Dual-chamber systems provide an option as a drug and device combination product, when home care and emergency lyophilized products are intended. Nevertheless, until today, there are only a few products on the market, due to the challenges and limitations in manufacturability, product formulation, and product stability in a dual-chamber configuration, as well as economic considerations. This review serves to describe currently available dual-chamber systems and to discuss factors to be considered for appropriate selection and establishing fill-finish processes.
Keywords: aseptic processing; biologics; biopharmaceutical; dual-chamber cartridge; dual-chamber syringe; dual-chamber systems; fixed dose combination; freeze-drying; home care; small volume parenterals.
Copyright © 2016. Published by Elsevier Inc.