Part 2 — The Ins & Outs of Technology Transfer

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 2 of an in-depth, multi-part series on tech transfer. Visit our blog page to view Part 1.]

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Topics: CMO, technology transfer, process design, GMP, quality controls, scale-up

Part 1 — What is a Technology Transfer and How to Ensure a Successful Transfer

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

Current market conditions, as well as a myriad other factors, have increasingly prompted drug developers to establish complex supply chains to ensure the commercial-scale manufacture of the compounds they’ve created. Perhaps one of the most important links in any contemporary supply chain is the one between drug owners and the contract manufacturing organizations (CMOs) they partner with to ensure that supply will meet the demand for their therapies. When it comes to these relationships, success hinges on several critical factors, but chief among them involves getting a highly critical process right: the technology transfer.

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Topics: technology transfer

Principles of Technology Transfer

Posted by Norm Fong

In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.

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Topics: Manufacturing Scale-Up, technology transfer, site-to-site, site-to-CMO, site transfer