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.
CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATION (CDMO)
apceth Biopharma is a well-established and highly experienced GMP contract development and manufacturing organization (CDMO). The broad experience gained through pharmaceutical development and GMP production of our own innovative cell therapeutics, combined with the GMP infrastructure, form a firm basis for our 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.
Our 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.
We are proud of our track record as an expert, high-performing GMP partner for a number of international clients from big pharma to biotech and academia.
- With manufacturing teams at the ready, we are able to fulfil the needs of all our clients’ developmental processes and clinical trials.
- We regulate the manufacture of each product to follow the needs of on-going clinical trials and the pace of trial recruitment.
- Centrally located in the heart of Europe, apceth Biopharma is able to supply rapidly IMPs and other products across the continent.
GMP SERVICES FACT SHEET