The facility is expected to create more than 230 jobs and will include proprietary equipment for the automated manufacturing of products via its Arcelis platform. AGS-003, the company's lead oncology product candidate, is currently being evaluated in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma.
Randal Goller, Director of Facilities at Argos, told BioPharma-Reporter.com, “The Arcelis technology platform can be leveraged to manufacture personalized therapies for any cancer or infectious disease and integrates readily into current treatment paradigms.
“The proprietary technology uses RNA isolated from a patient disease sample to program dendritic cells, derived from the patient’s white blood cells, to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered as an injection into the skin to produce the desired patient-specific immune response.”
The company said that this one facility could serve all of its expected patients in North America, and that because it’s automated, the company “avoids ramp up problems experienced by Denderon.”
And what’s unique about the manufacturing process is that it “does not require any bioreactors or any type of large stainless steel vessels,” Goller said. “The automated cGMP manufacturing facility will house approximately 40,000 square feet of cleanrooms.”
Argos received approximately $9.5m in incentives to build the facility from the State of North Carolina, Durham County, thecity of Durham, and the North Carolina Biotechnology Center, for the development and implementation of the facility, which will support automated production of the company's Arcelis-based personalized immunotherapy product candidates for the treatment of cancer and infectious diseases.
As far as how the company plans to manage all of its new space, Goller told us that no contract manufacturing is anticipated at this time. The facility “will be a flexible modular design (multi-product/multi-function) to support manufacturing for 2,500 patients per year at commercial launch and scalable to 10,000 patients per year.”
“The Arcelis technology platform overcomes many of the manufacturing and commercialization challenges that have impeded other cancer immunotherapies,” he continued. “Automated processes will allow a single commercial facility to serve all of North America at a significantly reduced cost of goods and can be used to treat any cancer with the same manufacturing process and equipment.”
The Keith Corporation of Charlotte, N.C., will construct the facility.