ATMPs are exceptional because they offer groundbreaking new opportunities to cure broad indications such as cancer with mechanisms naturally available in the body and without serious side effects.
They are exceptional because of their very special and individualized manufacturing process, the limited availability of the starting material, the very small batch size and the need of individualized technical solutions without the degree of automation or the use of production lines that is usual in today’s pharmaceutical production.
Furthermore, they are exceptional because of the inherent variability of the starting material, often living cells from patients, which have to be expanded and processed under cell culture conditions to develop therapeutic effects. Moreover, ATMPs require exceptional services, because they are manufactured in cleanrooms for individual therapy options and for small collectives, with a high claim of quality and a high flexibility in the manufacturing process.
ATMPs also require exceptional demand on regulation, as they represent pharmaceutical products. There is a serious public interest to ensure the quality of these products warranting patient`s safety. And even in this field, ATMPs are special: The Guidelines on Good Manufacturing Practice for Pharmaceuticals (GMP), which are the basic principles of pharmaceutical manufacturing in general, were supplemented with the new ATMP-specific Part IV that has been adopted in the EU in 2017 and became mandatory in May 2018. This was a logical and necessary step, as many details of the classic GMP rules could not be applied to these new products. Consequently, the progress was also well-supported by Germany’s higher federal authority in this field, the Paul Ehrlich Institute.
Finally, ATMPs are also exceptional in their approval processes. All advanced therapy medicines have to be approved centrally via the European Medicines Agency (EMA).
Valicare GmbH is a well-versed partner for ATMP developers and producers supporting consulting services and providing additional value in the implementation of these regulatory requirements. Valicare offers special GMP service support for ATMPs.
Dr. E. Sons-Brinkmann
Phone: +49 69 7909 350