The gene therapy sector is continuing to come into its own, and many developers are shifting their attention from nearly exclusively treating...
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Resources
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...
Combination Drug Products– Regulatory Landscape Update
In 2016 we released a paper, “4 Things You Need to Know About Combination Drug Compliance.” This paper is still entirely relevant today, and we encourage you to download it,...
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...
How the Industry’s Pandemic Response Opened the Door to Therapeutic Opportunities
The biopharma industry was certainly not immune to the turbulence brought about by the COVID-19 pandemic. The pandemic disrupted — and in some cases, stopped completely —...
Viral Clearance Studies for Gene Therapies—Easier Said Than Done
While incidents of biotherapeutic viral contamination have occurred, due to well-established knowledge of the potential sources of contamination and procedures to prevent...
