ATMP Seminar Hosted by the Aseptic Processing Community of Practice at Miltenyi Biotec
A Look Back at Two Days of Professional Exchange on Trends, Opportunities, and Challenges in the Manufacturing and Commercialization of ATMPs
On 25. and On June 26, the CoP Aseptic ATMP seminar took place at Miltenyi Biotec in Bergisch Gladbach. About 30 participants used the event as an opportunity for an open and practical discussion of current developments in ATMP manufacturing.
Scale-up, Scale-out, and Commercialization
The focus was on case studies of scale-up and scale-out concepts, issues related to commercialization, and the reimbursement of ATMPs in Germany. The presentations demonstrated how important it is to consider technical, regulatory, and health economic requirements together from the outset.
Regulatory Developments and the Risk-Based Approach
Other key topics included the interfaces between EU Part IV and Annex 1, the expected revision of EU Part IV, and the upcoming SOHO Regulation with its potential implications for autologous and allogeneic ATMPs. There was a particular focus on how the risk-based approach can be aligned with the requirements of quality risk management.
Technological Innovations and Practical Insights
Technological innovations rounded out the program: Presentations covered new approaches to the use of isolators, solutions for introducing sensitive materials, optimized H₂O₂ decontamination processes, and FR-Jet Technology for the production of LNPs.
A particular highlight was the tour of Miltenyi Biotec, which provided an impressive glimpse into the technical capabilities of the facility.
We would like to extend our heartfelt thanks to Miltenyi Biotec for their hospitality and support, to all participants for their active discussion, and to the ATMP Working Group within the CoP Aseptic for their dedicated organization.
