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Testing and Analytics of Cells, Tissues and ATMPs

13 November 2019

Objectives

This session 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 ells 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 framework 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.

  • Comparability with Compendial Methods
  • Greater sensitivity than previous methods (limit conflict with current requirements)
  • Possibility of further cultivation
  • Differentiation live/dead

Target Group

This seminar 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 responsilel for microbiological or analytical testing
  • Perform inspections or audits of ATMPs facilities
  • Deal with the authorisation

Programme

Suitability of the test method for the test ‘Microbiological Examination of cell-based Preparations’ according to EP 2.6.27
Dr Jörg Degen, Eurofins

RMM for sterility testing of an oncology cell therapy product using ATP bioluminescence
Dr Michael Miller, Microbiology Consultants LLC

Validation of a flow cytometry based quantitative lymphocyte immunophenotyping method to qualify cellular products for immune effector cells processing
Dr Claude Lemarié, Center for Cell Therapy Marseille

Microbiological testing of Cell Based Medicinal Products using automated growth based methods
Dr Antonio Rodríguez Acosta, Andalusian Initiative for Advanced Therapies

Challenges for cell-based medicinal products
Dr Ilona Kalaszczyńska, BMCT

Filling the gap – from bench to bedside
Dr Claudia Papewalis, Valicare

Cell Based Potency Assays: Analytical Considerations from a Regulatory Perspective
Dr Sigrid Roosendaal, Quality RA

Speakers

Dr Jörg Degen, Eurofins BioPharma Product Testing
Head of Microbiology.

Dr Ilona Kalaszczyńska, Medical University of Warsaw
Scientist at University Warsaw and QC Manager BMCT.

Dr Claude Lemarié, Center for Cell Therapy Marseille
QC Management.

Dr Michael J. Miller, Microbiology Consultants
Global expert in rapid methods, validation and pharmaceutical microbiology.

Dr Claudia Papewalis, Valicare
Senior GMP Consultant.

Dr Antonio Rodríguez Acosta, Andalusian Initiative for Advanced Therapies
Quality Manager and Deputy Qualified Person at Cell Manufacturing Unit (Regional University Hospital, Málaga. Spain).

Dr Sigrid Roosendaal, Quality RA
Senior Consultant.