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The process of developing novel cancer therapies is complex. As a result, the industry is seeing a growth in in-house manufacturing for companies with a focus on cancer treatments. Companies need to move fast and efficiently, as they are facing fierce competition.

Companies in the Spotlight

Kite Pharma recently opened a new CAR-T cell manufacturing plant that brought about a great advance in cancer therapy production with its prime location for optimal distribution. Located next to the Los Angeles airport, the site has the ability to settle the urgency of receiving and delivering individualized treated T cells to patients. In the company’s announcement of the new facility, Kite Pharma stated that the plant’s location was chosen with the intention to “expedite receipt and shipment of engineered T cells from and to patients across the United States and Europe.” The corporate announcement explained that its new process as “one of the fastest in the industry,” with it taking only 14 days for the company to receive the materials and deliver the engineered T cells to the patient. Although the facility’s initial products will be produced for clinical trials, Kite is looking to get its lead candidate first-to-market. Earlier this week, Kite announced its completed enrollment of 72 patients for the Phase II portion of its ZUMA-1 trial in blood cancer patients. The company is aiming to have its leading CAR-T product, KTE-C19, approved and launched by 2017.

Novartis’ recently acquired plant, formerly Dendreon, is making groundbreaking progress in clinical trials with their novel cancer therapy known as CTL019. Novartis, the first of the two recognized field leaders, calls its individualized drug “potentially curative” since it has resulted in leaving 92% of patients cancer-free during early trials. The company expects to file for FDA approval sometime this year.

Celgene is currently investing in Juno Therapeutics, the second of the two recognized field leaders, for its development of new CAR-T cancer therapies. Following a recent suspension of its clinical trial on patients with relapsed or refractory B cell acute lymphoblastic leukemia, the FDA has lifted the clinical hold on Juno’s lead candidate, JCAR015. The company will proceed with testing the immunotherapy with a revised treatment protocol which avoids the use of the chemotherapy agent, fludarabine. Although the hold may have not significantly delayed the clinical development of the therapy, it still remains unclear as to what effect this may have on Juno’s planned time to file for FDA approval of the drug.

Blue Mountain Quality Resources appreciates the efforts and dedication of all companies in the cancer therapy field. We understand that the race to manufacturing these therapies is at full speed and we are committed to helping these organizations bring safe and effective products to market in order to better the quality of life for patients around the world.

Additional Sources:

http://www.fiercepharma.com/manufacturing/kite-pharma-opens-car-t-cell-manufacturing-next-to-la-airport

http://www.fiercepharma.com/manufacturing/novartis-others-face-higher-manufacturing-costs-car-t-cell-treatments

http://www.fiercebiotech.com/partnering/updated-celgene-pays-1b-landmark-deal-to-buy-into-juno-s-pipeline-of-car-t-drugs

http://ir.kitepharma.com/releasedetail.cfm?ReleaseID=976420

http://www.biopharmadive.com/news/hours-after-juno-tragedy-kite-announces-full-enrollment-in-car-t-trial/422385/

http://www.fiercebiotech.com/biotech/hours-after-juno-s-car-t-study-deaths-announced-kite-starts-new-car-t-phii

http://www.biopharmadive.com/news/juno-FDA-clinical-hold-lift-car-t/422483/