Amid disruption to the outsourced fill/finish market, PCI is investing $100 million to more than double the capacity to fill ready-to-use prefilled syringes and cartridges at its San Diego campus.
PCI Pharma Services is adding sterile fill/finish and drug-device delivery combination capabilities to U.S. sites as part of a $1 billion global expansion program.
The privately owned contract development and manufacturing organization (CDMO) is investing $100 million in its San Diego campus. PCI is adding a high-speed isolator filling line that will more than double the site’s capacity to fill ready-to-use prefilled syringes and cartridges. The company expects the line to be operational in the first half of 2028.
PCI currently makes more than 45 FDA-approved products at the San Diego facility, one of nine locations it has in the U.S. The company also works out of six locations in Europe and one site in Australia.
In recent years, biotechs including Horizon Therapeutics and Zogenix, which were respectively acquired by Amgen and UCB, have outsourced work to PCI sites. Other known PCI customers include Amylyx Pharmaceuticals and Revance Therapeutics.
PCI plans to open a GMP-ready bespoke isolator vial and lyophilization line at its site in Bedford, New Hampshire, this month. The company designed the line to produce batch sizes of up to 300,000 vials at 400 units per minute for a total of 33 million vials a year. A customer-dedicated, highly potent sterile fill/finish line is also on PCI’s roadmap for the site.
The company has invested in automated visual inspection capabilities at its Bedford and San Diego sites. The infrastructure supports more than 70 million prefilled syringes and cartridges and 40 million vials per year, PCI said.
PCI’s investments follow upheaval in the broader outsourced fill/finish market. In 2024, Novo Nordisk acquired three fill/finish sites previously run by the CDMO Catalent, positioning the Danish drugmaker to use the capacity for its own products rather than provide contract services to other drugmakers.
Disruption occurred when quality problems at one of the acquired fill/finish facilities led the FDA to reject applications for approval of products made at the plant and to issue a warning letter. Problems with the visual inspection program were among the compliance failings described in the warning letter.
PCI spun out of Catalent back in 2012. Frazier Healthcare created the company by acquiring two U.S. commercial pharmaceutical packaging operations from Catalent. New investors bought into PCI in 2016 and 2020, leading to last year’s investment by Bain Capital, Kohlberg and Mubadala. The recent investment, which reportedly valued PCI at $10 billion, was intended to support fill/finish and U.S. expansions.
The CDMO’s U.S. expansion program includes the addition of autoinjector and drug-device combination assembly infrastructure at sites in Philadelphia and Rockford, Illinois. PCI expects to bring the capacity online in a phased approach over the next six months and add a third autoinjector line in 2027 to grow its U.S. autoinjector and device assembly capacity to more than 250 million units per year.
