The move follows PCI’s recent acquisition of Lyophilization Services of New England (LSNE), which manufactures complex injectables
One Microcell Vial Filler was placed in PCI’s Melbourne facility. (Credit: Business Wire.)
PCI Pharma Services, a US-based contract development and manufacturing organisation (CDMO), has unveiled its plans to add three new automated sterile fill-finish machines at its facilities in San Diego, US, and Melbourne, Australia.
The contract manufacturer bought the new machinery that can pivot between filling sterile medications into vials and syringes from Cytiva, previously GE Healthcare Life Sciences.
The move follows PCI’s recent acquisition of Lyophilization Services of New England (LSNE), which is specialised in the manufacturing of complex injectables.
According to PCI, LSNE has widened its capabilities across the entire product lifecycle and allowed it to bring life-changing therapies to market rapidly and safely.
PCI Pharma Services chief commercial officer Tim Roberts said: “The addition of this cutting-edge equipment in two key locations, San Diego and Melbourne, is part of our global strategy to increase our sterile fill-finish capabilities and help alleviate the worldwide capacity shortage for sterile drugs manufacturing and packaging.
“The increase in the number of novel drug products in development across several therapeutic areas, combined with high demand to produce Covid-19 vaccines, has made it more and more difficult for pharmaceutical companies to partner with trusted CDMOs with expertise and capacity to meet their drug product manufacturing needs.
“The Cytiva technology will allow PCI to offer our clients additional sterile fill-finish capabilities to support their clinical development and manufacturing and ultimately bringing important therapies to market faster across the globe.”
PCI installed a Microcell Vial Filler and SA25 Aseptic Filling Workcell at its San Diego facility, which supports the delivery of medicines from Phase 1 through Phase 3.
It has already placed a Microcell Vial Filler at its Melbourne facility to enhance the early-stage services and bring additional capacity to Australia.
Contained inside an isolator, the new units are said to enhance patient safety and compliance advantage over the company’s competitors, using hand filling technology.
The company said that the advanced machinery would advance the filling process with automation and eliminate the need for human intervention in a sterile environment.
The new machines are expected to be fully operational by September this year.
According to PCI, the investment will enhance LSNE’s offerings, including complex formulations, high potency, sterile fill-finish, and lyophilisation.
PCI Pharma Services chief operating officer Brad Payne said: “Our Melbourne and San Diego facilities are located where a high volume of early phase clinical trials are taking place and key biopharmaceutical organisations are located.
“This expansion is part of our plan to better serve our clients by adding capabilities which complement our integrated offerings in clinical trial services such as packaging and S&D that create ease and simplicity in key business hubs.
“The integration of this leading-edge equipment into important global sites will create even more efficient biopharmaceutical supply chains for PCI and its clients, leveraging new technologies so we can continue bringing necessary drugs to patients faster, together with our clients.”