APCETH BIOPHARMA

apceth Biopharma is a pioneer in the field of cell and gene therapy and a leading European contract development & manufacturing organization (CDMO) for complex cell-based and gene therapy products (Advanced Therapy Medicinal Products, ATMPs) located in Munich, Germany. The company was founded in 2007 and is a wholly owned subsidiary of Hitachi Chemical Co., Ltd. since April 2019. apceth Biopharma is a well-established and highly experienced GMP contract development and manufacturing organizati... on (CDMO). The broad experience gained through pharmaceutical development and GMP production of their own innovative cell therapeutics, combined with the GMP infrastructure, form a firm basis for their successful CDMO activities. apceth Biopharma offers comprehensive contract GMP services for clinical and commercial stage Advanced Therapy Medicinal Products (ATMPs). This includes product and process development and associated GMP services for all types of complex cell and gene therapeutics. apceth Biopharma owns and operates two state-of-the-art GMP/BSL2 production facilities in Ottobrunn near Munich and in Munich / Großhadern (Germany). The facilities comprise 600 m2 of cleanroom area. Their GMP manufacturing process and facilities have been certified since 2010. They are fully compliant with all current EU regulations (ATMP regulation (EC) No.1394/2007) and ICH guidelines.More