The manufacturing process of personalized cell therapies is more complex than mass production of traditional drugs.
The location is also extremely important which affects turnaround time.
Yescarta Manufacturing
Kite’s original lease of a 18,000 sqft site in Santa Monica supported its clinical trials while its 43,500 Los Angles facility opened in 2016 was designed for commercialization launch.
The El Segundo site is estimated to have the capacity to produce up to 5,000 patient therapies per year. The plant’s location, adjacent to Los Angeles International Airport, is intended to expedite receipt and shipment of engineered T-cells from and to patients across the United States and Europe. According to Kite, the time from when a patient’s materials are shipped to the facility to when the engineered T cells are returned to the patient is approximately 14 days.
When Yescarta was approved in Oct 2017, Gilead’s statement said in the ZUMA-1 pivotal trial, Kite demonstrated a 99 percent manufacturing success rate with a median manufacturing turnaround time of 17 days, which is important to patients given the potential for rapid disease progression in this population.”
In 2018, three month before Yescarta is approved in Europe, Kite leased a new facility in the Netherlands to engineer cell therapies in Europe – a 117,000 square-foot site in Hoofddorp (SEGRO Park Amsterdam Airport). The plant is expected to be operational in 2020 and saving 3-4 days in delivery (from Europe to LA). The current time including international delivery, from apheresis to delivery of Yescarta, is 26-29 days.
Meanwhile, in addition to the Netherlands facility, Kite said it had recently purchased a new building in Santa Monica from Astellas Pharma Inc. that will be used for cell therapy research, development and the expansion of clinical manufacturing capabilities, and has leased a 26,000 square-foot facility in Gaithersburg, Maryland.
In July 2018, it also added Michael Amoroso as Senior Vice President and Head of Worldwide Commercial, Cell Therapy. Mr. Amoroso was leading Ensai’s American commercialization of oncology business; but more importantly, he worked at Celgene on several oncology roles before serving as Commercial Lead, Global Marketing for Celgene’s CAR T programs. His current title is CMO of Kite.
In April 2019, Kite announced plans for a new 20-acre site in Frederick County, Maryland. Kite bought the 20-acre Urbana site in November 2018 for $7.5 million. The facility will have 62,000 square feet of office space and 217,000 square feet of manufacturing, plant, and shipping space.
On Gilead’s 2019 1st quarter earnings call, its new CEO said they will separate Kite into its own business unit.
In July 2019, Kite announced that Christi L. Shaw will join as CEO of Kite. Ms. Shaw was serving as Senior Vice President of Eli Lilly &. Co., and President of Lilly Bio-Medicines.
Later in July 2019, Kite announced plans for a new 67,000-square-foot facility in Oceanside, California, dedicated to the development and manufacturing of viral vectors, a critical starting material in the production of cell therapies. The facility will go live in the second half of 2021.