PCI Pharma Services, a global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies, is acquiring an entire equity stake in Ajinomoto Althea Inc. (Althea), a U.S.-based sterile fill-finish CDMO and 100% subsidiary of Japan-based Ajinomoto Co. Inc.

Scheduled for completion in May 2025, the acquisition provides PCI with its first-ever North American manufacturing location for prefilled syringes and cartridges, including isolator technology for these formats, as well as high-potent manufacturing suitable for antibody-drug conjugates (ADCs).

Althea’s clinical- and commercial-stage services for injectable drug products augment PCI’s deep industry experience, aligning with the company’s global sterile fill-finish capabilities and established expertise in advanced drug delivery. In addition, Althea’s substantial knowledge base, skillsets and capacity in scalable, custom oligonucleotides and peptides complement PCI’s existing manufacturing capabilities in complex formulations and lyophilization across a broad range of injectables – including nanoparticles, mRNA, MABs, proteins, and other biologics for delivery formats such as vials, bottles, prefilled syringes and autoinjectors.

The acquisition also adds high-potent vial filling with lyophilization, making PCI capable of producing the emerging oncology modality of antibody-drug conjugates (ADCs). Building upon PCI’s legacy in high-potent molecules, the strategy creates an end-to-end offering for clients via specialized capabilities across the globe and broadens its biologics development and manufacturing leadership.

For PCI’s advanced drug delivery systems and drug-device combination business, Althea’s assets supplement PCI’s leadership position in final device assembly and packaging facilities in both Europe and North America. Acquiring Althea’s San Diego campus also makes PCI one of the largest manufacturing centers in the U.S. West Coast’s biopharma stronghold and is a natural extension of PCI’s current clinical trial services and early phase robotic sterile fill-finish capabilities, creating a scalable, flexible manufacturing complex with facilities within minutes of each other.

“To continue supporting the needs of our customers in their endeavors to bring life-changing therapies to patients, PCI continues to make sizable investments in the sterile fill-finish category that bring additional capabilities, capacity and technologies into our portfolio,” said Salim Haffar, CEO of PCI Pharma Services. “Welcoming Althea into the PCI family expands our capabilities to support several therapeutic and drug delivery modalities, including the emerging ADC marketplace, and complements our broad end-to-end solutions alongside clinical trial services and advanced drug delivery.”

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