SANTA MONICA, Calif.– Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.
The Maryland site joins Kite’s existing manufacturing facilities in Southern California and Amsterdam, Netherlands to form the largest, dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing. With today’s announcement, and through a variety of optimization efforts across Kite’s global CAR T-cell therapy manufacturing network, Kite estimates network capacity will be increased by 50%, enabling more patients to be served now and in the future.
“The FDA approval of our Maryland site marks an important milestone within our global CAR T-cell therapy manufacturing network, and will enable us to significantly expand our production capacity and further strengthen our ability to meet the needs of people living with difficult-to-treat blood cancers,” said Christi Shaw, Chief Executive Officer of Kite. “Manufacturing is central to every decision we make at Kite. Our teams hold patients’ cells in their hands every day, which could mean the difference between getting a chance to live or possibly losing their battle with cancer. It must be fast and extremely high quality to give patients the best outcome.”
CAR T-cell therapies are individually manufactured for each patient using their own T-cells extracted from their white blood cells. The patient’s T-cells are sent to Kite’s manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR) to recognize, attack and destroy their cancer cells. Once the individualized therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient. Unlike most cancer treatments, CAR T-cell therapy is a one-time treatment, available through authorized treatment centers (ATCs), or hospitals, that have experience with CAR T-cell therapy. Kite therapies are available at over 275 ATCs around the world, including more than 110 leading cancer hospitals in the U.S.
Kite began construction of the 275,000 square foot facility in Maryland on 20 acres in 2019. The site has unfinished space to add future capacity, which will allow Kite to accommodate potential new scientific and technological advances in the field of cell therapy. The new Maryland facility is purpose-built for cell therapy, incorporating learnings from across the Kite manufacturing network as well as incorporating automation for some previously manual processes, allowing more therapies to be produced to meet growing patient demand.
“As the global leader in cell therapy, it is important to keep innovating as manufacturing in cell therapy is unlike anything else in the biologics or pharmaceutical space – each production run is made to order for one patient – and we do it at scale, with a 96% success rate in returning our specialized treatments on time and to specification,” said Charles Calderaro, Kite’s Global Head of Technical Operations. “Manufacturing quality, reliability, and speed are critically important to us as we know patients are waiting. Our median cycle time is industry leading at 16 days in the U.S., from apheresis to finished product, which includes many processes that are heavily regulated for safety.”
The company is invested in the future of the cell therapy workforce and anticipates having more than 400 employees working at the Maryland site by the end of 2022. The site is also committed to training and developing the region’s cell therapy talent through partnerships with local academic institutions as well as community and government organizations.
Kite’s manufacturing and process development expertise in cell therapy make it a partner of choice, and this expertise is a key component of partnership pipeline deals for the next generation of cell therapies, including previously announced deals with Appia Bio and Shoreline Biosciences.
