Gilead’s Kite building MD plant to support commercial CAR-Ts

A 20-acre site in Frederick, Maryland will support the production of Kite’s commercial CAR-T therapies, including Yescarta, from 2021.

Kite, acquired by Gilead Sciences for US$11.9 billion in August 2017, is one of only two firms to so far see regulatory success for a chimeric antigen receptor (CAR) T-cell therapy. Yescarta (axicabtagene ciloleucel) joined Novartis’ Kymriah on the market after being approved in October 2017.

To support Yescarta and its pipeline of CAR-T and T-cell therapies, the firm announced it is expanding its manufacturing network with a new facility in Frederick County, Maryland expected to begin commercial production by late 2021.

Image: iStock/gemenacom

“This new facility in Frederick County, MD will help ensure that we have the capabilities to meet the future production needs for cell therapies for people with cancer,” Kite spokesperson Shant Salakian told Bioprocess Insider.

“As we advance our industry-leading cell therapy pipeline, expanding and investing in our manufacturing capabilities is essential to ensuring we are able to meet the needs of CAR T patients today and the needs for cell therapies for people with cancer in the future.”

The facility will be built to Gilead/Kite’s own specifications and will become integrated within the company’s commercial manufacturing network. Finacial details of the new plant have not been disclosed.

East Coast, West Coast, Amsterdam

Yescarta is made by isolating peripheral blood mononuclear cells from a patient’s own white blood cells. These are sent to a manufacturing plant where the cells are stimulated to proliferate and combined with a retroviral vector and propagated in cell culture bags. They are the returned and infused back into the patient at a clinical center.

Kite’s network includes a 43,500 square-foot plant in El Segundo, Santa Monica, opened in 2016. The site has the capacity to treat 5,000 patients a year. Furthermore, Gilead acquired research facilities from Astellas Pharma, also located in Santa Monica, in April 2018.

And the following month – May 2018 – the firm announced plans to open a site in Hoofdorp near Amsterdam, The Netherlands expected to begin commercial production in 2020.

“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,” a Kite spokesperson told us at the time.

Essential for the rapid cold-chain logistics needed with personalized medicine, El Segundo also has good transport links (LAX airport), while the new Maryland facility is well-served by Washington-Dulles International airport.