Conference: Cell and Gene Therapies/ ATMPs - Quality and Safety

Objectives

Modern regenerative medicine systems such as cells and tissues or ATMPs (gene therapeutics, somatic cell-based products and tissue-based products) represent an innovative group of medicinal products that is becoming increasingly important. With the entry into force of several regulatory directives, e.g. the European Directive EC 1394/2007 for ATMPs, such products have been classified as medicinal products and as such must comply with EU requirements for medicinal products. Although the biopharmaceutical industry has significantly intensified its activities in this area, 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 meeting compliance requirements for quality, safety and GMP aspects and approval. The frequently given manufacturing conditions also contribute to this, e.g. the open manipulation of cells and tissues necessary for obtaining such products on a medical-surgical level, or the short shelf life of the obtained end product. There are also always potential conflicts regarding the relevance of different guidelines, e.g. when Annexes 1 and 2 or WHO guidelines do not align with the ATMP guideline.

Highlights

• Strategies for decentralized ATMP manufacturing
• Technological Innovations: NGS, Vector Packaging Technology
• Regulators Experiences and Expectations
• Insights into alternative approaches: Bacteriophages, specific quality control strategies for cell therapies

Moderators

Dr Sabine Hauck, Chair of the ECA ATMP Board
Dr Ulrike Herbrand, Charles River Laboratories