apceth is Granted a Manufacturer's Licence for Somatic Cell Therapy
New manufacturing capacity established in Ottobrunn near Munich
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 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.
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