Moving into the Future with Advanced Therapies
ATMPs offer new therapeutic approaches for previously untreatable diseases
In the last decade, many novel medicinal products, also known as advanced therapy medicinal products (ATMPs), have been further developed and achieved breakthrough success.
Numerous gene therapeutics, cell therapeutics and bioengineered tissue products are already approved in the EU and the US, and many clinical trials are in progress worldwide.
This group of medicinal products represents according to the German Medicines Act (AMG) a heterogeneous group of preparations. By definition, they are biomolecules used as gene therapeutics, somatic cell therapeutics or bioengineered tissue products. They are primarily isolated from blood, bone marrow or other tissues as cells or nucleic acids, are modified for therapeutic purposes and subsequently used autologously or allogeneically.
Unlike a transplantation of tissue, such as supporting tissue, skin or hematopoietic stem cells, mostly all ATMPs have in common that their starting materials are substantially modified. Gene therapeutics (manipulated nucleic acids), genetically engineered cell therapeutics or customized and/or stimulated expanded cells are created.
