The GMP facility will be at the Max-Delbrück-Center of Molecular Medicine, Berlin-Buch, Germany
Specialist T cell therapeutics company, Cell Medica is opening a European commercial manufacturing facility at the Max-Delbrück-Center of Molecular Medicine within the biotechnology park of Campus Berlin-Buch, Germany. The facility for the GMP production of cell and gene therapies includes approximately 350 m2 cleanroom space.
Initial manufacturing will focus on Cytovir CMV – an innovative treatment which uses the immune cells of a healthy donor to restore viral immunity against cytomegalovirus infections in patients who are immunocompromised following allogeneic hematopoietic stem cell (bone marrow) transplant. The commercial launch of this product is planned in early 2014.
The facility will also be important for Cell Medica’s planned CITADEL study for the investigation of Cell Medica’s T cell therapy for the treatment of EBV-associated lymphomas.
Cytovir CMV is available on clinician’s request in the UK only. In Germany, the competent authority has confirmed that Cytovir CMV can be placed on the market under a manufacturing license.