Like all drugmakers with CAR-T cell therapies on the market, Gilead Sciences has had its fair share of roadblocks to commercial success––not the least of which has been a difficult manufacturing scale-up. Now, Gilead could be ready to take CAR-T therapy Yescarta to the next level with a long-awaited European production hub.
After years in the works, Gilead’s 117,000-square-foot CAR-T facility at SEGRO Park Amsterdam Airport is now fully operational after the European Medicines Agency (EMA) approved the plant’s end-to-end manufacturing process late last week.
The facility, operated by Gilead’s Kite unit, will house European production for cell therapy Yescarta, which won an EMA approval back in August 2018 to treat relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.
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Yescarta received its initial FDA approval in October 2017, just two months after Novartis’ Kymriah broke ground as the first CAR-T therapy approved for U.S. patients. The one-time therapy came with a lofty price tag of $375,000 per patient.
With an EMA nod in hand, Gilead forecasts the Amsterdam facility will be able to churn out enough of the pricey therapy for 4,000 patients each year. The plant’s placement at the Amsterdam airport will allow Gilead to streamline the complicated manufacturing process for Yescarta and help supply the drugmaker’s 90 qualified treatment centers across 15 European countries and Israel.
“This facility will benefit both patients and healthcare professionals, allowing Yescarta to reach European treatment centers more quickly and reducing the time it takes to reach patients by almost a week,” Kite CEO Christi Shaw said in a release.