Dave Adams is a Senior Drug Substance Consultant at Design Space InPharmatics. Today, Dave joins the show to share his experience solving problems in active pharmaceutical ingredients (APIs). In this episode, Ed, Brian, Meranda and Dave discuss the importance of comprehensive development programs. Dave speaks to quality assurance, tech transfer procedures and real-world case studies that he has encountered throughout his career.
“Manufacturing of APIs was very much a technical job, not a scientific process.”
“In production, time is money. The longer it takes to run the process, the more it’s going to cost your company or the more that a CMO is going to charge you to manufacture your product.”
“You need to very carefully scout your suppliers and make good agreements with what it is they’re going to be supplying to you.”
“So yes, you need to investigate every ramification of development. And some of them might lead to surprises – you see in new impurities or new emulsion – and so you’re going to have more development.”
“It helps to have somebody on your side who understands production and knows when you’re being taken advantage of and even upfront when you’re making your contracts.”
“It is very important to have one process owner – process champion – one person who represents the process.”
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