Bringing a new drug to market is a complex process that can take years with no guarantee of a successful outcome. The journey is highly regulated and includes numerous processes that require drug developers to have multiple levels of expertise within their teams. One...
The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must...
By: Mayuri Mutha, Senior Manager, CMC Development & Project Management Joseph Sclafani PhD, Director, CMC Development & Project Management Drug development is a complex, expensive, and multistage process which could take 10 to 15 years to bring a new molecule...
Developing biologics can be challenging. Their development protocols are significantly different from small molecule drugs, which provide a general response and comprise as much as 90% of the pharmaceutical drug market. Biologics are more complex, though, with...
Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop...
By: Deb Quick, Ph.D. Senior Consultant Everyone knows that good aseptic technique is crucial when handling biological products, particularly in fill and finish operations. But for cellular therapies, good aseptic technique is essential throughout the entire process to...
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