The somatic cell preparations – based on natural stem cells that have been isolated and propagated – have applications in regenerative medicine, such as novel forms of cancer treatment.
However manufacturing licenses for the therapy have been a largely no-go area because the treatment is still relatively unexplored.
Now with the new conditions, in accordance with Section 13, German Medicines Act, the Munich-based company hopes to bring its stem cell technology to clinical application more quickly and efficiently.
A spokesperson for the company said: “apceth and the authorities have jointly crossed genuinely new frontiers in drawing up the official conditions for this manufacturer's license because very little experience has been gained with this innovative form of treatment to date.”
Christine Günther, CEO at apceth, added: “Our aim is to develop innovative cell therapeutics and to close the gap between research and clinical application.
“Thanks to the opportunities offered by the manufacturer's license we can now achieve this target sooner and more effectively.”
As apceth and the German authorities have together trodden previously unmarked grounds with the new license, they have worked together to set a precedence by creating “stringent” official conditions.
Günther added: “We joined forces with the authorities to develop very stringent guidelines to ensure that stem cell therapeutics will also fulfill the highest quality demands in the future.”
The new regulations will also allow apceth to expand its projects for its partners; research organisations Fraunhofer Institut and the Helmholtz Zentrum in Munich.
Helmut Jeggle, apceth managing director and CFO, added: “The licence not only enables us to produce somatic cell pharmaceuticals for our own needs, but also to take on our partners' development projects.”