apceth granted German licence to produce somatic cell therapeutics
13 August 2011
Munich-based apceth has become on of 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
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 guidlines 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
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. Modifed 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 stabilty 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