By Chuck Calderaro, Global Head of Technical Operations
Kite opened its first cell therapy manufacturing facility in El Segundo, California to manufacture chimeric antigen receptor T (CAR T) cell therapy, with capacity to supply treatment to more than 4,000 patients per year, back in 2016.
CAR T is a personalized medicine that involves engineering a patient’s own white blood cells to fight cancer. This is a complex process and how rapidly each step of the process is completed has a direct impact on how quickly a patient can be treated. First, a patient’s T cells are removed via a process called leukapheresis. The cells are then flown to a manufacturing facility, routed through the manufacturing process, frozen and then shipped back to an authorized treatment center where they are thawed and reinfused into the patient. People who are eligible for CAR T therapy are typically severely ill and it is critical that this process happens as quickly as possible.
Through process improvements and the determination of our teams, we have been able to achieve an industry-leading manufacturing turnaround time in the United States since opening our first site four years ago. However, it quickly became apparent that replicating this same speed for patients outside the United States would not be possible as long as we did all of our manufacturing in California. The rate-limiting factor to how quickly we could provide treatment to patients in Europe and surrounding regions would always be the time it takes to ship a person’s cells to Southern California and back.
Our goal became clear: ensure that patients who are eligible for CAR T cell therapy can receive it as quickly as possible, regardless of location.
We recently reached an important milestone for patients around the world when our new manufacturing site in the Netherlands was approved for full operation. Our European manufacturing facility will allow us to supply up to 4,000 additional patients outside the United States with treatment per year. The site is strategically located just four miles from Amsterdam Airport Schiphol, allowing an individual’s cells to enter our manufacturing process and be rapidly shipped back to treatment centers across Europe for reinfusion.
This will help us shorten treatment timelines for Europeans with serious forms of blood cancer by almost one week – which is so important when dealing with patients who are so critically ill.
The 200,000-square-foot manufacturing facility nearly doubles Kite’s previous production capacity and makes it faster to provide treatment to people in Europe and the surrounding regions.
Our teams worked with incredible speed and dedication to construct, build out and qualify the facility with regulatory authorities since the site was identified in 2018. Approximately 240 construction staff worked a combined 350,000 hours to deliver a state-of-the-art facility in the span of two years, exceeding anticipated timelines. Reliability and sustainability were critical considerations in the construction of the facility, which has an on-site power plant, 1,800 rooftop solar panels and a design that maximizes natural light to reduce energy needs.
Most importantly, this expansion of our manufacturing footprint helps ensure that we are able to meet the needs of patients awaiting CAR T treatment today, as well as in the future. The opening of this new European facility is a testament to our continued commitment to transform the way cancer is treated for as many eligible patients as possible.
Chuck Calderaro is Kite’s Global Head of Technical Operations.