Automated closed systemdevice
Argos has made extensive progress in automating a closed, GMP- compliant system for DC manufacturing. This system involves a computer-controlled workstation that links a GAMBRO Elutra device (to harvest monocytes from pheresis products) to closed-system cell culture process. All media changes and washes are automated and limited operator intervention is required throughout the entire process. A second computer-controlled work station harvests the matured DC, electroporates them with RNA, and aliquots, vials, and freezes individual vaccine doses. Argos has consulted with the U.S. FDA on the design of the automated DC platform and received a favourable review. Two apha units of each workstation have been built and the various sub-systems are undergoing additional testing and validation at Argos.