9th Pharma Forum: International platform for knowledge transfer , innovation, and networking at OPTIMA pharma

Dr. Mostafa Nakach (Sanofi) addressed vial filling as a crucial aspect of the quality of freeze-dried products. Using concrete examples, he showed how even the smallest deviations in the filling process can influence the lyophilizate structure and what consequences this has for the stability and acceptance of batches. His insights made it clear that innovative methods and in-depth process knowledge are critical in this area.

Another international impetus came from Prof. Dr. Mazen Hassanain, founder and CEO of SaudiVax. He provided insights into the Kingdom of Saudi Arabia's Vision 2030 and explained how the country is promoting the development of a high-performance biotech and pharmaceutical industry. The focus is on the development and production of biopharmaceuticals and vaccines in the country itself, the promotion of local research, and international cooperation and collaboration – an example of how national strategies can influence the global pharmaceutical world.

Bart Francis from Pfizer offered a glimpse into the future. In his presentation, he reflected on the lessons learned from the COVID-19 pandemic and showed how these insights can be applied to the filling line of the future. His vision: a highly flexible, digitally networked line that is reliably operational even under extreme time pressure and sets new standards in terms of safety and efficiency.

Things got emotional when Bradley Watts from the Emily Whitehead Foundation took the stage. He talked about his personal journey as a patient who, after several rounds of chemotherapy, radiation, and other treatments, was treated with CAR-T cell therapy – and has been cancer-free ever since. His story gave the forum a human dimension that went way beyond technology and processes. Watts made it clear how important it is that as many people as possible worldwide have access to this form of therapy. Optima is contributing to this: Together with the Robert Bosch Hospital in Stuttgart and the University of Heidelberg, the company is developing ProCell, an automated production system specifically for CAR-T cell therapies.

 

Machine tour featuring innovative technologies

During the tour of Optima’s three CSPE centers, guests were able to see how integrated complete systems consisting of sterile filling lines, isolators, and freeze dryers are manufactured - and which solutions are used for filling syringes, vials, and cartridges. Other stations highlighted additional topics in the pharmaceutical industry: The development and use of enzyme indicators, the use of digital twins, and new forms of customer and employee training in the newly expanded training area. Visitors showed particular interest in the integration of artificial intelligence and digitalization into the production process.

Experts provided insights into alternative cooling agents, which are becoming increasingly important in terms of sustainability and regulatory developments. On display was the LYO-SCALE, a freeze dryer that can be used to develop recipe parameters for freeze drying processes on a small scale and scale them up to larger plants.

Annex 1 was also explored in depth throughout the tour. Participants gained insights into the practical implementation of regulatory requirements. The focus was on technical solutions including automated product path handling, Annex 1-compliant setup, the integration of real-time monitoring systems, PUPSIT filter tests, and optimized format part handling during setup. The presentations showed how targeted automation and well-planned designs ensure both process reliability and regulatory compliance.

“The Pharma Forum impressively demonstrated the dynamics of our industry,” emphasized Johannes-Thomas Grobe, CEO of Optima Pharma. “The topics discussed here are trend-setting – they show where development is heading and what answers we need to find together. The next Pharma Forum in 2028 will build on this and once again serve as a platform for exchange.”