Technology transfer is, in large part, transfer of process knowledge from the development group to a manufacturing site. Because process simulation models represent a succinct, functional repository of process knowledge, they are a natural addition to the technology transfer process. This paper focuses on the capabilities and limitations of simulation models for technology transfer. Process-Facility fit is part of the technology-transfer process and is ultimately a determination of whether and how well a given process can be executed in a particular facility. Gap analysis is often the technique of choice for evaluating a facility. This presentation primarily focuses on the use of process simulation and scheduling tools to add quantitative information to gap analysis. A series of examples demonstrate how simulation can aid in determining gaps in primary equipment, buffer preparation equipment, purified water, utilities, labor and staffing. Techniques for managing uncertainties in process facility fit will also be covered.

Using simulation for bioprocess technology transfer and process-facility fit

243rd National Meeting (2012)

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