Prefilled dual chamber devices (DCDs) – Promising high-quality and convenient drug delivery system

[Display omitted] •Prefilled dual chamber devices (DCDs) as emerging drug delivery system for biopharmaceuticals.•Composition and manufacturing challenges for prefilled DCDs.•Current global market scenario for prefilled DCDs.•ISO standards and CCI quality requirements for prefilled DCDs.•Role of extractables and leachables on the quality of prefilled DCDs. Prefilled dual chamber devices (DCDs) are combination products containing freeze-dried drug and diluent in two separate chambers of the device. DCDs provide high stability and convenience to patients and doctors, thus significantly improving product quality, patient compliance and market competitiveness. DCDs should also provide seal integrity, sterility and compatibility with biopharmaceuticals and avoid leachability and needle stick injuries. DCDs are promising alternatives to traditional containers or devices for biopharmaceuticals. The regulatory and medical practice to choose plastic DCDs as better alternatives over well-established glass syringes will be addressed here. The impact and major issues during processing, manufacturing, and storage of DCDs are also highlighted. Further discussion clears its business potential, composition, stability testing, and quality standard requirements to deal with market competition. It also covers major role of extractables and leachables in storage stability of the product.