by Trefor Jones` | Sep 11, 2024 | Uncategorised
We probably all understand what scaling-up a process is – increasing the batch size to reap the economies of scale and also many of the problems that have been encountered along the way. But scaling down? Why? The reasons for scaling-down a process are not always...
by Trefor Jones` | Jul 1, 2024 | Uncategorised
Risk assessments are an essential part of technology transfer, but it is surprising just how often they are misused – usually by being used to justify what is already being done rather than looking to see how process risks can be eliminated, or at best mitigated....
by Trefor Jones` | Jun 3, 2024 | Uncategorised
I’m sometimes asked if a transferred process should use the same Critical Performance Parameters (CPP), Proven Acceptable Range (PAR) and Normal Operating Range (NOR) parameters and values and what parameter values should be used in the manufacturing documentation for...
by Trefor Jones` | May 8, 2024 | Uncategorised
Blog 12 – Technology Transfer of Clinical trial manufacturing. Firstly, what is Technology Transfer – I suppose putting simply it, includes everything that’s needed to move a technical process from one location to another. See my Blog #1 for more detailed...
by Trefor Jones` | Oct 12, 2023 | Uncategorised
The question of how many batches have to be run is a recuring question, not always easy to answer and there is a great temptation to just say three (3)! Although industry has typically used three batches during the process performance qualification (PPQ) phase to...
