Tracy TreDenick-Fricke Founding Partner, Head of Regulatory and Quality Working with my co-founders, colleagues, and clients on many...
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CMC Strategy
A Guide to Integrating QbD in Gene Therapy CMC Programs
Cell and gene therapies have a potential, unlike anything we’ve ever seen before in medicine. With the power to deliver curative relief to patients suffering from...
The High Bar for Gene Therapy CMC
WHITE PAPER The High Bar for Gene Therapy CMC How drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After...
