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A major problem in personalized medicine has been scale-up.
A major problem in personalized medicine has been scale-up. This was the question faced by the researchers at Argos Therapeutics (Research Triangle, NC). Argos’s renal cell carcinoma and HIV drugs are currently in Phase 2, but if they reach Phase 3, or commercial approval, Argos will need a way to scale-up and speed up the manual manufacturing process which currently takes six weeks, from receipt of the materials to delivery to the patients.
To solve these problems, Argos used a combination of automation and disposables. They developed a new disposable hood, in-house, which can hold all the reagents necessary for the RNA step of the manufacturing process of the therapeutics. The self-contained hood is accessible by a robotic arm that performs all of the processes inside the custom hood and is discarded after each use.
The hood, which has been in development since 2004, was developed in conjunction with Australian-based Invetec, and financed by Argos’s partner Kirin Pharma (La Jolla, CA). With the new system in place, Argos has been able to bring the process time down to 4–5 weeks.
Although the hood is not yet being used for manufacturing any of the drugs in clinical trials, according to Frederick Miesowicz, PhD, chief operating officer at Argos, the company expects the device to be operational for a Phase 3 study in 2011. Until then, they are continuing testing and validation of the disposable, because it must be validated according to cGMPs.