Officials at Adaptimmune, which focuses on cell therapies targeting solid tumors, say the company has built in-house bioprocessing capabilities to avoid shortages in outsourcing capacity for cell and gene therapies when they started manufacturing autologous therapies four to five years ago.
“The CDMO market is growing, but at this stage there isn’t enough capacity for everyone who wants to take drug candidates into the clinic,” explains John Lunger, chief patient supply officer at Adaptimmune, adding that a new cell therapy company might face a twelve- to eighteen-month wait before a CDMO can begin work on their project.
Adaptimmune uses the manufacturing facility in Philadelphia for bioprocessing their autologous T-cell receptor platform for treating cancers (specific peptide enhanced affinity receptors, or SPEAR, T cells). They perform lentiviral gene transfer products at the U.K.’s Cell and Gene Therapy Catapult manufacturing center in Stevenage. In addition, they work with a trusted CDMO to cryopreserve samples from European patients.
According to Lunger, in-house manufacturing has helped Adaptimmune set out an ambitious development program for cell therapies.
“Cell therapies are different from other therapies because scientific understanding is exploding,” he says. “To address the challenges of these therapies, you need to take new hypotheses into clinic and adapt your processes. Using a third party for that rapid product innovation would be very challenging.”
As a result, Lunger says, the company has been able to rapidly expand their clinical trial capacity from one product in the U.S. four years ago, to multiple products at centers in France, Canada, Spain, the U.S., and the U.K.
“With a CDMO, it can take a couple of years to get into the queue, but we can have a hypothesis, do the science, and bring a drug candidate straight into the clinic,” he tells GEN.
By improving in-house processes and yields, and by building the new facility, Adaptimmune has also reduced their per-patient viral vector costs by 90% and their drug product manufacturing costs by 40% over the last five years, according to Lunger, who adds, “I think those cost reductions are going to continue.”