PCI Pharma initiates installation of $100M isolator-based sterile fill-finish site
The ongoing construction and validation activities mark a significant step in the company's ambitious $100 million capital investment project, tipped for completion later this year, with full-scale production set to commence in early 2025.
The new 50,000-square-foot facility will feature twin lyophilizers and a state-of-the-art large-scale isolator filling line, forming the backbone of PCI's commitment to enhancing its sterile fill-finish capacity and production capabilities.
The company says it is excited to witness the progress of its newest facility, which it says highlights its dedication to meeting the evolving needs of clients and the industry.
This development marks the culmination of PCI's strategic vision to establish high-throughput, isolator-based sterile fill-finish facilities, aligning perfectly with the organization's mission to deliver cutting-edge solutions to its global clientele. With meticulous attention to detail since its groundbreaking in 2022, PCI has been steadfast in developing aseptic-by-design processes to ensure the highest standards of product integrity and safety.
The forthcoming facility will boast Annex 1-compliant technology, including a fully isolated containment system and twin 430-square-foot lyophilizers equipped with advanced loading and unloading systems. Capable of handling batch sizes of up to 300,000 vials at a remarkable rate of 400 vials per minute, the integrated filler is primed to cater to the production needs of a diverse range of life-changing pharmaceuticals, from late-phase clinical to commercial small molecules and biologics.
Engineering and validation runs are slated for the late fall, paving the way for GMP production by Q1 2025. In a proactive move to engage with both existing and prospective clients, PCI will be extending invitations for plant visits starting this summer, offering a firsthand look at the facility and the opportunity to secure production capacity.
With over two decades of expertise in lyophilization and sterile fill-finish manufacturing, PCI is poised to elevate its capabilities with the addition of this high-volume facility.
“Our relentless pursuit of excellence, coupled with our seasoned teams and robust partnerships, positions us to deliver on the most challenging of projects,” says John Ross, senior vice president of drug development and manufacturing at PCI Pharma Services.
“The forthcoming facility stands as a testament to our unwavering commitment to advancing healthcare through innovation and collaboration.”
PCI Pharma Services, a world-leading Contract Development and Manufacturing Organization (CDMO) offers integrated end-to-end drug development, manufacturing, and packaging solutions, facilitating clients' product speed to market and commercial success. With more than 90 successful product launches annually and more than five decades of experience in healthcare services, PCI operates 30 sites across seven countries, employing over 6,000 professionals dedicated to delivering life-changing therapies to patients. Using leading-edge technology and ongoing investments, PCI addresses global drug development needs across the entire product life cycle, serving as a collaborative partner to improve patients' lives.
