PCI Pharma Acquires Ajinomoto Althea as Part of $1B Investment to Boost U.S. Aseptic Fill-Finish Capacity
PCI Pharma Services, a globally recognized contract development and manufacturing organization (CDMO) specializing in the development and commercialization of innovative biopharmaceutical therapies, has officially announced the successful acquisition of Ajinomoto Althea, Inc. (“Althea”). Althea, formerly a subsidiary of Ajinomoto Co., Inc. based in Japan, is a prominent US-based CDMO with a specialized focus on sterile fill-finish manufacturing. This acquisition marks a pivotal moment in PCI’s long-term growth strategy and investment roadmap, particularly as the company accelerates its position as a leader in high-value, complex biopharmaceutical manufacturing and drug delivery technologies.
For PCI, this acquisition represents a major cornerstone in a multi-year expansion initiative designed to enhance the company’s footprint and capabilities across both the United States and Europe. Strategically, Althea’s integration into PCI’s network significantly reinforces PCI’s capabilities in sterile fill-finish services and advanced drug delivery systems, while positioning the company to meet growing global demand for sophisticated injectable biologics and drug-device combination (DDC) products.
Establishing a World-Class Manufacturing Hub in San Diego
At the heart of this acquisition lies Althea’s highly regarded manufacturing campus in San Diego, California. With its state-of-the-art aseptic manufacturing infrastructure, including advanced capabilities in prefilled syringes and cartridge formats, the site is set to become a cornerstone of PCI’s North American sterile product operations. The integration of Althea’s facilities with PCI’s existing sterile fill-finish and drug delivery systems creates a large-scale, end-to-end manufacturing hub designed to deliver tailored solutions for complex injectables, including biologics and novel therapeutic platforms.
Althea’s facility also brings specialized expertise in the production of scalable oligonucleotides and peptides—categories of increasing relevance in the development of next-generation therapeutics. These capabilities complement PCI’s already strong portfolio in complex formulations, nanoparticle technologies, and lyophilization, enabling the company to provide comprehensive support for advanced injectable therapeutics such as mRNA, monoclonal antibodies (MABs), proteins, and other biologics.
Enhancing High Potency Capabilities and Entry into ADC Manufacturing
The acquisition further enhances PCI’s sterile fill-finish capabilities by adding high potent vial filling and lyophilization infrastructure, positioning the company to meet the rising demand for high potency biologics. In particular, this move allows PCI to significantly expand its presence in the rapidly growing market for antibody-drug conjugates (ADCs), a therapeutic class that combines targeted biologics with cytotoxic agents to treat cancer more precisely and effectively.
With Althea’s high containment facilities and aseptic handling expertise now part of its arsenal, PCI joins a select group of US-based CDMOs equipped to manufacture ADCs at clinical and commercial scales. This milestone builds upon PCI’s previously announced investment in its Center of Excellence in Bedford, New Hampshire, where a PCI Pharma sophisticated pharmaceutical development lab was established earlier this year to support both potent and non-potent compound development.
The Bedford expansion project includes a purpose-built sterile manufacturing facility featuring twin lyophilizers and a modern, large-scale isolator filling line. Designed in full compliance with EU GMP Annex 1 standards, the facility is slated to become operational by summer 2025. Since breaking ground in 2022, PCI Pharma has embedded aseptic-by-design principles throughout the facility’s architecture and operational framework, reinforcing its commitment to safe, high-quality, and scalable manufacturing of high-potency sterile products.
A Multi-Year Investment Plan to Advance Drug-Device Combination Products
The acquisition of Althea aligns closely with PCI’s broader strategic vision to become a global leader in advanced drug delivery and drug-device combination solutions. In 2023, PCI announced over $365 million in investments aimed at expanding its PCI Pharma capabilities in the clinical and commercial manufacturing, final assembly, and packaging of combination products—particularly those that involve injectable delivery systems.
These investments include the construction of new infrastructure and the expansion of existing facilities across both the United States and Europe. In the U.S., PCI is building two large-scale, purpose-driven facilities at its PCI Pharma Rockford, Illinois campus. These state-of-the-art buildings will house over 25 dedicated suites featuring high-speed, multiformat lines for the assembly and packaging of prefilled syringes, autoinjectors, pen-cartridge systems, and vials. The facilities are also equipped with advanced ISO-standard product testing labs and cutting-edge top-load cartoning equipment.
In addition to large-scale manufacturing, the Rockford site will also accommodate small- and medium-scale production needs, offering comprehensive flexibility for biopharmaceutical customers across different phases of product development. The facilities are scheduled to be GMP-ready by fall 2025.
European Expansion: Ireland and Spain Take Center Stage
PCI’s expansion is equally robust in Europe. In Ireland, PCI recently acquired a device assembly and packaging facility in Dundalk, which is now a cornerstone for the company’s European injectable and oral solid dose operations. The Dundalk site supports PCI Pharma commercial-scale assembly and distribution, adding much-needed capacity to serve global customers with an emphasis on quality, scalability, and regulatory excellence.
Additionally, PCI has invested in expanding its City North Dublin campus, where a new 120,000-square-foot packaging and device assembly facility is under construction. This facility, set to begin operations in summer 2025, will play a key role in PCI’s European strategy for injectable drug-device combinations and biologics packaging.
Elsewhere in Europe, PCI is investing $25 million into its León, Spain site to incorporate a high-speed filling line for cartridges and syringes. Equipped with isolator technology, the automated line will offer unparalleled flexibility and PCI Pharma efficiency for biopharma clients seeking reliable, high-throughput solutions. This investment also includes a recently opened biologics development laboratory, providing upstream support and innovation capacity for clients engaged in complex biologic development.
A Unified Vision: Bringing the Full Lifecycle Under One Roof
With the acquisition of Ajinomoto Althea, PCI is well-positioned to become one of the first CDMOs capable of providing a full-spectrum service offering under one corporate umbrella—from early-phase development and clinical trial supply through commercial launch and post-marketing support. PCI’s integrated network of sterile manufacturing, cold chain storage, clinical packaging, and global logistics gives clients a seamless PCI Pharma pathway from molecule to market.
This comprehensive, end-to-end offering is especially valuable in today’s biopharmaceutical landscape, where advanced therapies increasingly require specialized manufacturing environments, reliable cold chain solutions, and streamlined supply chains to accelerate speed to market and ensure consistent product quality.
CEO Perspective: A Vision for the Future of Biopharma Manufacturing
Commenting on the acquisition, Salim Haffar, CEO of PCI Pharma Services, emphasized the importance of this milestone for both the company and the industry at large.
“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,” Haffar stated. “Ajinomoto Althea enjoys a longstanding, well-earned reputation for producing novel biologics in PCI Pharma various injectable formats. Welcoming Althea’s talented PCI Pharma 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.”
As PCI continues its strategic expansion across continents, its growing global footprint and best-in-class capabilities reaffirm its role as a trusted partner in the development, manufacturing, and commercialization of the world’s most promising biopharmaceutical therapies.
