For PCI, the acquisition is a cornerstone of a multi-year investment strategy spanning facilities in the United States and Europe. In the United States, Althea’s assets combine with PCI’s existing sterile fill-finish and advanced drug delivery operations to form a world-class, large-scale manufacturing hub in San Diego, complete with state-of-the-art large-scale aseptic facilities for prefilled syringes and cartridges.
Among other categories, Althea’s campus specializes in customized, scalable oligonucleotides and peptides, supporting PCI’s existing manufacturing of complex formulations and lyophilization for a broad range of injectables – including nanoparticles, mRNA, MABs, proteins and other biologics.
The acquisition also adds high potent vial filling with lyophilization, expanding PCI’s sterile fill-finish capacity and serving as an expedient entrée into the rapidly emerging oncology modality of high potent antibody-drug conjugates (ADCs). In fact, the move places PCI among the few US-based CDMOs capable of filling ADCs – a category the company initially began building toward earlier this year, with a sophisticated new pharmaceutical development lab for potent and non-potent compounds at its manufacturing Center of Excellence in Bedford, NH.
The Bedford sterile fill-finish expansion strategy started with a large investment in a purpose-built facility featuring twin lyophilizers and a state-of-the-art large-scale isolator filling line compliant with Annex 1. That facility will be GMP ready this summer; since the plant’s 2022 groundbreaking, PCI has methodically developed aseptic-by-design processes as part of its commitment to providing fully isolated high-volume vial filling and lyophilization solutions.
Considering this, the acquisition is a natural next step in PCI’s evolution in advanced drug delivery systems like prefilled syringes, cartridges and autoinjectors. Last year, PCI announced investments exceeding $365 million to support the clinical- and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced delivery systems, with an emphasis on injectable formats. Comprising new and expanded infrastructure in both the United States and Europe, the effort bolsters PCI’s ability to manage the full lifespan of DDCs, from sterile drug product development and manufacturing through clinical trial supply, product launch and commercialization.
In the United States, the investment includes two new large-scale facilities at PCI’s Rockford, Illinois campus. Building upon the company’s successful Philadelphia Biotech Center of Excellence, the facilities will house over 25 dedicated suites with high-speed, multiformat lines for clinical- and commercial-scale assembly and packaging of prefilled syringes, autoinjectors, vials and pen-cartridge combinations, and incorporate extensive ISO-standard product testing capabilities and premium top-load cartoning technology. The campus also comprises capabilities for low- to medium-volume DDC assembly and packaging. Both facilities will be GMP ready in fall 2025.
In Europe, PCI recently acquired a packaging and device assembly facility in Dundalk, Ireland, which provides commercial-scale operations for injectables and oral solid dose products. At its City North Dublin campus, PCI also expanded and constructed a 120,000-sq-ft packaging and device assembly services facility, which is slated to commence operations in summer 2025.
Elsewhere in Europe, as part of an additional $25 million investment in its Leon, Spain facility, PCI is currently incorporating a sophisticated new high-speed filling line for syringes and cartridges. Equipped with isolator technology, the automated line delivers unsurpassed flexibility and reliability for biopharma customers. The effort also includes a recently completed state-of-the-art biologics development lab, further enhancing PCI’s upstream capabilities.
Assisted by the Althea acquisition, PCI’s goal is to be among the first CDMOs to bring the whole lifespan of advanced drug delivery and drug-device combination products under one corporate roof – a journey spanning PCI’s clinical trial supply network with cold chain storage solutions straight through launch and commercialization.
“Our pharma customers and the healthcare personnel and patients they serve are the heartbeat behind each stride we’ve made throughout this ambitious investment plan in sterile fill-finish and advanced drug delivery solutions,” said Salim Haffar, CEO of PCI Pharma Services. “Concerning this latest step, Ajinomoto Althea enjoys a longstanding, well-earned reputation for producing novel biologics in various injectable formats. Welcoming Althea’s talented professionals into the PCI family strengthens our commitment to turnkey customer partnerships and, ultimately, our dedication to helping improve patient outcomes through life-changing therapies.”
About PCI Pharma Services:
PCI is a world-leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 35 sites across seven countries (United States, Canada, United Kingdom, Ireland, Germany, Spain and Australia), and over 8,000 employees working to bring life-changing therapies to patients.
Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients’ lives.
For more information, please visit www.pci.com.
