PCI Pharma Services, a global contract development and manufacturing organisation (CDMO), will highlight the recently incorporated robotics technology for sterile fill-finish operations at its San Diego facility at BIO 2024, June 3-6 in San Diego.
At Booth #6050, drug product development and manufacturing experts will discuss how such systems are delivering speed to clinic and capacity, with state-of-the-art sterile fill-finish operations for early phase clinical trials utilising a variety of delivery systems and containers, including prefilled syringes, vials and cartridges.
Facility tours
PCI will also offer tours of its nearby fully robotic isolator sterile fill-finish production facility to attending media on Wednesday June 5. The site specialises in end-to-end clinical solutions for clients, from sterile fill-finish and clinical packaging to storage and distribution.
For PCI, the robotics-enabled fill-finish systems support improved efficiency, substantially limiting drug product loss for clinical trial supply while enhancing quality and sterility assurance.
The precise, programmable robotic functions cover all aspects of the fill process, including isolator leakage tests, VHP sterilisation of the container closures, filling into the container closure system (CCS) of choice, capping and batch delivery.
Manufacturing solutions for all to see
At its San Diego facility, PCI’s isolator robotics technology comprises one Cytiva Microcell Vial Filler unit for earlier clinical-scale manufacturing and a larger-scale Cytiva SA25 Aseptic Filling Workstation supporting scale-up for later-phase clinical trials.
The Microcell unit offers fully automated gloveless filling performed through closed robotic isolator technology.
Superior product quality is assured through advanced automation, limiting product contact and removing the need for operator intervention during filling. The Microcell technology can fill up to 1,200 vials per batch, at fill volumes from 1-50mL.
Meanwhile, the larger-scale SA25 Aseptic Filling Workstation offers gloveless, isolator-based filling for batches up to 20,000 units at fill volumes from 0.2-50mL. The versatile system can aseptically fill multiple delivery device formats including vials, syringes and cartridges.
“Aseptic processing utilising isolator robotics supports validated, recipe-driven systems via elements such as single-use parts, pre-sterilised flow paths and ready-to-use containers,” said Derek Truninger, San Diego General Manager for PCI Pharma Services. “In addition to significantly minimising product loss, the result is risk elimination across multiple fronts, including potential cross-contamination, human error, electro-mechanical filling and closure activity failures, environmental control failures, cleaning and setup errors.”
