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Conference: Cells, Tissues and ATMPs – Quality Control

22/23 November 2022

Objectives

This conference is for cells, tissues, cell- and tissue-based products and ATMPs and deals with microbiological and analytical quality requirements, appropriate methods and test systems and their implementation. Representatives of authorities and colleagues from the small-scale and industrial manufacturing sectors will explain the current requirements and report on their experiences during inspections and implementation in the company.

Background

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 are a challenge for such short shelf life products in terms of:

  • Comparability with Compendial Methods
  • Sensitivity and Robustness
  • Suitability Testing and Validation
  • Variability

Target Group

This conference is aimed at all persons who

  • are involved in the extraction and manufacture of Cells, Tissues and ATMPs
  • Responsible persons from quality assurance and control of Cells, Tissues and ATMPs
  • are responsible for microbiological or analytical testing
  • perform inspections or audits of ATMPs facilities
  • deal with the authorisation

Programme - 22 November 2022

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, Molgenium

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 Therapies
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

Moderation

Dr Sabine Hauck, Leucocare

Speakers

Dr Anne Sophie Cottard, Yposkesi, France. Responsible of method validation and Analytical Life Cycle Management.

Dr Markus Fido, MFI Bio-Consulting, Austria. CEO.

Dr Sabine Hauck, Leucocare, Germany. Vice President Research & Development.

Dr Ulrike Herbrand, Charles River, Germany. Scientific Director Global in-vitro Bioassays.

Sidonie Karlsson, Amniotics, Sweden. Production Manager.

Dr Bechara Mfarrej, Institut Paoli-Calmettes, France. Research and Development engineer, Responsible Person in interim.

Dr Isabelle Moineau, AKTEHOM, France. Analytical Leader.

Sabrina Rottal, VelaLabs, Austria. Application Specialist - R&D and Analytical Development.

Dr Simon Schulz, Entourage, Germany. Senior Management Consultant.

Dr Mohamad Toutounji, Molgenium, Germany. Principal scientist for ATMP.