Date: 2018-08-07
Type of information: Production agreement
Compound:
Company: apceth (Germany)
Therapeutic area: Technology - Services
Type agreement: validation of a production plant
Action mechanism:
Disease:
Details:
- • On August 7, 2018, apceth Biopharma announced 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. 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.
- 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.
Financial terms:
Latest news:
Is general: Yes
