ATMP - Hurdles and Achievements in Quality and Safety

Registration

Objectives

This conference track is aimed at all those who develop and manufacture cells, tissues, cell- and tissue-based products and ATMPs.  The conference will address manufacturing challenges, e.g. GMP regulations, but also quality control issues, appropriate ways to maintain, assure and control the expected quality.  Experienced speakers from the field of ATMP will explain the current requirements and report on their experiences during inspections and the 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.

Challenges for small batch manufacturing, rapid testing and analysis and storage are only some of the challenges for such short shelf life products in terms of:

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

Target Audience

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