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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The EU Clinical Trials Regulation – Experiences from the First 18 Months
Originally posted on Regulatory Focus – a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial...
CMC Expertise Accelerating Biologics Development for 20 Years and Counting
Tracy TreDenick-Fricke Founding Partner, Head of Regulatory and QualityWorking with my co-founders, colleagues, and clients on many fascinating projects over the last twenty...
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...
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