Global biopharma contract development and manufacturing organisation (CDMO) PCI Pharma Services has completed the acquisition of Ajinomoto Althea.
Together with the US-based sterile fill-finish CDMO, PCI Pharma Services will form a large-scale manufacturing hub in San Diego, complete with large-scale aseptic facilities for prefilled syringes and cartridges.
Althea’s campus also specialises in the development and manufacturing of customised, scalable oligonucleotides and peptides.
This will support PCI's existing manufacturing capabilities, which include the production of complex formulation and lyophilisation for injectables — including nanoparticles, mRNA, mAbs, proteins and other biologics.
The acquisition also adds high potent vial filling with lyophilisation, expanding PCI’s sterile fill- finish capacity and allowing the company to enter into the antibody-drug conjugate (ADC) niche.
This strategic move makes PCI one of the few US-based CDMOs capable of filling ADCs, adding a new development lab for potent and non-potent compounds to its Manufacturing Centre of Excellence in Bedford, New Hampshire.
US sterile fill-finish expansion
Bedford sterile fill-finish expansion strategy started with a large investment in a purpose-built facility featuring twin lyophilisers and a state-of-the-art large-scale isolator filling line compliant with Annex 1 — which will be GMP-ready this summer.
Since the plant's construction in 2022, PCI has developed aseptic-by-design processes for high-volume vial filling and lyophilisation, making the acquisition the "natural next step" in PCI's move into advanced drug delivery systems.
Last year, PCI invested more than $365m into the clinical and commercial-scale final assembly and packaging of drug-device combination products, with an emphasis on injectables.
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 commercialisation.
PCI is also investing into two large-scale facilities at its Rockford, Illinois campus, which will house more than 25 dedicated suites for the clinical and commercial-scale assembly and packaging of prefilled syringes, autoinjectors, vials and pen-cartridge combinations.
The campus will also be capable of low to medium-volume DDC assembly and packaging, which will be GMP-ready by Autumn of 2025.
European expansions
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.
Meanwhile, at its City North, Dublin campus, PCI has expanded its 120,000 sqft packaging and device assembly services facility, which will likely be operational by 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, isolator-equipped filling line for syringes and cartridges.
Through these global expansion efforts and the acquisition of Ajinomoto Althea, PCI aims to be one of the first CDMOs to bring the whole lifespan of advanced drug delivery and drug-device combination products under one roof.
“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,” he concluded.
