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Production site transfer: successful approaches to overcoming technical, regulatory and compliance challenges. 22-23
1The Business/Technology Interface Inc, 21 Tenby Chase, Voorhees, NJ, USA. rswoodward@net-gate.com
Abstract:
The conference brought together a number of process professionals, who discussed their insights on the challenges presented in transferring a process from one production site to another. It was emphasized that this transfer could occur either within a company (ie, pilot plant to full-scale manufacturing) or between companies (ie, to a contract manufacturer). The transfer process requires not only the transfer of production, but also the transfer of analytical methods. While the primary focus of the presenters was on biologics transfer, the subject matter was equally applicable to chemical processes.
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