Cell and gene therapies have a potential, unlike anything we’ve ever seen before in medicine. With the power to deliver curative relief...
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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...
Read moreThe Bustling Cell and Gene Therapy CMO Scene
Pharma’s new and exciting era of targeted therapeutics has the potential to be a turning point for modern medicine. The buzz has led to a...
Read moreThe 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...
Read moreHow 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...
Read moreViral 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...
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