Proteins—especially antibodies—are gaining in popularity in the pharmaceutical industry, both as drugs in their own right and as targeting...
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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.
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, but it was a fairly basic overview of the combination drug product regulatory landscape at a...
The High Bar for Gene Therapy CMC
WHITE PAPER The High Bar for Gene Therapy CMCHow drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After well publicized stumbling blocks in the late-90s, vigor was restored to the gene therapy field in...
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