Viral vectors are said to be very important components required for manufacturing Kite’s cell therapies for the treatment of certain blood cancers
FDA approves start of commercial production at the new RVV facility of Kite. (Credit: PublicDomainPictures from Pixabay)
Kite, a Gilead Company, has secured consent from the US Food and Drug Administration (FDA) for starting commercial production at its retroviral vector (RVV) manufacturing facility in Oceanside, California.
According to Gilead Sciences, viral vectors are very important components required for manufacturing Kite’s cell therapies for the treatment of certain blood cancers. Gilead Sciences acquired Kite Pharma in a deal worth around $11.9bn in 2017.
The retroviral vector manufacturing facility in Oceanside is part of Kite’s global commercial manufacturing network. The other facilities include El Segundo in California, Amsterdam in the Netherlands, and the Maryland site, which was recently approved by the FDA.
Kite CEO Christi Shaw 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.”
Kite announced plans to build the new viral vector facility in Oceanside in July 2019. The facility has been built within an existing Gilead Sciences’ biologics operations facility in the Californian city.
Gilead Sciences said that its subsidiary continues to invest in its workforce for cell therapy, employing nearly 100 people in the 100,000sft space. Both the capabilities and operations are scalable fully and will enable Kite to facilitate additional vector manufacturing with the advancement in cell therapy science, said Gilead Sciences.
Kite technical operations global head Chris McDonald said: “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 recognise and attack their cancer.
“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.”