“The Product is the Process – Is it?” 2026: Manufacturing and Translation of ATMP and Tissue-& Cell-based products

Advanced therapy medicinal products (ATMPs) are in the focus of interest! We are proud to announce the 2026 edition of the conference focussing on ATMP since 2013.

Whether in regenerative medicine, cell or gene therapy – driven by remarkable research and clinical success, innovative therapy and product concepts based on ATMP are in the focus of interest.

Several products have achieved marketing approval and some ATMPs even reached broad clinical application. In addition, a 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 parts.

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 since 2013.

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.

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02 December 2026, 9.00 -17.00 h, Investitionsbank des Landes Brandenburg (ILB), Potsdam

Preliminary Programme and Speakers

All speakers and presentation titles are confirmed. Further speakers and speaker sequence will be announced in due time. The programme is subject to change.

Ralf Sanzenbacher, Ph.D., Paul-Ehrlich-Institut, Langen, Germany:

Welcome address

Prof. Agnete Kirkeby, Ph.D., University Copenhagen:

„Human pluripotent stem cell products in the clinic“

Pierre Springuel, Ph.D., Cell and Gene Therapy Specialist, Sartorius:

„Cell Therapy Platform Development: From design to qualification“

Vaneet Sabharwal, Ph.D., Thermo Fisher Scientific Life Technologies:

„Strategic raw material selection for ATMP commercialization“ (working title)

Dr. Marija Brgles, Boehringer Ingelheim Pharma GmbH &  Co. KG:

„Structural Complexity and Heterogeneity of Virus-Based Therapeutics: Does the Process Define the Product? Insights from VSV-GP Manufacturing“

Csaba Miskey, Ph.D., Paul-Ehrlich-Institut, Langen, Germany:

„Digging deep: „Advanced sequencing technologies for characterization of ATMPs: Strengths and limitations“

Prof. Gerald G. Schumann, Ph.D., Paul-Ehrlich-Institut, Langen, Germany:

„Genomic integrity in cell and gene therapy: Risk factors and product control“

All speakers and presentation titles are confirmed.

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