Martin Victor, Design Transfer; Assay Production Penzberg
Diagnostics Operations Mannheim, in short DOM, ensures the global supply of patients, laboratories and hospitals with diagnostic reagents and test stripes. To this DOM as the largest field of Global Diagnostics Operations at the locations Mannheim and Penzberg produces a large variety of products for the in-vitro-diagnostics. With this program we want to show you some people which stand behind our success with proud and motivation.
In which area of DOM do you work?
“I work in the Design Transfer department. Our daily business is to provide assistance in production for product launches in Immunodiagnostics. We are responsible for the transfer of the assay design – which was developed in the Research and Development department – into routine production. In so doing, we prepare and carry out the appropriate process validation in order to ensure that production can also be carried out later on a routine basis with the required level of quality in a reproducible manner. Our team gets involved relatively early, normally even before the Design Goal milestone during the project kick-off. For example, in the launch of a second product generation, I was responsible for coordinating the activities of Penzberg Operations. It was all about ensuring that the reagents are made available on-time and according to the requirements.”
What were the factors that contributed to the success of the launch of the second generation and the roughly 100 assays?
“It was important that literally everyone in DOM was aware of what this was all about and what we needed to achieve with this project! There was a very tight timeline. Everyone involved had to give it their all in order for us to stay on track. Unforeseen things came up, of course, but the staff members involved jumped in and brought them under control. Entirely new processes were required for the project in some cases. We planned them and prepared for them way in advance.”
What were the greatest challenges? And how were they solved?
“We had a very tight timeline, which was assigned to us from the outside. There was very little wiggle room in the event that something would go wrong. It was also absolutely necessary that we plan for the additional capacity required in a reasonable and realistic manner. The program could not have been carried out without this. After all, the routine work had to be carried out as usual, in parallel. In retrospect, this planning proved to be correct.”
Have there been successful situations that you like to reflect on?
“Providing the calibrator sets required an enormous effort, which we initially underestimated. Even though we produced special quantities, we did not have to postpone any other production activities for product launches. That itself was a great accomplishment.”
What happens now in your work area, after such a large project?
“We are returning to the routine business – which has been expanded, of course, due to our experiences with the second generation platform – and we are handling new product launches as well as routine work. But: the next big special projects will come.”