apceth is Granted a Manufacturer's Licence for Somatic Cell Therapy
News Aug 09, 2011
apceth is among the first companies in Germany to be granted a manufacturer's licence for the production of somatic cell therapeutics pursuant to Section 13, German Medicines Act.
"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 licence we can now achieve this target sooner and more effectively", said apceth CEO Dr Christine Günther.
The manufacturer's licence has been issued by the Government of Upper Bavaria and the Paul-Ehrlich-Institut. apceth and the authorities have jointly crossed genuinely new frontiers in drawing up the official conditions for this manufacturer's licence because very little experience has been gained with this innovative form of treatment to date.
"So we joined forces with the authorities to develop very stringent guidelines to ensure that stem cell therapeutics will also fulfil the highest quality demands in the future", explained Christine Günther.
"The licence not only enables us to produce somatic cell pharmaceuticals for our own needs, but also to take on our partners' development projects", added Helmut Jeggle, Managing Director und CFO.
Highly promising treatment options thanks to adult stem cell research
Adult stem cells possess a broad spectrum of biological properties that are based on the organism’s natural healing powers. For instance, autologous (the body's own) adult stem cells are capable of regenerating tissue and promoting wound healing.
One characteristic of these mesenchymal stem cells is that they do not trigger a reaction by the immune system, but instead regulate this system so as to dampen inflammatory processes. In allogenic use as well, (the stem cell donor and the recipient of the cells are different individuals) there are no rejection phenomena such as those known in standard transplantation medicine.
Adult stem cells can easily be harvested from human tissues for therapeutic purposes. Human bone marrow, adipose tissue, or umbilical cords contain the most stem cells. For this reason there are absolutely no ethical concerns about adult stem cells as opposed to embryonal stem cells.
Somatic and gene therapeutic cell therapy
apceth took two approaches during the development of its new treatment methods: somatic cell therapy and cell-based gene therapy. The somatic cell preparations are intended for application in regenerative medicine and are based on natural stem cells that have been isolated and propagated.
Modified cell therapy is planned for use in novel forms of cancer treatment. All apceth‘s cell products are subjected to the most rigorous controls with regard to their genetic stability and quality.
Research at the highest technical level
apceth produces its cell products under stringently controlled GMP conditions. To this end the company is equipped with highly advanced technological plants, representing a unique combination of GMP and S2 laboratories. The stem cell products are manufactured in Class C and B cleanroom suites with integrated Class A areas.
apceth's main cleanroom as well as the GMP/QC and the R&D laboratories are situated in the Munich suburb of Großhadern. Additional GMP premises have been equipped at the site in the Munich suburb of Ottobrunn.
The manufacture of cell preparations on the new GMP premises will start here in summer 2011. Thus, together with the GMP premises in Großhadern, apceth has a total of 600 m² cleanroom space at its disposal. These are divided into 5 separate cleanroom suites.