Viral vector manufacturing facility
Kite Pharma, a subsidiary of Gilead Company, announced plans to build a new viral vector manufacturing facility in Oceanside, California, US, in July 2019.
The facility will be used for manufacturing viral vectors for production of cell therapy as well as the company’s first commercially available chimeric antigen receptor T (CAR T) cell therapy known as Yescarta®.
The new facility will improve development, manufacturing, and supply capabilities of the existing CAR T-cell therapies and future pipeline products.
The viral vector manufacturing facility will be developed within Gilead’s existing biologics operation facility in 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.
A new state-of-the-art 67,000ft² building will be constructed inside Gilead’s existing facility.
The new facility will be 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 for production of Yescarta. It was the company’s first CAR T-cell therapy that was approved by the US Food and Drug Administration (FDA) in 2017 and is used for treatment of large B-cell lymphoma in adult patients.
Yescarta is developed from patient’s 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 development of other investigational therapies candidates such as KTE-X19 for acute lymphocytic leukaemia and mantle cell lymphoma.
The facility will develop replication-deficient lentiviral vector, which is used to produce an investigational biologic candidate KITE-585. It will also support production of KITE-718 therapy.
It will be an addition to Gilead’s existing network of manufacturing sites in California, Maryland and the Netherlands in Europe.
Gilead’s existing facility in Oceanside is a 70,000ft² building with the related process development resources.
The facility was designed and equipped for production of biologics candidates. It is currently used for clinical manufacturing and process development of biologic compounds for pre-clinical or early-stage clinical trials.
Kite Pharma develops T-cell-based cancer immunotherapies for oncology by using CAR or a T-cell receptor (TCR), based on the type of cancer.
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 component 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.
Based in California, US, Kite Pharma is a pharmaceutical company focused on development and manufacture of immune-based cell therapies for cancer treatment.
US-based biotechnology company Gilead Sciences acquired Kite Pharma for $11.9bn in October 2017.
Kite’s CAR and TCR platforms and more than 700 employees of Kite became part of Gilead’s portfolio following the acquisition.
The company’s clinical and commercial manufacturing facilities are located in Foster City, San Dimas, La Verne, El Segundo, and Oceanside in California (US), Cork in Ireland and Edmonton in Canada.
The company contracts with third-party manufacturers for certain active pharmaceutical ingredients (APIs) and commercial products.
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