apceth Biopharma is a pioneering clinical stage biopharmaceutical company and a successful 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 as apceth GmbH & Co. KG. It is owned by the investors and the scientific founders.
PROPRIETARY PRODUCTS & TECHNOLOGY
apceth Biopharma is harnessing the potential of mesenchymal stem cells (MSC) with the aim of providing innovative cell-based gene therapies for the treatment of major indications such as cancer, chronic lung and kidney diseases and for immunomodulation.
Our proprietary approach is based on genetic engineering of MSC. It could offer an effective therapy, with almost no side effects, able to circumvent the limitations and risks of standard therapies for severe diseases.
apceth Biopharma is the first company worldwide to obtain approval for the clinical testing of genetically engineered MSC in patients (indication solid cancer).
Since 2016 our MSC platform is based entirely on allogeneic MSC, obtained from healthy volunteer donors. apceth uses one healthy bone marrow donation to produce cell therapeutics for the treatment of many unrelated patients as clinic-ready off-the-shelf medications.
We at apceth Biopharma aim to:
- develop new treatments based on the state-of-the-art engineering of human mesenchymal stem cells, and introduce them in clinical application
- create cell therapy strategies that are more efficient, safer and have fewer side effects then current standards of care
- make innovative cell therapeutics available as clinic-ready cell therapy products to patients suffering from severe and incurable medical conditions
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