by Trefor Jones` | Apr 1, 2025 | Uncategorised
I’m sometimes asked how, as a technology transfer consultancy we can perform a technology transfer of a product from one site to another much faster than the manufacturing companies themselves – for instance can complete a transfer in 6 months whereas the...
by Trefor Jones` | Apr 1, 2025 | Uncategorised
In transferring processes from one site to another or scaling up a process we often find that the process involves one or more stages that cannot be directly transferred due to either differences in equipment used or differences in scale. Mixing and lyophilisation are...
by Trefor Jones` | Nov 26, 2024 | Uncategorised
The technology transfer of pharmaceutical products often occurs between the USA and the EU & UK. While there are many similarities between the USA and the EU/UK GMP regulatory requirements, there are also differences which need to be understood and taken account...
by Trefor Jones` | Oct 2, 2024 | Uncategorised
PPQ batches are performed to demonstrate that the process under test can be manufactured consistently. You are expected to do this on a statistical basis. I’ve often wondered how you can demonstrate this with only (probably) three batches. It’s all very well...
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....
