“The Product is the Process – Is it?” Manufacturing and Translation of ATMP and Tissue-& Cell-based products
Several products have meanwhile achieved marketing approval and some ATMPs even reached broad clinical application. In addition, another multitude of product approaches are in the early development phase or in clinical trials. Concomitantly, a complex and dynamic regulatory environment has emerged in this modern biotechnological area.
To facilitate that ideas and development approaches can be translated to safe and effective medicines for patients, the intensive exchange of expertise between involved stakeholders in research, clinical, industrial as well as regulatory affairs is required. This also includes aspects of manufacturing and testing as essential part. Thus, discussing regulatory requirements together with entrepreneurial aspects, medical needs and possible technical solutions is an important way of making information and expectations transparent and counteracting erroneous trends. This symposium offers a forum for information and intensive exchange of current developments, experiences and requirements including authority representatives.
The symposium is organized in collaboration with the Paul-Ehrlich-Institut (PEI), the German ZLG (Central Authority of the States for Health Protection Regarding Medicinal Products and Medical Devices), the German Stem Cell Network (GSCN), Health Capital – the Healthcare Industries Cluster Berlin-Brandenburg and Berlin Partner.
Important note: The event language will be English, while for individual questions or topic discussions a switch to german is possible.
Programme – 20 November 2025 | 9 a.m. – 5 p.m.
Welcome address
Dr. Ralf Sanzenbacher
Paul-Ehrlich-Institut, Langen
Beta cell replacement therapies for Diabetes: Where do we stand?
Prof. Dr. Heiko Lickert
Helmholtz Zentrum Munich and Technical University Munich
Beremagene geperpavec: First approved topical gene therapy for dystrophic epidermolysis bullosa
Dr. Caspar Franzen
Krystal Biotech, Amsterdam/Berlin
Discussion
Coffee break
SoHO and Implementation in Germany: Update and Perspective
Janina Hahnosler / Dr. Irina Bosman
German Ministry of Health, Berlin
Decentralized ATMP manufacturing: Opportunities and challenges
Dr. Bernd Schröder
Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach
Discussion
Lunch
TIL-based cancer therapy and state of the art manufacturing of TILs
Prof. Dr. Markus Mäurer
Champalimaud Foundation and Botton-Champalimaud Pancreatic Cancer Center, Lisboa Portugal / Johannes Gutenberg University of Mainz
GMP Manufacturing of Cell and Gene Therapy Drugs at Point of Care – Suitable Facility Concepts and Scalable Solutions
Dr. Hans-Georg Eckert
Valicare GmbH, Frankfurt/Main
Discussion
Coffee break
Solutions for rapid bioburden, sterility and endotoxin testing: Update and general requirements
Stefan Gärtner
Labor L&S, Bad Bocklet
Comparison of interactions and submission pathways for ATMP in the US and EU: From pre-IND to marketing application
Dr. Thorsten Meyer
Granzner Regulatory Consulting & Services GmbH, Munich
Discussion
Résumé and end of symposium
All speakers and presentation titles are confirmed.
Speakers, presentation titles and speaker sequence are final, nevertheless may be subject to change if necessary.
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Participation fee: 240,00 €
A reduced participation fee of 50% applies to representatives of authorities. Please indicate your authority under „Remarks (Anmerkungen)“.
Student participation fee: 40,00 €. Please indicate your matriculation number under „Remarks (Anmerkungen)“.
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