PCI Pharma Services ("PCI") is pleased to announce the launch of Ajinomoto Althea, the world's leading contract research and manufacturing organization (CDMO) specializing in innovative biopharmaceutical therapeutics ("Altair"). Altair is a US-based aseptic filling formulation CDMO and a subsidiary of Ajinomoto Co., Ltd. in Japan. The acquisition is the cornerstone of a multi-year investment strategy for facilities in the U.S. and Europe. In the U.S., Altair's assets will be integrated with PCI's existing aseptic filling and advanced drug delivery operations, creating a large-scale, world-class manufacturing facility in San Diego with state-of-the-art large-scale aseptic facilities for prefilled syringes and cartridges. Altair's campus specializes in the production of customizable and scalable oligonucleotides and peptides, supporting PCI's existing manufacturing of complex formulations and lyophilizations for a wide range of injectables, including nanoparticles, mRNA, MAB, proteins, and other biologics.

The acquisition also adds high-activity vial filling with lyophilization, further expanding PCI's aseptic filling capabilities and serving as a rapid entry into the fast-growing oncology modality of highly active antibody-drug conjugates (ADCs). In fact, the move makes PCI one of the few U.S.-based CDMOs capable of filling ADCs. The company's foray into this space began earlier this year when it established a sophisticated new drug development lab for highly potent and non-potent compounds at its Manufacturing Center of Excellence in Bedford, New Hampshire. The aseptic filling expansion strategy in Bedford began with a major investment in a purpose-built facility with twin freeze dryers and a state-of-the-art large-scale isolator filling line compliant with Annex 1. The facility is expected to be GMP compliant this summer. Since the groundbreaking of the plant in 2022, PCI has systematically developed a sterile design process as part of its commitment to providing fully separated, high-volume vial filling and freeze-drying solutions.

Against this backdrop, the acquisition is a key move in the field of advanced drug delivery systems, including prefilled syringes, cartridges, and autoinjectors. It's a natural next step in PCI's evolution. Last year, PCI announced an investment of more than USD 365 million to support the clinical and commercial-scale final assembly and packaging of pharmaceutical and device composite products utilizing advanced delivery systems, with a focus on injectables. This initiative, which includes the construction and expansion of infrastructure in both the U.S. and European regions, strengthens PCI's ability to manage the entire lifespan of DDC, from sterile formulation development and manufacturing to clinical trial delivery, product launch, and commercialization.

In the U.S., the investment will lead to two new large-scale facilities at PCI's Rockford, Illinois campus. Building on the success of the Philadelphia Biotech Center of Excellence, the facility features more than 25 purpose-built suites with high-speed, high-mix lines for clinical- and commercial-scale assembly and packaging of prefilled syringes, auto-injectors, vials, and pen-cartridge combinations. It incorporates extensive ISO-standard product testing capabilities and high-performance top-load cartoning technology. The campus also has the ability to assemble and package small to medium quantities of DDC. Both facilities are expected to be GMP compliant in the fall of 2025.

In Europe, PCI recently acquired a packaging and equipment assembly facility in Dundalk, Ireland, that provides commercial-scale operations for injectables and oral solid dosage forms. The company will also expand and construct a 120,000-square-foot packaging and equipment assembly services facility at its City North Dublin campus, which is expected to commence operations in the summer of 2025.

And as part of an additional $25 million investment in its León facility in Spain, PCI is now incorporating an advanced new high-speed filling line for syringes and cartridges. Equipped with isolator technology, this automated line offers exceptional flexibility and reliability to biopharmaceutical customers. The company has also recently completed a state-of-the-art biologics development lab to further enhance PCI's upstream capabilities.

With the acquisition of Altair, PCI aims to become one of the first CDMOs in the industry to bring the entire lifecycle of advanced drug delivery and drug device composite products under a single corporate structure. This initiative supports the entire clinical trial supply network, including PCI's cold chain storage solutions, through product launch and commercialization.

"Our pharmaceutical customers, as well as the healthcare professionals and patients beyond, are the driving force behind this bold investment in the area of aseptic filling and advanced drug delivery solutions," said Salim Hafar, CEO of PCI Pharma Services. "Bringing Althea's talented professionals to PCI strengthens our turnkey partnerships with our customers and ultimately improves patient outcomes through life-changing treatments We are confident that we will be able to further advance our mission."