Munich, Germany, Aug 7, 2018 – apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, announced today that it has received an extended general manufacturing authorization by the District Government of Upper Bavaria. This manufacturing authorization for cell and gene therapeutics is now regulated on an activity-related and no longer product-related basis. The previously obligatory inspection by the regulatory authority becomes optional.
“We are very pleased with the trust and confidence shown by the regulatory authority”, commented Dr Christine Guenther, CEO of apceth Biopharma. “I am very proud of the entire apceth team, which has successfully completed every inspection by the District Government of Upper Bavaria and the Paul-Ehrlich-Institute since the foundation of the company. This kind of regulatory approval is rarely found for cell and gene therapeutics.”
The extended general manufacturing authorization includes the clinical as well as commercial supply of cell products with different manufacturing techniques. It allows the production of cell therapeutics from various starting materials, for example bone marrow and umbilical cord blood, the production of native and genetically modified cells as well as the autologous or allogeneic administration.
“This gives us more flexibility, streamlines the manufacturing approval process and shortens the timelines for our new customers”, explains Dr Andreas Schmiede, head of the Contract Development and Manufacturing department (CDMO). In 2018, apceth has also expanded its manufacturing capacities with two new class B clean rooms and is continuously strengthening its Manufacturing and Quality Control teams. “Due to the high demand for capacity for the CDMO business, we are significantly enhancing our capabilities to meet the growing need of our customers”.
About apceth Biopharma GmbH
apceth Biopharma is a pioneering company in cell therapies and regenerative medicine with an innovative portfolio of drug candidates for the treatment of inflammation, autoimmunity and solid tumors. apceth is developing two proprietary next generation gene therapy products, which are based on the introduction of therapeutic transgenes into mesenchymal stem cells (MSCs). apceth-201 expresses the immunomodulatory protein alpha-1 antitrypsin for the treatment of graft-versus-host disease. The company’s second program, apceth-301, expresses a potent immunostimulatory “cocktail” of cytokines, which locally activates the immune system to eradicate tumor cells. apceth-301 is currently being developed for glioblastoma as well as for other solid tumors.
apceth Biopharma is also a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities (ISO 5, ISO 7, ISO 8, BSL2 cleanrooms) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSC), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSCs) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent.
apceth Biopharma GmbH
Dr Christine Guenther, CEO
Phone: +49 (0)89 7009608 0