Kite, a Gilead Company, has announced that the U.S. Food and Drug Administration (FDA) has given it the go-ahead to begin commercial production of its retroviral vector (RVV) facility in Oceanside, California.
Viral vectors are essential components required for the production of Kite’s cell therapies to treat specific blood cancers. At this time, Kite is the only pharma firm capable of producing commercial and clinical trial viral vectors in-house. This capability has enhanced its already robust relationships with external supply partners.
Chimeric antigen receptor (CAR) T-cell therapy is a technique that enables T-cells (a type of white blood cells) fight cancer. The therapy modifies these cells in such a way that they gain the ability to not just locate, but also eradicate the cancer cells.
These one-time treatments are conceived starting with the patients’ own T-cells, which are removed through a process akin to blood donation. The CAR is encoded in the patient’s T-cells using a viral vector. This allows the engineered T-cells to recognize and attack the patient’s cancer cells in certain types of blood cancers. Once a therapy is developed, the cells are carefully maintained, packed, and returned to the hospital for re-infusion. Kite’s therapies have treated more than 9,000 individuals worldwide in over 300 medical facilities – these include over 115 of the most prominent cancer facilities in the U.S.
Christi Shaw, the CEO of the company, said, “The FDA approval of our 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. 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 Oceanside facility is part of Kite’s extensive network of commercial manufacturing facilities, which also includes sites in Amsterdam, El Segundo, and Maryland. This creates the world’s biggest on-site manufacturing network for cell therapy, with capabilities that include process formulation, product production, and clinical trial development. Kite has continued to expand its manufacturing network resources in order to meet rising demand and maintain scheduling availability for patients and doctors alike.
Chris McDonald, the company’s Director of Technical Operations, stated that the cell therapy manufacturing process is far from straightforward, requiring certain complex materials – including viral vectors – that play a vital role in enabling a person’s own white blood cells to recognize and fight their cancer. As such, the company’s viral vector production is the most dependable out there, with an added level of control due to the facilities it owns. Without this level of control, it’s almost impossible to reliably deliver CAR T-cell therapy on such a massive commercial scale, he added.
Kite continues to focus on expanding its cell therapy workforce – currently, the company employs around 100 workers in the 100,000-square-foot space. Additionally, its operations and infrastructure are highly scalable, enabling it to support additional vector manufacturing as cell therapy research progresses.
