The 43,500 sq ft plant in El Segundo, California officially opened its doors last week, ahead of the US approval and launch of Kite Pharma’s lead candidate, KTE-C19, anticipated by the firm next year.
The product is intended to treat chemorefractory diffuse large B-cell lymphoma (DLBCL) and is an autologous chimeric antigen receptor (CAR) T-cell therapy, meaning it is made using a patient’s own modified cells, as Kite’s EVP of technical operations Timothy Moore explained.
“[Our] therapies involve a process of extracting cells from a cancer patient and air shipping them to our El Segundo facility,” he told Biopharma-Reporter.com. “In a six to eight day process utilising Kite’s proprietary genetic engineering technology, the cells are re-engineered to seek and selectively destroy cancer cells while leaving normal cells unharmed.”
The modified cells are then frozen and shipped back to the patient, Moore continued, where they are re-infused into the patient. “The entire vein-to-vein process takes about 14 days, one of the fastest in the industry.”
Time is critical for patients who receive CAR T therapies, and this was a factor in the location of the new facility.
“Our facility’s location, next to Los Angeles International Airport, one of the largest and busiest airports in North America, is ideal for expediting the shipment of CAR T therapies.”
Production
As for the manufacturing process, Moore said the El Segundo site will have the capacity to produce up to 4,000-5,000 patient therapies per year using semi-automated equipment source from multiple suppliers.
“The facility is equipped with technology that separates, washes, expands and genetically modifies cells to meet the necessary potency and dose for patients.”
The site will also produce clinical trial material for Kite’s other CAR and T-cell receptor (TCR) candidates, complementing Kite’s existing clinical manufacturing facilities in Santa Monica. However, as the site is focused on commercial quantities, we asked how Moore how confident the firm was KTE-C19 would be approved next year.
“As reported, early results achieved with this therapy have been very encouraging. Approximately half of the treated patients achieve a complete response. Of all patients treated, the overall response rate is 70 to 80 percent. So we remain on track for FDA review in 2017.”