A lack of manufacturing bandwidth is putting the squeeze on Dendreon's newly approved immunotherapy, Provenge. The prostate cancer drug's demanding manufacturing process is so far approved in only one facility, currently operating at 25 percent capacity.
Provenge is customized to each patient, who provides antigen-presenting cells that trigger an immune response. Dendreon cultures the cells with a proprietary manufactured protein, yielding the treatment. The patient is then given the treatment, which aims to stimulate the immune response and neutralize tumor cells, according to a National Cancer Institute bulletin. Patients are given three treatments--with each requiring the same production process--over several weeks.
Dendreon projects that it can provide treatment for 2,000 patients, which it plans to find at 50 oncology and urology clinics that participated in the drug's clinical trials. Facilities in Georgia and California are in the works. The company says it expects FDA approvals by mid-2011.
- here's the article