PCI Pharma Services, (“PCI”) a leading global contract development and manufacturing organization (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 the company’s 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 utilizing a variety of delivery systems and containers, including prefilled syringes, vials, and cartridges.
In addition, on Wednesday June 5, PCI is offering tours of its nearby fully robotic isolator sterile fill-finish production facility to attending media, including transportation for the half-hour drive between the San Diego Convention Center and its production plant. The site specializes 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 sterilization of the container closures, filling into the container closure system (CCS) of choice, capping, and batch delivery.
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.
For pharma brand owners, robotics-driven aseptic processing brings a variety of increasingly attractive benefits.
“Aseptic processing utilizing isolator robotics supports validated, recipe-driven systems via elements such as single-use parts, pre-sterilized flow paths, and ready-to-use containers,” said Derek Truninger, San Diego General Manager for PCI Pharma Services. “In addition to significantly minimizing 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.”
For pharma companies moving toward clinical trials, two particularly valuable benefits emerge: minimized product loss and reduced timelines. With many APIs in limited supply and of high value, robotics-enabled aseptic processing can limit losses to around 50mL for an entire batch, substantially reducing cost and increasing the number of doses available to patients. These same efficiencies, combined with integrated clinical labeling, packaging and supply chain management from a single site, lend to shorter, more straightforward clinical trial journeys.
