Argos looks to disposables for manufacturing personalized immunotherapies
The potential treatment, known as AGS-003, is currently being tested in a Phase III clinical trial for metastatic renal cell carcinoma (mRCC).
Jeff Abbey, president and CEO of Argos, told BioPharma-Reporter.com, “These are custom disposables for use in our closed-system, automated manufacturing processes which will produce fully personalized immunotherapies based on our Arcelis technology platform. These disposables have been developed for specific use in our process and will be fully validated for use with patient materials. A set of more than five disposables will be used for each patient.”
The company plans to utilize the disposables with its automated production technology, which captures mutated and variant antigens that are specific to each patient´s disease. The technology is designed to overcome tumor and disease induced immunosuppression in cancer and HIV, by eliciting a durable memory T cell response, without adjuvants that may be associated with toxicity.
Abbey says the system will allow the company to process biomaterials from multiple patients simultaneously in the same automated manufacturing suite.
“Our closed-system, automated manufacturing processes will allow us to produce patient-specific immunotherapies in a cost-effective and scalable manner,” Abbey told us. “On a per dose basis, we anticipate that our cost of goods will be similar to an off-the-shelf biologic. By using customized disposables for each patient, we can use the same automated manufacturing devices continuously for successive patients with minimal cleaning between each patient production run.”
The 100,000 square-foot North Carolina-based biomanufacturing facility that will produce the immunotherapies is expected to create more than 230 jobs.
The company previously 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,” Randal Goller, Director of Facilities at Argos, previously told us. “The automated cGMP manufacturing facility will house approximately 40,000 square feet of cleanrooms.”
Steve Maddox, General Manager of Saint-Gobain Performance Plastics’ Life Sciences business unit, added: “We are excited about the opportunity to partner with the Argos team to develop and supply the essential range of disposables that will be required to advance AGS-003 through late stage development and on to commercialization.”
