PCI Pharma Services, a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharmaceutical therapeutics, has completed its acquisition of Ajinomoto Althea, a U.S.-based aseptic fill and finish CDMO owned by Japan-based Ajinomoto. The acquisition is a key component of PCI’s multi-year investment strategy in facilities across the U.S. and Europe. In the U.S., Althea’s assets will be integrated with PCI’s existing aseptic fill and finish and advanced drug delivery systems businesses to create a world-class, large-scale manufacturing facility in San Diego, featuring a state-of-the-art large-scale aseptic fill and finish facility dedicated to prefilled syringes and cartridges. Among other categories, the Althea campus also excels in customized, scalable oligonucleotide and peptide manufacturing, which will augment PCI’s existing capabilities in complex formulations and lyophilization processes for a variety of injectable dosage forms, including nanoparticles, mRNA, monoclonal antibodies, proteins, and other biologics.
The acquisition also adds high-activity vial filling and lyophilization capabilities, which not only expands PCI’s aseptic filling capacity, but also enables it to efficiently enter the rapidly emerging field of oncology treatment – the production of highly active antibody-drug conjugates (ADCs). In fact, this acquisition makes PCI one of the few CDMOs in the United States with ADC filling capabilities. The company began to move into this field earlier this year, establishing an advanced new drug development laboratory for the production of active and inactive compounds at its Center of Excellence in Bedford, New Hampshire. The Bedford aseptic filling expansion project began with a large-scale investment in a dedicated facility equipped with dual freeze dryers and advanced large-scale isolator filling lines that meet Appendix 1 requirements, and will complete GMP certification this summer. Since breaking ground in 2022, PCI has systematically developed aseptic design processes and is committed to providing fully isolated large-scale vial filling and lyophilization solutions.
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With this in mind, this acquisition is a natural move for PCI to grow in the field of advanced drug delivery systems such as prefilled syringes, cartridges and auto-injectors . Last year, PCI announced an investment of more than $365 million to support clinical and commercial-scale final assembly and packaging of drug-device combination products using advanced drug delivery systems, with a focus on injectable dosage forms. This work includes the construction and expansion of infrastructure in the United States and Europe, enhancing PCI’s ability to manage the entire life cycle of DDCs, covering the entire process from sterile formulation development and production to clinical trial supply, product launch and commercialization.
In the United States, the investment includes the construction of two large new facilities at PCI’s Rockford, Illinois campus. Building on the company’s success at the Philadelphia Center of Excellence for Biotechnology, these new facilities will house 25 dedicated combination spaces, equipped with high-speed, multi-format production lines for clinical and commercial-scale assembly and packaging of prefilled syringes, auto-injectors, vials and pen cartridges, and will feature comprehensive ISO-standard product testing capabilities and advanced top-loading cartoning technology. The campus also has low- and medium-scale DDC product assembly and packaging capabilities, and both facilities will complete GMP certification in the fall of 2025.
“Our pharmaceutical customers and the healthcare professionals and patients they serve are at the heart of every advancement we make as we have an ambitious investment plan in sterile filling and advanced drug delivery solutions,” said Salim Haffar, CEO of PCI Pharma Services. “This latest development adds to Ajinomoto Althea’s long-standing reputation for producing novel biologics across a broad range of injectable dosage forms. We are excited to welcome Althea’s talented professionals to the PCI family, which reinforces our commitment to providing a one-stop customer partnership, ultimately supporting our mission of improving patient outcomes through life-changing therapies.”
SOURCE: Businesswire