ATMPs – Hurdles and Achievements in Quality and Safety

Objectives

This conference track is intended for professionals involved in the development and manufacture of cells, tissues, cell- and tissue-based products and ATMPs.  The conference will address a range of manufacturing challenges, including GMP regulations, as well as quality control issues. It will also explore 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 medicine, 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. Following the entry into force of several regulatory guidelines, such as the European Directive 2007/1394/EC for ATMPs, these products were classified as medicinal products. Consequently, they must comply with the EU's requirements for medicinal products. Despite the biopharmaceutical industry's significant expansion in this field, many of these products are still 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 driven by the frequent occurrence of manufacturing conditions, such as the open manipulation of cells and tissues, which are necessary for obtaining such products at medical/surgical levels, or by the short shelf life of the 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
• are responsible for 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

 

You can find more detailed information at a later time.