With cell and gene therapy boom coming, experts at Novartis, Kite trumpet need for capacity: panel

Cell and gene therapy has evolved into one of the biopharma industry’s hottest markets with a major splash of investment and a run of approvals likely in the coming years. To meet what’s likely to be massive demand for manufacturing capacity, industry experts are calling for “forward-looking” investments—but as one pointed out, those checks aren’t easy to write.

During a virtual roundtable Monday hosted by FiercePharma, manufacturing experts from Novartis, Gilead’s Kite unit, BioMarin and Astellas’ Audentes said building capacity and figuring out how to scale production would make the difference in whether the industry will be ready to handle a slate of expected approvals. 

According to former FDA Commissioner Scott Gottlieb, the agency could approve between 10 and 20 cell and gene therapies a year through 2025 with as many as 800 such therapies moving through drugmakers’ pipelines. 

Chuck Calderaro, Kite’s global head of technical operations, said Kite’s primary concern was how to scale production of its cell therapy offerings, including Yescarta, the company’s only approved therapy in the space.

VIRTUAL ROUNDTABLE: Up to the Challenge: Manufacturing’s Central Role in the Cell- and Gene-Therapy Revolution (reg. req’d)

Calderaro noted that Kite has a turnaround time of 16 days from patients having their blood drawn to infusion—and the drugmaker is hoping to keep that figure stable as its manufacturing chain grows. 

“Access to capacity is always a challenge in a growing area, and especially in cell therapy, which is personalized to order,” Calderaro said. “The challenge for us is to be able to scale that excellence as we begin to globalize our cell therapy treatments.” 

The first challenge for Gilead will come from bringing its newest facility in Amsterdam online after the EU gave it the go-ahead earlier this month.