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Navigating CDMO Capacities & Capabilities

“Audrey Greenberg says that among those cell and gene therapy companies choosing to outsource, about half of them do so in hybrid fashion, often through a co-location arrangement with organizations like the center For Breakthrough Medicines. “The R& D and tech transfer processes are quite cumbersome, so co-location has many advantages to streamline that path to commercialization,” she says. “With cell and gene therapy, it’s all about speed to market. Co-location typically eliminates a lot of the speed bumps that would take place along the way in a purely outsourced or do-it-yourself environment.”

Those speedbumps, says Greenberg, include a shortage in bioreactors, consumables, analytical methods, and the talent required to handle it all. She says a good CDMO partner will have access to not just material supply and manufacturing capacity, but also process and manufacturing expertise.

They hybrid model is one that Verma has embraced for Iovance. “We’ve partnered with various CDMOs over the past couple of years to support our clinical programs and products and our supply chain network, and that’s blossomed into a diverse and talented group of partners in the U.S. and Europe that’s helped us to make ground in advancing our company’s growth trajectory,” he says. “We’ve benefitted from access to the technologies and sciences needed for TIL therapies. While we have brilliant individuals in our Tampa facility performing the benchtop and lab work associated with our proprietary TILs, we weren’t sure that we could do this on our own.””

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November 3, 2021