PCI Pharma expands global sterile fill-finish capacity
PCI Pharma, a contract development and manufacturing organization (CDMO), announced that the machinery will be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs.
According to the company, when paired with PCI’s end-to-end services, the automated equipment will decrease the average turnaround time from proposal signing to the injectable product’s distribution.
In terms of the equipment added, a microcell vial filler and a SA25 aseptic filling workcell are now operational in PCI’s San Diego, US, facility. An additional microcell vial filler was also installed at the company’s Melbourne, Australia, site. The equipment in the US will be used to deliver medicines from Phase I to Phase III, while the Australian location focuses on providing Phase I services.
PCI stated that the automated nature of the equipment removes the need for human intervention in a sterile environment, which creates compliance advantages over standard equipment.
Brad Payne, CCO of PCI Pharma Services, said, “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.”
PCI purchased the equipment from Cytiva, in a move that was announced in March 2022. According to Cytiva, the microcell vial filler is a closed robotic isolator for vial filling, which enables small batch flexibility and standardized manufacturing.
The machinery can fill up to four different products in an eight-hour shift, and also employs single-use consumables to reduce fill times.
The SA25 aseptic filling workcell is able to fill vials, syringes, and cartridges with an aseptic process. The equipment can fill any of these formats from 0.2ml to 50ml, and has the ability to change between formats in 45 minutes.
Olivier Loeillot, VP and general manager, BioProcess, Cytiva, provided further information on the capabilities of the equipment: “PCI's expansion of its filling capacity shows the power a standardized, robotic filling platform can offer customers. They’ll appreciate the lower risk of the Workcells’ closed, robotic, and repeatable aseptic process.”
Last year, Cytiva announced that it would expand its capacity for aseptic filling machinery based on the demand it was seeing for its products.