Cell Medica, a T cell therapeutics company, has opened a European manufacturing facility in Berlin-Buch, Germany to develop, manufacture, and market treatments of infections and cancers related to oncogenic viruses.
Cell Medica’s commercial manufacturing facility at the Max-Delbrück-Center of Molecular Medicine within the biotechnology area of Campus Berlin-Buch includes approximately 350 m2 cleanroom space, and will initially focus on manufacturing the company’s Cytovir CMV. The Cytovir CMV treatment uses immune cells of a healthy donor to restore immunity to Cytomegalovirus infections in patients who have lost their immunity following a bone marrow transplant. The commercial launch of Cytovir CMV is planned for early 2014, following the completion of two randomized controlled studies currently ongoing in the UK.
The facility will also be important in providing investigational medicine products for Cell Medica’s planned CITADEL study to investigate a T cell therapy for the treatment of EBV-associated lymphomas, which will be undertaken following the required regulatory approvals, the company reports.
Source: Cell Medica