scheme have suggested splitting the existing Annex 2 of the PIC/S good manufacturing practice guide in a bid to resolve divergences with the EU ATMP manufacturing guide.
New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.
The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.