PCI to Purchase Full Stake in Ajinomoto Althea

Image Credit: Business Wire

PCI Pharma Services, a contract development and manufacturing organization (CDMO), will be purchasing a full stake in Ajinomoto Althea, Inc., a sterile fill-finish CDMO and subsidiary of Japan-based Ajinomoto Co., Inc., for an undisclosed amount.¹

The deal is anticipated to be completed by May, and gives PCI its first-ever North American manufacturing hub—located in San Diego, CA—containing prefilled syringes and cartridges, including isolator technology for these formats, along with high-potent manufacturing for the production of antibody-drug conjugates (ADCs).

As a result of Althea’s clinical- and commercial-stage service offerings for injectable drug products, the acquisition is expected to boost PCI’s services, in an effort to not only increase its sterile fill-finish experience, but its advanced drug delivery efforts as well. The knowledge and experience in lyophilization and complex formulations brought to the table by Althea also serves as an asset to PCI’s services.

“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.”

Last August, the CDMO completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, NH campus, making it the first drug product CDMO to complete the multi-agency inspection process, which is a component of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program. This initiative focuses on the assessment of facilities that product therapies under the organization’s supervision.

PCI’s Bedford campus—which has been powered by over $100 million in infrastructure enhancements³—specializes in sterile fill-finish and lyophilization, which are often used during the injectable and biologic therapy processes. This particular campus manufactures various drugs for both the domestic and international markets.

“We’re honored to have been selected as the first CDMO to participate in the ICMRA’s pilot program, allowing for agencies across the globe to conduct their regulatory approval process simultaneously,” commented Tom McGrath, the company’s vice president of global quality for manufacturing & development. “The program’s collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging, and ultimately commercializing life-changing therapies.”

References

1. PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea. Business Wire. April 24, 2025. Accessed April 24, 2025. https://www.businesswire.com/news/home/20250424617540/en/PCI-Pharma-Services-to-Acquire-US-based-Aseptic-Fill-Finish-CDMO-Ajinomoto-Althea

2. Saraceno N. PCI’s Bedford Plant Completes ICMRA Inspection. Pharmaceutical Commerce. August 30, 2024. Accessed April 24, 2025. https://www.pharmaceuticalcommerce.com/view/pci-bedford-plant-icmra-inspection

3. Saraceno N. PCI Pharma Services Begins Expansion Project. Pharmaceutical Commerce. May 9, 2024. Accessed April 24, 2025. https://www.pharmaceuticalcommerce.com/view/pci-pharma-services-begins-expansion-project