The first product has been manufactured and delivered to the patient
Cell Medica, a cellular immunotherapy company based in London, UK, has begun commercial cell therapy manufacturing at its facility at the Max-Delbrück-Centre of Molecular Medicine in Berlin-Buch, Germany.
The first product has been manufactured and delivered to the patient, the company said.
Manufacturing at the site will initially be focused on Cytovir CMV, which is used for the treatment of cytomegalovirus (CMV) infections in patients after a haematopoietic stem cell (bone marrow) transplant. The product consists of naturally-occurring donor cytotoxic T cells to restore viral immunity against CMV and is individually manufactured for each patient.
Manufacturing of Cytovir CMV is in a closed system which contains the cell product within aseptic conditions throughout the process and allows high-volume, cost-efficient production, the company said.
Cell Medica acquired the GMP production facility in Germany in 2013 and received a commercial manufacturing licence for the new closed system last November.
Gregg Sando, CEO of Cell Medica, said: 'This facility has been designed and equipped to provide high quality GMP-compliant production of patient-specific cell therapies for distribution across Europe. We are very excited to have taken our lead product from early development into commercial sales with an industrial-scale manufacturing system. We are among the very first companies in the world to have demonstrated this capability.'