Dendreon says its experience bringing Provenge to market puts it in good stead to offer its process development, manufacturing, and patient logistics capabilities to other cell therapy makers.
Dendreon has had a turbulent past. Its autologous cell therapy product Provenge (sipuleucel-T) was approved in the US in 2010 for the treatment of prostate cancer but manufacturing complexities and costs led the firm to restructure itself in 2012, including selling its Morris Plains, New Jersey to Novartis.
The latest chapter in the firm‚Äôs story sees it launching itself into the third-party space, investing in contract manufacturing and patient services for cell therapy partners.
‚ÄúDendreon established a contract manufacturing and services division to fill an expertise gap in the cell therapy market, as there is currently insufficient capacity to meet anticipated industry demand,‚ÄĚ Dendreon‚Äôs CEO, Jason O‚ÄôNeill told Bioprocess Insider.
He added the firm will leverage Dendreon‚Äôs decade of expertise in cell therapy manufacturing to support the burgeoning sector.
‚ÄúAs one of only four companies manufacturing cell therapies for commercial use in the US, Dendreon understands the complexities of cell therapy manufacturing as well as supply chain and patient logistics. We will leverage our unique process development, manufacturing, and patient logistics capabilities to deliver unparalleled support to our strategic partners.‚ÄĚ
So far, the response to this offering has been ‚Äúoverwhelmingly supportive both from cellular therapy development companies as well as the investment community,‚ÄĚ he told us, adding Dendreon is already in discussions with a few potential partners.
Dendreon will continue to manufacture Provenge. (Last year, the firm extended the lease on its Atlanta, Georgia facility through to 2029.)
Thus, to support the CDMO business, Dendreon will segregate and invest in its facilities and business support infrastructure to manage the new responsibilities, O‚ÄôNeill said.
‚ÄúDendreon‚Äôs 180,000 square foot cGMP-compliant and FDA-approved manufacturing facility in Seal Beach, California will serve as the contract manufacturing services hub. Our Seattle facility will serve as the tech transfer and process development center.
‚ÄúWe began investing in dedicated capacity for later-stage partner programs within our existing infrastructure in early 2021. Over the next year, Dendreon will make additional investments in its contract manufacturing and patient services division.‚ÄĚ