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Scale-up/transfer
Design the laboratory-scale experiments as a scaled down production process. Document to help subsequent scale up and consider system design and handling at large scale.
Successful transfer of a chromatographic purification process from the development phase at small scale to final production scale requires solid and extensive collection of relevant information and proper documentation of R&D results. System design should be considered as well as handling aspects at large scale.
A smooth scale up procedure based on a well prepared technical transfer will assure product quality, overall economy and timely achievement of market readyness. Proper consideration of scalability as early as possible during development will make technical transfer straightforward.
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