Articles
Technical Transfer Of Manufacturing Processes From Client Sites To A CMO
October 9, 2009
•Feature Article: Technical Transfer Of Manufacturing Processes From Client Sites To A CMO
By Nigel Shipston
Legislation for the European Community (1) requires drug products used in clinical trials to be manufactured in CGMP facilities that have been inspected by the appropriate regulators. In Europe, such drug products are called investigatory medicinal products (IMPs). ICH Topic Q7A covers the manufacturing of bulk active pharmaceutical ingredients (APIs). Section 19 of that guideline specifically covers the manufacture of APIs used in clinical trials (2). So there is an increasing need for the services of contract manufacturing organizations (CMOs) that can provide CGMP facilities combined with the specialist development and manufacturing expertise required to undertake biopharmaceutical production and preparation of appropriate documentation.
Small drug discovery companies and virtual organizations that license in promising, novel biopharmaceutical products frequently seek CMO partners. Typically they either will have developed or have access to laboratory-scale protocols for preparing a few hundred milligrams of their lead product. That may be sufficient to demonstrate efficacy in early stage preclinical studies. But the companies often lack the necessary combination of experience, time, and capital resources required to manufacture sufficient quantities of their product in compliance with CGMP standards — making that product suitable for use in clinical trials as part of a submission to regulatory authorities.
In addition, some companies that already have CGMP capability may seek to access additional manufacturing capacity through a CMO without having to commit to further capital expenditure. Either way, transfer of a laboratory-scale procedure for manufacturing a recombinant protein product from a client site for development of a scaled-up, GMPcompliant manufacturing process is a complex undertaking that presents a multitude of challenges.
Reprinted with permission from BioProcess International. (September 2006)
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