Tracy TreDenick-Fricke Founding Partner, Head of Regulatory and QualityWorking with my co-founders, colleagues, and clients on many fascinating...
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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...
Gene Therapy CMC & Manufacturing Approaches Are Maturing
The gene therapy sector is maturing and the industry is poised to be able to produce products in more consistent and scalable ways. Although the COVID-19 pandemic caused...
Gene Therapy CMC Strategies Paving the Way for Commercialization
By Tracy TreDenick-Fricke, BioTechLogic, Head of Regulatory and Quality, and Senior Consultant Since their discovery, gene therapies have been praised for their ability to...
