Interview: Birgit Pittermann - Research & Process development
Research expertise for the pharmaceutical and biotech industry
Birgit Pittermann, Corporate Head of Research & Development, provides insights into product and process development at our TechCenter ZETA in Lebring.
What are the challenges in pharmaceutical process development? Which process steps are particularly relevant? Which studies are used for the further development of processes and products and which research priorities are set for this? These questions and a very personal look at the TechCenter are answered in the following interview.
Research and development is driven forward
Pharmaceutical process development and optimization repeatedly give rise to special questions and technical challenges. How can these be answered and what approach has ZETA chosen in this regard?
Since this usually involves complex issues, these can best be tackled in cooperation with the customers. In close cooperation and exchange with the companies and renowned research partners, we have already tested and developed an enormous range of specific technical solutions.
Not least, the downscaling of production plants to laboratory or pilot scale enables a wide variety of test series. Furthermore, experimental approaches are combined with simulations.
In order to protect the company's own know-how, patents are regularly registered for processes and products developed in the TechCenter. How many have you filed in the course of time, and what are the first steps in product or process development?
We have already registered several patents in different areas - and constantly there are more being added. Process development often goes hand in hand with the development of components that offer added value for (bio)pharmaceutical production.
Therefore, as a first step, it is particularly important to develop prototypes for components such as cleanroom wall passages for single-use tubing or stirrer blade combinations. This is precisely what we have focused on in our TechCenter.
In connection with the TechCenter, the term "CFD studies" is mentioned time and again. Can you explain the term in more detail and state the major advantage of this?
A computational fluid dynamics simulation study is a computer-aided calculation of mass and heat transfer processes in a production plant. It is also a tool for the dual approach to development, combining experiment and simulation. This combination is becoming increasingly important in process and product development. The most important advantage of such a simulation technology is the possibility to gain deep insights into the process by analyzing data that are difficult or even impossible to measure.
For valid statements, the simulation models are verified by reliable experimental data.
Every single development task has its own particular challenges. For the customer, it is essential to quickly find a suitable solution for minor investigations or improvements. Depending on the problem, colleagues from different disciplines then work together on the individual issues.
A special research project in recent years was concerned with a UV-C reactor for virus inactivation. What exactly was it about?
We carried out this research project in cooperation with SES-Tec and a partner company from the plasma processing industry. In our TechCenter, the system was tested with regard to its process characteristics and applicability for a pharmaceutical production process, combining experimental procedures and CFD analyses.
The central question to be answered was how to uniformly expose a valuable and sensitive product solution to a defined UV radiation. As requested, the results were used by our customer to calculate the efficiency of the reactor and as a basis for further developments. This project is a prime example of how we successfully develop customer-specific solutions and solve special problems.
Which research project or product development are you particularly proud of?
Every single development task has its own particular challenges. For the customer, it is essential to quickly find a suitable solution for minor investigations or improvements. Depending on the problem, colleagues from different disciplines then work together on the individual issues. This makes development very complex.
If I think of our sterile connectors, for example - it is thanks to the ambition of all the employees who were involved that, after an intense period of research and development, we were able to bring an outstanding product to the market.
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