Technology Transfer and Scale-Up

MacLennan Troll, E. Technology transfer and scale-up. In Preparing for FDA Preapproval Inspections, (M. D. Hynes, ed.), Marcel Dekker, New York, pp. 215-231, 1998. 

The pilot plant and its staff play a critical role in technology evaluation, scale-up, and transfer activities of new products. These activities begin early in the development cycle and include technical aspects of process development and scale-up, organization and responsibilities of technology-transfer teams, documentation of the transfer process, and often preparation for an FDA pre-approval inspection (PAI). A properly designed and operated pilot plant can enhance the collection of scientific data necessary to support internal transfer activities, as well as regulatory submissions and FDA PAIs.P ... 

An improved ability to address the key issues of technology transfer and manufacture scale-up. 

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