Netherlands-based PharmaCell has entered into an agreement with Dendreon to be the contract manufacturing organization (CMO) for the European commercial production of its recently approved cellular immunotherapy product Provenge dispersion for infusion.
Provenge is an autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T.
The product had received marketing authorization from the European Commission (EC) in September 2013 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.
Provenge was approved in 2010 in the US and is produced by Dendreon in its own manufacturing facilities.
PharmaCell CEO Alexander Vos said, “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.”
