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Quality Control of Cells, Tissues and ATMPs

11 November 2020

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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 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 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
  • Sensitivity and Robustness
  • Suitability Testing and Validation
  • Variability

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