Packaging Coordinators, Inc.

PCI Pharma Services (PCI) a global contract development and manufacturing organisation (CDMO) focused on biopharma’s most complex therapies – is collaborating with theranostics specialist ChiRhoClin to avoid the potential shortage of a critical diagnostic drug used to test for pancreatic disease and cancer. Following a high-priority project executed along a tight timeline, an ample, stable supply of ChiRhoStim (Human Secretin for Injection) continues to be available to benefit patients throughout the United States. ChiRhoClin is a theranostics company specialising in orphan drugs for the gastrointestinal and radiological fields. Its intravenous product, ChiRhoStim, is essential for diagnosing pancreatic cancer and exocrine dysfunction. ChiRhoStim also supports pancreatic function testing, assists with endoscopic retrograde cholangiopancreatography (ERCP) cannulation, enables gastrinoma testing, and aids in collecting pancreatic fluid for diagnostic purposes. With ChiRhoStim experiencing unusually high demand, ChiRhoClin worked closely with the FDA CDER Drug Shortage Team to secure approval for the commercial release of the first process performance qualification (PPQ) batch. This batch was manufactured at PCI’s Bedford, NH facility and packaged at its Philadelphia site. Although the commercialisation process typically requires three PPQ runs following CDMO tech transfer, interim approval was granted due to the drug’s established commercial status at PCI. PCI’s ability to serve as a turnkey production partner helped further expedite the process. The CDMO is performing sterile drug manufacturing, lyophilisation, final testing and quality assurance release at its Bedford campus, then handling commercial labelling, packaging and distribution operations from its commercial packaging site in Philadelphia. This streamlined, “under one corporate roof” process expedited drug product release and shortened the batch’s time to market by approximately three months. Considering the time-sensitive project’s success, ChiRhoClin plans to utilise PCI as its primary manufacturing and commercial supply partner for ChiRhoStim moving forward. “Our partnership with PCI has been invaluable, and we extend our deepest gratitude for their efforts in making ChiRhoStim a priority,” said Skip Purich, CEO of ChiRhoClin “Thanks to their dedication, the pancreatic community can avoid the hardship of facing a shortage of this critical, life-saving diagnostic drug.” “For the PCI team, it is a true point of pride to assist with mission-critical, time-sensitive projects such as this – ones that lean upon our strengths as a flexible, turnkey partner capable of combining precision, quality and speed to market,” said Shawn Cain, SVP development and manufacturing and general manager, Bedford Campus. “We thank the ChiRhoClin team for their commitment to life-saving orphan drugs, and for their faith in PCI as we continue to expand our working relationship.”

PCI Pharma Services is investing over $365 million in facilities across the U.S. and Europe to support clinical and commercial-scale assembly and packaging of drug-device combination products with a key focus on injectable formats. In the U.S., PCI is expanding its Rockford, Illinois, campus with a 545,000-square-foot facility for drug-device assembly, packaging, and cold chain storage. This will include high-speed technologies for injectables and other advanced drug delivery products, with completion expected by Q3 2025. Across the Atlantic, PCI is boosting its presence in Ireland with a new packaging and assembly facility near Dublin, alongside another expansion at its CityNorth Dublin campus. These operations will enhance the company's capacity for injectables and oral solid dose products, with cold chain storage and other advanced features.

New investments will support both clinical and commercial assembly and packaging of advanced drug-device combination products, PCI Pharma Services said, placing a particular emphasis on injectables such as prefilled syringes, autoinjectors and on-body injectors. Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic.PCI has “heavily invested” in new drug delivery tech at its Philadelphia headquarters, laid plans for a 545,000-square-foot expansion in Rockford, Illinois, acquired a new packaging and device assembly plant near Dublin and broken ground on another site at its CityNorth Dublin campus.Altogether, PCI’s myriad manufacturing projects represent an investment of more than $365 million, the company said in a press release Tuesday.The cash infusion will support both clinical and commercial assembly and packaging of advanced drug-device combination products, PCI said, placing a particular emphasis on injectables such as prefilled syringes, autoinjectors and on-body injectors.The investment has been “anchored and funded” by recent new business and should help PCI capitalize on continued growth opportunities, the company added.The Rockford expansion represents the crown jewel in PCI’s expansion plan.The project will consist of 345,000 square feet of new space for advanced drug delivery injectable packaging and 130,000 square feet of extra warehouse space for products across all development phases.The site will house more than 20 customer suites and come equipped with scalable technology for assembly and packaging of vials, prefilled syringes, autoinjectors and pen-cartridge combinations, PCI said. The company is also carving out another 70,000 square feet at the Rockford site for packaging of more advanced and “patient-centric” drug-device combos, which will include on-body injectors.PCI expects the Rockford expansion to come online in two phases, with operations poised to kick off there during next year’s third quarter.Over in Ireland, meanwhile, PCI has acquired another packaging and assembly plant near Dublin that features large-scale, temperature-controlled storage capabilities. Operations there are expected to start in the coming months, PCI said. Aside from injectables, the facility will also perform commercial-scale packaging and assembly for oral solids.PCI has separately started construction on another new assembly facility at its existing CityNorth Dublin campus. The plant, expected to commence operations in 2025’s third quarter, will also emphasize injectables as well as cold chain packaging for biologics. PCI has a large manufacturing presence across multiple continents and countries with sites in Australia, Canada, the U.S., the U.K. and Europe.The company has also been investing heavily in its operations in recent years.Last spring, the CDMO unveiled plans for a $50 million expansion at the same Rockford site now slated for another upgrade. That investment went toward a new 200,000-square-foot facility to boost the plant’s capacity for injectable drug-device combination products.Prior to that move, PCI laid out $100 million in 2022 to boost aseptic liquid fill-finish production at its Bedford, New Hampshire, facility.