As resources become less accessible – both in terms of funding and personnel - smaller or emerging sponsors are unlikely to have a large Chemistry, Manufacturing and Controls (CMC) group. In fact, in ...
BOSTON, Sept. 30, 2020 /PRNewswire/ -- Matrivax Research and Development Corporation has named Enda Moran, PhD, MBA, as vice president of process development and CMC. Dr. Moran will lead process ...
In this article, Senior Drug Substance Consultant James Mencel from DS InPharmatics offers information on his experience with CMC management and how the pharmaceutical industry has been impacted by ...
SEATTLE and COPENHAGEN, Denmark, Sept. 10, 2012 /PRNewswire/ -- CMC Biologics, a leading contract manufacturing organization known for its technical excellence in process development and cGMP ...
The Masterclass is intended to help you dive deep into the design and execution of the major CMC analytical studies. This will be opened by an overview of maintaining regulatory compliance for ...
Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively demonstrate safety ...
ProBioGen and Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine ...
This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...
Twelve gene therapies have been approved by the FDA to date to treat a variety of diseases, including the first ever gene edited therapeutic. The CMC package required to effectively demonstrate safety ...
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