Celgene, which is working on multiple fronts in the frontier of CAR-T drugs, says it has completed the first phase of a new manufacturing facility to produce the drug candidate it is developing with partner Bluebird Bio.
So far, Celgene has produced clinical materials for the effort in a lab at its facility in Warren, New Jersey. But this week, the company said it has completed the first phase of a 135,000-square-foot cellular immunotherapy manufacturing facility that is housed in a renovated portion of its Summit West campus.
The facility will initially be used to manufacture product for expansion of its investigational programs with drug candidate bb2121, the CAR-T therapy being developed with Bluebird Bio to treat certain multiple myeloma patients. If the the treatment is approved, then the facility will be ramped up for a commercial launch.
A spokesman in an email today said that the budget for the renovation is more than $130 million and the company expects over the next three years to add 500 jobs there.
With CAR-T technology, immune cells are taken from a patient, cryopreserved, shipped to a facility, reprogrammed and manufactured in the lab to create an individualized therapy, and then shipped back for infusion into the patient. All of that has to happen in the shortest time possible to try to outrun aggressive cancers.
“We wanted to ensure that we had a patient-centric model that supports our goal of flawless execution and rapid, compliant production,” Mayo Pujols, VP of CAR-T manufacturing for Celgene. “We aim to see every patient getting their therapy back in that manner and so it made sense for us to build the capability in house.”
Celgene's effort with Bluebird was overshadowed somewhat last month when the big biotech struck a $9 billion deal to buy Juno Therapeutics and its CAR-T candidates. That includes lead CAR-T JCAR017, which is in phase 1 for non-Hodgkin’s lymphoma. Celgene believes it could generate up to $3 billion a year in sales, assuming it gets FDA approval next year.
Celgene already owns a little under 10% of Seattle-based Juno and has collaborated with the CAR-T specialist since 2015, when they signed a 10-year collaboration to develop treatments for cancer and immune diseases. Juno, however, has its own manufacturing facility in Bothell, Washington, where it produces clinical material and where it plans to produce commercial scale product.
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Celgene has not said exactly how the manufacturing from those two efforts will mesh. When asked last month during Celgene’s earnings call if there could be manufacturing synergies between the efforts, COO Scott A. Smith suggested the company will run two separate manufacturing operations.
“Nothing really changes” with the Juno deal, he said. “There was a partnership that existed before this deal with Juno and with Bluebird. The partnership has changed in structure, but there were firewalls in place and the fundamental synergies that existed in areas that we couldn't discuss still remain the same post-acquisition.”
The Celgene spokesman today reiterated that the manufacturing facility in New Jersey will have nothing to do with other CAR-T programs, like with Juno, if those are completed.
Celgene is expanding in a market where the FDA so far has approved only two therapies, Novartis’ Kymriah and Yescarta from Kite Pharma, which Gilead acquired last year in a $12 billion deal.