Maastricht, The Netherlands – PharmaCell announced today that it has entered into an agreement with Dendreon Corporation (NASDAQ: DNDN) to be the Contract Manufacturing Organization (CMO) for the European commercial production of its recently approved cellular immunotherapy product Provenge® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion.
In September, the European Commission (EC) granted marketing authorization for Provenge in the European Union for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. In the United States, Provenge was approved in 2010 and is produced by Dendreon in its own manufacturing facilities.
Alexander Vos, chief executive officer of PharmaCell B.V. said, "We are extremely pleased that an immunotherapy industry leader such as Dendreon has decided to continue its relationship with PharmaCell. We have worked with Dendreon since 2011, and the decision to extend our relationship is a testament to the dedication and expertise of our team who have worked with Dendreon throughout the Technology Transfer and European approval process over the past few years."
PharmaCell is a leading European-based CMO active in the area of cell therapy and regenerative medicine. PharmaCell has experience in supporting Phase I-III clinical trials, as well as commercialization projects, in terms of manufacturing, QC, QP batch certification, storage, in-outgoing logistics. The company is exclusively focused on providing contract services in the area of human cell therapy. Its services include process and assay-development to ensure GMP compliance, robustness and scalability of cell therapy manufacturing processes. PharmaCell operates a state-of-the art cGMP certified facility situated in Maastricht, The Netherlands, centrally located in Europe. The facility covers 1400 square meters including clean rooms, grade A, B, C and D (Classes 100/10.000/100.000), R&D and QC laboratories including cryopreservation, warehouse and logistics areas. For more information about PharmaCell and its capabilities, please visit www.pharmacell.nl.