Gilead to Open European Plant to Support CAR-T Manufacture

The site near Amsterdam, The Netherlands will be Gilead Sciences/Kite’s third manufacturing facility to support production of its cell therapies.

“The site in Hoofddorp will be Kite’s manufacturing base in Europe, enabling Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe,” Gilead spokesperson Sarah Swift told BioProcess Insider.

When operational in 2020, the 117,000 ft² site will provide 300 new jobs.

Gilead Sciences entered the cell therapy space last August through the US$11.9 billion (€10 billion) acquisition of Kite Pharma.

Weeks later, lead candidate Yescarta (axicabtagene ciloleucel) became only the second chimeric antigen receptor (CAR) T cell therapy to receive US Food and Drug Administration (FDA) approval.

The therapy is currently under review by the European Medicines Agency (EMA).

Yescarta Manufacturing

Yescarta is made by isolating peripheral blood mononuclear cells, including T-cells, from a patient’s own white blood cells. These are sent to one of Gilead/Kite’s manufacturing facilities where they are stimulated to proliferate and combined with a retroviral vector, propagated in cell culture bags, before being infused back into the patient at a clinical center.

In 2016, Kite opened a 43,500 ft² plant in El Segundo, Santa Monica with capacity to treat up to 5,000 patients a year. In April, Gilead acquired research facilities from Astellas Pharma, also located in Santa Monica.

Furthermore, the firm has leased a 26,000 ft² plant in Gaithersburg, Maryland to support a new Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) aimed at developing cell therapies targeting patient-specific tumor neoantigens.

“The opening of a new European facility marks a continued expansion in Kite’s global footprint following the recent announcements of new facilities in both Maryland and Santa Monica in the US,” Swift said.

Transport Links

Cold-chain logistics is important for many biopharmaceuticals, but for personalized medicines it is somewhat crucial as the patient is part of the supply chain. The process is also time-dependent and so having reliable and close transport links is key.

Therefore, like the decision to invest in El Segundo due to its proximity to LAX airport, Hoofdorp is located close to Amsterdam’s Schipol airport.

“The location of Hoofdorp (was chosen due to its central European location and favorable transport links which will enable personalized cell therapies to be manufactured in close geographic proximity to the patients who will receive them.”