Modern systems of regenerative medicines, especially ATMPs (gene therapeutics, somatic cell-based products, and tissue-based products) represent an innovative group of drugs which is becoming increasingly important.

With the introduction of several regulatory guidelines e.g. of the European Directive EC 1394/2007 for ATMP, 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 companies. These university or medical origins result in 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 underlined by commonly occurring operating 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.

This results in a whole range of extraordinary requirements:

•  the consideration of later requirements during development and in clinical phases
•  the implementation of quality assurance requirements during aseptic production
•  the use of alternative methods for analysis and microbiological control and the demonstration of comparability with conventional methods
•  the handling of out of specification (OOS) / and out of limit (OOL) results during product testing and the possibility of batch release

Don't miss this opportunity to hear from representatives of regulatory authorities, experts from small-scale and large-scale production, QC laboratories, and consultants as they report on their practical experiences. From the construction of a new production facility to the introduction of a quality system and the final sterility test, all relevant topics directly related to ATMPs will be covered.