Seminar Nr. 20312
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Modern systems of regenerative medicines, such as cells and tissues or ATMPs (gene therapeutics, somatic cell-based products and tissue-based products) represent an innovative group of drugs that is becoming increasingly important. With the entry into force several regulatory guidelines e.g. of the European Directive EC 1394/2007 for ATMPs, such products were classified as medicinal products and must therefore comply as such with the EU requirements for medicinal products. Although the biopharmaceutical industry has considerably intensified its activities in this field, many of these products are developed and manufactured at universities, hospitals and in small and medium-sized enterprises. These university or medical roots lead to special challenges for the respective institutions as well as for the regulatory authorities in fulfilling the compliance requirements for quality, safety and GMP aspects and approval. This is also forced by frequently given manufacturing conditions, e.g. the open manipulation of cells and tissues, which are necessary for obtaining such products on a medical/surgical level or by the short shelf life of the obtained final product.
Rapid testing and analysis is a challenge for such short shelf life products in terms of:
This conference is aimed at all persons who
09.15 - 10.00 h
Congress Keynote: Biological Manufacturing – Demanding Quality and Compliance Requirements
Dr Tilman Rock, SVP, Site Head Vienna (Austria), Boehringer Ingelheim Biopharma
Welcome /Analytical Toolbox AAV Virus
Dr Sabine Hauck, Leucocare
Analysis Strategies for Cell and Gene Therapy Products
Dr Mohamad Toutounji, Sanofi
Personal Experience of Biological Raw Material Sourcing for an Early Stage ATMP and Considerations for later Clinical Stage Development
Sidonie Karlsson, Amniotics
Cells of Quality: ICH in the Lab - ICH S6, Q5A-D in the Context of Cell Banking Cell Substrates for the Production of ATMPs
Dr Simon Schulz, Entourage
Batch Release and Stability Studies, especially for ATMPs – a Challenge?
Dr Markus Fido, MFI Bio-Consulting
Bioactivity Testing for Cell and Gene Therapy Products
Dr Ulrike Herbrand, Charles River
Analytical Quality by Design Approach: a Challenge for Viral Vector Testing in Gene Therapy
Dr Isabelle Moineau, AKTEHOM
Dr Anne Sophie Cottard, Yposkesi
Automation of Hematopoietic Progenitor Cell (HPC) Processing: a Platform for ATMP Manufacturing
Dr Bechara Mfarrej, Institut Paoli-Calmettes
Development of a Cell-based Potency Bioassay for mRNA Medicine
Sabrina Rottal, VelaLabs