Kite receives FDA approval for commercial production at California viral vector facility
The Gilead company says the approval makes it the only cell therapy company with in-house viral vector manufacturing capabilities for both clinical trials and commercial products. Furthermore, it strengthens the company’s global CAR T-cell therapy manufacturing network as it sees growing demand for its blood cancer treatments.
'This milestone is several years in the making'
Over 10,000 patients have been treated with Kite’s CAR T-cell therapies globally through more than 300 authorized treatment centers around the world, including 117 cancer hospitals in the US.
Viral vectors are key components needed to manufacture Kite’s cell therapies to treat certain blood cancers. These CAR T-cell therapies are one-time treatments individually made starting from a patient’s own T-cells.
“The FDA approval of our [Oceanside] commercial viral vector manufacturing facility further strengthens our global cell therapy manufacturing network with the addition of an in-house capability to produce a crucial element in the CAR T process, which is especially important as patient demand continues to grow,” said Kite's CEO Christi Shaw. “This milestone is several years in the making and reflects our continued commitment to, and investment in, bringing the curative intent of cell therapy to patients.”
The 100,000 square foot space at the Oceanside facility employs around 100 people. Furthermore, the capabilities and operations are fully scalable and will allow the company to accommodate additional vector manufacturing as cell therapy science advances.
Viral vectors and CAR T-cell therapies
CAR T-cell therapies are one-time treatments individually made starting from a patient’s own T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR).
During this process, a viral vector is used to encode the CAR in the patient’s T-cells so the engineered T-cells can recognize and attack the patient’s cancer cells in certain types of blood cancers. Once an individual 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.
The Oceanside site is part of Kite’s global commercial manufacturing network that includes facilities in El Segundo, California; Amsterdam, The Netherlands; and a recently FDA-approved Maryland site.
The company notes that this forms the largest dedicated in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.
Kite says it has been driven to continue expanding manufacturing network capacity due to increasing demand, consequently ensuring scheduling availability to meet the needs of physicians and their patients.
“The cell therapy manufacturing process is complex and requires specific materials, including viral vectors that play a critical role in ‘engineering’ a patient’s own T-cells to recognize and attack their cancer," said Chris McDonald, Global Head of Technical Operations, Kite.
"The certainty of timely and dependable viral vector production supplied by our own facility provides an additional level of control essential for reliably delivering CAR T-cell therapy on a large commercial scale as well as providing supply for clinical trials to develop future treatments.”