Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow...
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Gene Therapies
Strengthening Your Gene Therapy Process Control Strategy
WEBINAR ON-DEMAND Strengthening Your Gene Therapy Process Control Strategy Given the incredible diversity of gene therapy product characteristics, there is no “one solution...
Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle
eBook Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle This guide gives gene therapy innovators a high-level perspective on the process development...
AAV Viral Vector Production at Scale—Improving the Current State
The gene therapy sector is continuing to come into its own, and many developers are shifting their attention from nearly exclusively treating rare diseases to developing...
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...
