Tech transfer to cGMP manufacturing is tricky business. Medicine maker Eva sure knows that it is crucial to record all steps and keep an open communication with suppliers. Unfortunately, Gene has some more learning to do.
It must have been one hungry dog Gene’s got. Especially considering the amount of records he should have kept during the technology transfer project! Hopefully Gene did stick to Eva’s good communication practices and managed to pull together the hard copies in the end.
If only we thought more about the tech transfer into cGMP manufacturing when developing a process at small scale. Results don’t automatically reproduce at large scale; several factors can influence the outcome.
One way to smooth the tech transfer process is to use the same equipment from pilot to production scale. For example, a bench-top chromatography system with a wide flow and pressure range can help. In this case, the same system can suit production of material for both technical batches, scale-up studies, and small-scale GMP batches.
There’s plenty to consider in tech transfer. But there are also great resources available. Why not attend a training course to learn tips and tricks for bioprocess scale-up and tech transfer?