Five-Point Checklist for Pharmaceutical Scale-Up

Posted by David Watt and Norm Fong

Scale-Up Blog Series, Part 3

[Editor’s note: Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. This is part 3 of an in-depth, multi-part series on product scale-up. Visit our blog page to read parts 1 and 2.]

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Topics: scale-up, SUPAC, Process Development, CMO Partner, excipients, Registration Batch

Part 6 — In-Licensing Pharmaceutical Products: Due Diligence Can Help You Perform a Technology Transfer Successfully

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 6 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: due diligence, USP standard, API, excipients, development reports, complaint history, in-licensing