LONDON--(BUSINESS WIRE)--
Cell Medica, a leading T cell therapeutics company, today announced the opening of its European commercial manufacturing facility at the Max-Delbrck-Center of Molecular Medicine within the biotechnology park of Campus Berlin-Buch (Germany). This state-of-the-art facility for the GMP production of cell and gene therapies includes approximately 350 m2 clean room 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 immunocompromized following allogeneic hematopoietic stem cell (bone marrow) transplant. The commercial launch of this product is planned in early 2014 and will confirm Cell Medicas position as one of the leaders in the development and market delivery of T cell therapeutics a new paradigm for the treatment of cancer and infections.
Dr. Rainer Knaus, Managing Director of Cell Medica GmbH and Head of the Companys global manufacturing operations, commented: This facility has been designed and equipped to provide high quality GMP compliant production of patient-specific cell and gene therapies for distribution across Europe. We are also very fortunate to have attracted highly educated and well-trained personnel who are keen to help shape this new era of cell-based therapeutics, says Dr. Knaus. These manufacturing specialists are preparing the facility for the supply of Cytovir CMV in early 2014.
The facility in Berlin-Buch will also be important for Cell Medicas planned CITADEL study for the investigation of Cell Medicas T cell therapy for the treatment of EBV-associated lymphomas. The provision of investigational medicinal products for European study centers will be undertaken following the required regulatory approvals.
The financing of Cell Medicas investment in the Berlin-Buch facility is supported in part by the Investitionsbank Berlin (IBB), the business development and promotional bank of the Federal Land of Berlin.
Notes toEditors
About CellMedica
Cell Medica is a cellular therapeutics company engaged in the development, manufacturing and marketing of T cell immunotherapy approaches for the treatment of infections and cancers related to oncogenic viruses. The Companys lead cell product, CytovirCMV, for the treatment and prevention of cytomegalovirus (CMV) infections in patients following allogeneic bone marrow transplant, is available in the UK and is under development in other territories. Cytovir ADV is being developed for the treatment of adenovirus infections in pediatric patients following bone marrow transplantation. Cell Medica is also working with the Center for Cell and Gene Therapy, Baylor College of Medicine, to develop a cancer cellular therapeutic for the treatment of malignancies associated with the oncogenic Epstein BarrVirus.
About T cellimmunotherapy
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Cell Medica opens a central European manufacturing facility in Berlin–Buch (Germany)
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