Technology transfer in the pharmaceutical industry
It is first about the technology
Central to technology transfer in this case is always the transfer of the technology itself
Whether it is a technology transfer or a simpler production transfer.
In order to avoid delays in the registration or adaptation of the registration documents, the transfer should be designed in such a way that as few technological changes as possible are necessary. This means that the essential manufacturing process steps should be carried out with the same technology, lead to the same result and be "similar".
When transferring technology, you usually leave the specifications untouched. After all, you want to produce the product at the new location within the unchanged specifications.
The requirements of the "same technology" are usually relatively easy to transfer. In contrast, older products that are still running on the original equipment usually require a very large technological leap to switch to modern equipment.
Systematic experimental design
Contrary to this trial-and-error technique, we try to transfer the process steps in such a way that not the "parameter settings" are identical, but the process shows the same behaviour.
In concrete terms, we test - whenever possible - the influence of the most important parameters, first in small-scale tests in the laboratory. In this example, these would be the amount and speed of the liquid added, the viscosity of the liquid, the spray cone, the speed of the granulator, the speed of the chopper wheel, and the total amount of the mixture.
These experiments are not carried out individually (as so-called OFAT "one factor at a time" experiments), but as factor combinations. The parameters are changed together in blocks according to a certain scheme. Defining the right combinations in this step is, in our opinion, one of the most essential points to carry out the experiments quickly and efficiently.
For the above-mentioned parameters, for example, an "eight trials programme" would be suitable. The costs of such a laboratory trial are only a fraction of an industrial production. However, the data situation after the execution in the laboratory is much better than after even only one technical batch.
After the laboratory test and evaluation, one can already make a first working estimate for the correct settings of the production plant. This provides much better starting conditions for possibly only having to produce a technical batch or, if you have very solid data, to go straight into validation. This procedure also provides the right basis for optimisation (faster production/higher quality).
It is highly likely that the tests will show that the old settings cannot simply be adopted for the new system. The new granulator is larger and runs at higher linear speeds with the same speed setting (of the rotation), i.e. it applies higher shear forces with the same rotation. Accordingly, the size distribution of the granulates produced will shift. To ensure similar conditions as in the existing production, the new granulator must therefore run slower (rotate more slowly) than the one in the old plant. Only then will you get the similar or identical shear forces as in the existing process.
With our approach, we then check process step by process step and propose the necessary adaptations for GMP production. We concentrate on a minimum of laboratory tests and thus save the budget for the validation runs in production.
In summary, this means for technology transfer:
We model both processes (old/new) with the help of some laboratory tests. This gives us valid insights into the technology of the process step itself and we can then easily adapt it to new equipment. Technical trials in production with full batch size are thus reduced to what is absolutely necessary, costs are lowered and transfer time is significantly reduced.
If you have any further questions about technology transfer, please do not hesitate to contact us. Please feel free to contact us!