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Diosynth Enters Supply Pact with Dendreon

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Diosynth Biotechnology has entered into a long-term commercial supply agreement with Dendreon Corp. for the manufacture of the recombinant antigen component of Provenge, Dendreon’s investigational immunotherapy for prostate cancer. The product will be manufactured for market launch and commercial sale in the Diosynth Biotechnology facility in North Carolina. Subsequent manufacturing may also be done at Diosynth’s large-scale cell culture facilities in the Netherlands.

This agreement reflects a continuing collaboration between the two companies beginning with the initial agreement for process development and scale-up through the more recent manufacture of conformance lots. “We value the ongoing confidence Dendreon has in Diosynth, entrusting us to provide commercial supply for Dendreon’s leading product candidate,” said Frank Tielens, president, Diosynth Biotechnology. “In addition to our industry-leading custom process development, analytical characterization and cGMP manufacturing of recombinant molecules, Diosynth contributes significant value through its expertise in scale-up and cGMP manufacturing with the Baculovirus expression system.”

Provenge is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient’s immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. Provenge is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer.

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