Gilead Sciences subsidiary Kite Pharma announced plans to build a new viral vector manufacturing facility in Oceanside, California, US, in July 2019.
The new facility was approved by the US Food and Drug Administration (FDA) for commercial production in October 2022. It is used for manufacturing viral vectors to produce cell therapy, as well as the company鈥檚 first commercially available chimeric antigen receptor T (CAR T) cell therapy known as Yescarta庐.
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The new facility improves the development, manufacturing, and supply capabilities of Kite Pharma鈥檚 CAR T-cell therapies and future pipeline products. It is an addition to Gilead鈥檚 existing network of manufacturing sites in California and Maryland, US, and the Netherlands.
Location of the viral vector manufacturing facility
The viral vector manufacturing facility is located within Gilead鈥檚 existing biologics operation facility at 4049 Avenida de la Plata, Oceanside. The facility was purchased from Genentech in August 2011.
Situated between Los Angeles and San Diego, Oceanside is connected to Los Angeles by Interstate I-405 South and to San Diego by Interstate I-5 North. Oceanside can be accessed through three highways, I-5, Highway 78, and Highway 76.
In March 2022, Gilead purchased approximately 27 acres of land in Oceanside, next to the existing facility to support future manufacturing operations.
Kite Pharma鈥檚 viral vector manufacturing facility details
The state-of-the-art viral vector manufacturing facility is a 100,000ft虏 building focused on the development and production of viral vectors in-house for pre-clinical or early-stage clinical trials, as well as commercial use.
The facility is staffed by a team of experts and operates under stringent regulatory guidelines to ensure that the finished products are safe, pure, and effective.
The new facility is dedicated to the manufacture of viral vectors such as replication-deficient gamma-retroviral vector PG13-CD19-H3 and replication-deficient lentiviral vector.
PG13-CD19-H3 is the important starting material used to produce Yescarta. It was the company鈥檚 first CAR T-cell therapy that was approved by the FDA in 2017 and is used for the treatment of large B-cell lymphoma in adult patients.
Yescarta is developed from the patient鈥檚 own white blood cells (WBCs). T-cells from the WBCs are extracted, modified and re-infused into the patients to identify and kill cancer cells.
The retroviral vector PG13-CD19-H3 is also used for the development of other investigational therapy candidates such as KTE-X19 for acute lymphocytic leukaemia and mantle cell lymphoma.
The facility develops a replication-deficient lentiviral vector, which is used to produce an investigational biologic candidate KITE-585. It also supports the production of KITE-718 therapy.
Kite Pharma鈥檚 cell therapy technology
Kite Pharma develops T-cell-based cancer immunotherapies for oncology by using a chimeric antigen receptor (CAR) or a T-cell receptor (TCR), based on the type of cancer. CAR T-cell therapies are one-time treatments produced from a patient鈥檚 white blood cells or T-cells.
CARs are engineered proteins that contain an antibody or target-binding component to identify the specific antigen expressed by the tumour cells and other signal-activating components for T-cells to kill tumour cells.
TCRs are specifically modified proteins for a particular type of cancer, which enables T-cells to recognise and kill antigens expressed by the tumour cells.
The manufacturing of CAR T-cell therapies involves the removal of T-cells from a patient鈥檚 blood. A viral vector is then used to encode a CAR in the T-cells to enable them to recognise and attack cancer cells in the patient.
More than 10,000 patients have been treated with Kite鈥檚 CAR T-cell therapies worldwide.
Marketing commentary on Kite Pharma
Based in Santa Monica, California, US, Kite Pharma is a pharmaceutical company focused on the development and manufacture of immune-based cell therapies for cancer treatment, with its manufacturing operations in North America and Europe.
Biotechnology company Gilead Sciences acquired Kite Pharma for $11.9bn in October 2017. More than 700 Kite employees became part of Gilead鈥檚 portfolio following the acquisition.
Kite Pharma鈥檚 clinical and commercial manufacturing facilities are in Foster City, San Dimas, La Verne, El Segundo, and Oceanside in California; Cork, Ireland; and Edmonton, Canada.
The company contracts with third-party manufacturers for certain active pharmaceutical ingredients (APIs) and commercial products.
