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Technical Transfer
Transferring knowledge and experience from one set of skilled personnel to another requires a systematic and careful approach.
The transfer of a process from one stage to the next, i.e. from research to development, from development to pilot plant or from pilot plant to production, can be the most challenging part of the process development. Since the technical transfer stage involves transfer of knowledge about the process and the product, careful documentation at all stages from research through development is essential for success.
Transfer should be supported by a detailed Technical Transfer Report also including failures and gaps in what has been achieved so far in order to make all remaining issues visible for the receiving department. It is the responsibility of research to provide documented evidence for a rational process design and also to provide the comprehensive process description necessary for successful transfer, including items such as:
Process parameters, ranges and tolerance limits
- Process volumes (as c.v.)
- Flow velocities
- Buffer specifications (pH, ionic strength)
- Sample specification (pre-treatment, filtration, buffer, target product concentration)
- Product and protein load/ml resin
- Volume load/ml resin
- Step elution set points or gradient formation
- Resin bed height
- Pressure drop
- Quality criteria for packed bed
- Fractionation scheme
- Cleaning and sanitization solutions
Product information
- Stability
- Sensitivity
- Off-line activity assay
Process control
- Sample specific detector
- Critical and non-critical instruments Alarms: Elution profile, fractionation pattern
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