apceth is one of the leading European pioneers in the development, manufacturing and clinical implementation of innovative cell therapeutics. apceth’s unique platform technology employs human adult stem cells in order to produce cell products of the highest quality according to the EU regulations for Advanced Therapy Medicinal Products (ATMPs). The growing portfolio of apceth’s cell therapeutics aims for the treatment of advanced cancer and various nonmalignant diseases where standard medicine fails to achieve satisfactory results.
apceth exerts full control over the pharmaceutical development of its cell therapeutics, starting from R&D and preclinical phases to GMP production under quality management system and clinical testing. This enables apceth to accelerate the translation of innovative ideas and basic research into revolutionary novel cell therapeutics in the shortest time possible for the benefit of patients and their physicians.
apceth employs established quality management system for production of the cell products. The manufacturing, quality control and quality assurance are carefully integrated into the quality management system. The final cell product will be released by apceth’s certified Qualified Persons. In this way apceth guarantees a robust manufacturing process and an exceptional and consistent batch-to-batch quality of every cell product.
With its proven know-how in development and manufacturing of ATMPs and the state-of-the-art production facilities, apceth offers a range of GMP services to customers from industry and academia worldwide. As one of the very first companies in Germany apceth is in possession of the manufacturing license according to §13 of the German Medicines Act (AMG) for production of clinical grade somatic cell therapeutics according to the European ATMP regulation (EC) No. 1394/2007.
apceth was founded in 11/2007 as a biopharmaceutical start-up company initially financed by ATHOS Service GmbH (Munich), a family office and investor with long-lasting experience in the pharmaceutical business. Currently apceth has two manufacturing locations in Munich / Grosshadern and Munich / Ottobrunn, and a USA-based office.
Currently apceth is running the clinical trial phase I/II with the somatic cell therapeutic Alecmestencel-T for the treatment of critical limb ischemia. Another phase I/II clinical trial with apceth’s modified somatic cell therapeutic Agenmestencel-T for the cancer therapy will begin in 2013.