We at the cleanroom trade fair
Lounges in Karlsruhe

We designed a panel discussion

A successful as well as novel event was mastered by the ISPE Student Chapter Karlsruhe within the Lounges.

On the subject:

“Challenges for plants and people in the focus of Industry 4.0”.

Ms. Pia Graf (M. Sc. Chemical Engineering) and Ms. Patrizia Gartner (Board Member ISPE SC KA and M. Sc. Bioengineering) introduced the topic in relation to the red-hot field of cell and gene therapy during a panel discussion and discussed it with participants from the industry.

As guests we had the pleasure to welcome Dr. Michael Atzor (former Project Management and Engineering for Pharmaceuticals and Biopharmaceuticals at Bayer) as well as Mr. Dirk Steil (Managing Director of Becker Reinraumtechnik). Challenges, goals and future potentials of cell and gene therapy as well as clean room technology were controversially explained with both experts.

The four classic goals of production in the age of Industry 4.0 were addressed:
Reduce costs, reduce time, ensure quality and enable production flexibility.

Emphasis was placed on the importance of reducing costs in order to make cell and gene therapies available to the broader community. For this purpose, an overarching cooperation of all companies is absolutely necessary. Competitive thinking must be put in the background here and the overriding purpose of serving the good of society must be focused on, according to Dr. Atzor. Technically, a superordinate network could be realized by means of a sharing data platform and cross-company concepts.

Another challenge is to accelerate the development of individual allogeneic cell therapies. Enablers are modular equipment, the use of I4.0 tools, including training and assistance systems to support operators, digital twins for plant and process planning, and BIM (= Building Information Modeling) for integrated factory planning incl. Interfaces with suppliers and customers. The latter is especially crucial in cleanroom planning, according to expert Dirk Steil. The consistent introduction of PAT (= Process Analytical Technology) is also a prerequisite for rapid development. In addition, companies must work closely with the FDA and regulatory agencies to validate processes early and ensure quality. For humans, the new technologies pose a variety of challenges: For example, qualified personnel are required who can also perform changing operator tasks. Internal staff training but also, and above all, an understanding of the benefits of the new technologies should be promoted through workshops.

The event was very well attended with about 30 people, the feedback was positive throughout.

The ISPE was also represented with an information booth over the three days at the lounges and took the opportunity to expand its membership circles.
We would like to thank the ISPE YPs for the great opportunity and Dr. Atzor and Mr. Steil for their exciting contributions.

Your Patrizia Gartner
(Board of Directors ISPE SC KA)