Combination drug products (i.e., products that are a combination of a medical device and/or a drug and/or a biologic) are inherently complex to...
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BREAKING: Dark Horse Consulting Group acquires BioTechLogic, Inc.
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic, practical, and hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
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 therapeutics for prevalent indications. An interesting dynamic of the gene therapy market is that...
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 debilitating conditions — many of which have no treatment options — the cell and gene therapy field is...
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