The design of a GMP manufacturing process can be considered complete with the selection of raw materials, scheduling of process
steps, and design of process conditions, parameters, and equipment. Generation of GMP batch production protocols and records
can be started at this stage.
COMPLETION OF THE TRANSFER
Technology transfer starts with the transfer of the document package and ends with the successful engineering run. Technology
transfer ensures the success of GMP production, although the GMP manufacturing operation itself is not a part of technology
transfer. The success of GMP production can only be ensured upfront when the small-scale prototype runs and full-scale engineering
run consistently meet the expected product yield and quality (e.g., purity, efficacy and safety). In fact, the product yield
and quality after each process step should be comparable between sending and receiving sites. To evaluate the comparability,
an expected or acceptable result range for each relevant parameter should ideally be set upfront. The acceptable range can
be assigned based on the available data at the sending site on several runs of the process at the finalized conditions. Any
significant discrepancy in yield or quality must still fall within the limit for desired application of the drug substance,
whereas the technical reason behind the discrepancy must be well understood and under control.
Technology transfer of a biopharmaceutical manufacturing process can be very challenging, and any inefficiency in technology
transfer results in serious loss of time and resources. Although a transferred process should ideally remain the same as the
original, in practice the process always undergoes some adaptation at the receiving site, mostly due to the difference in
equipment between the sending and receiving sites as well as the need for scale-up of the entire process. The success of technology
transfer relies primarily on the adaptability of the production process itself as well as communication between sending and
receiving sites. A systematic transfer methodology provides the best chance of a successful technology transfer.
Tangir Ahamed, PhD*, is a scientist, Michel Brik Ternbach, PhD, is a scientist, and Paul Ives, PhD, is director of manufacturing, all at SynCo Bio Partners B.V., Amsterdam, The Netherlands, email@example.com
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2. A. Reinink, Entrepreneur, April 20, 2010.
3. D.C. Smith, BioPharm Int.
22 (4), 10s–17s (2009).
4. J.M. Liddell, BIOprocessing
1, 2–4, (2009).