Why Robotic Sterile Fill-Finish Is Key For Speed To Clinic And Patient Safety

By Mark Shepanski, VP, Global Program Management, PCI Pharma Services

Sterile fill-finish is a mainstay in pharmaceutical manufacturing and robotic platforms will be a true differentiator.

The dramatic growth in the development and manufacturing of personalized therapies including biologics, cell and gene therapies and those designed to treat rare diseases, is changing the way treatments are manufactured. There is a focus on more patient-centric delivery forms such as pre-filled syringes and auto injectors as well as the more traditional vials. Greater product complexity and the need to ensure patient safety have led the FDA to advocate for less human intervention in sterile processing. As a result, the industry is looking for advanced ways to improve efficiency, reduce cost and increase sterility assurance. Robotic aseptic fill-finish technology is emerging as key to keeping pace with these developments.

Aseptic fill-finish aims to eliminate and control sources of contamination, particularly those potentially generated by humans, to ensure sterility and patient safety. The process achieves this goal via a fully automated gloveless GMP filling process and the use of ready-to-use (RTU) components, thus removing operator intervention and delivering batch manufacture within contained sterile isolator technologies. Robotic technology and the use of “isolator-barrier systems” are the core technologies that are advancing sterile fill-finish delivering product purity assurance.