Paul-Ehrlich-Institut

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"The Product is the Process – Is it?" Manufacturing and Translation of ATMPs and Tissue & Cell-Based Products

An event held in cooperation with the Biotechnologieverbund Berlin-Brandenburg e.V. (BBB), the Paul-Ehrlich-Institut; the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukte, ZLG), the German Stem Cell Network (GSCN), HealthCapital – Healthcare Industries Cluster Berlin-Brandenburg, and Berlin Partner.

Begin

28.11.2024 09:00 AM

End

28.11.2024 05:00 PM

Location

Investitionsbank des Landes Brandenburg, Babelsberger Straße 21, 14473 Potsdam

Organiser

bbb e.V., Paul-Ehrlich-Institut, German ZLG, GSCN, HealthCapital

Summary

Dr Ralf Sanzenbacher from the Transfusion Medicine, Cell Therapy and Tissue Preparations Section at the Paul-Ehrlich-Institut initiated this symposium in 2011. In 2024 he once again took charge of selecting the conference topics, recruiting speakers, and moderating the event. Over 150 representatives from academia, clinics, private industry and public authorities exchanged views on developments and progress in cell-based immunotherapies at the event.

The keynote speaker was Professor Ulrike Köhl, Head of the Fraunhofer Institute for Cell Therapy and Immunology Leipzig.

The scientific lectures addressed the topic of cell-based innovative advanced therapy medicinal products. One focus was on the rapid development and progress of immunotherapies in oncology. These therapies use cells such as genetically engineered CAR-T cells, natural killer cells (NK cells) and tumour-infiltrating lymphocytes (TILs).

Several lectures reported from the clinical environment on work in molecular biological design and development, on complex pharmaceutical quality control requirements, and also on the challenges of scaling up necessary manufacturing on a larger scale.

Several lectures addressed regulatory issues. For example, the presentation by Dr Silvia Vogl from the Paul-Ehrlich-Institut on the new guidelines as well as initial experiences in the development of companion diagnostics (CDx). CDx play an increasingly important role, especially in personalised therapeutic approaches.

The event was rounded off by a presentation on the spread of novel pathogens and a report on the challenges in manufacturing advanced therapy medicinal products (ATMPs) in accordance with good manufacturing practice (GMP).

The next event is already scheduled for 20 November, 2025.

Group photo of speakers / organisers of the workshop Source: Biotechnologieverbund Berlin-Brandenburg e.V.