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ROIS Expands U.S. Footprint with Acquisition of Phoenix Manufacturing Site

Aims to become one of the world’s top three injectable CDMOs

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By: Charlie Sternberg

Associate Editor

ROIS, the CDMO arm of ROVI, has completed its acquisition of an injectable drug‑product manufacturing and packaging facility in Phoenix, Ariz., from Bristol Myers Squibb. The transaction marks a significant expansion for the company, which has operated primarily in Europe, and positions it to offer U.S.-based sterile manufacturing for the first time.

The deal follows the company’s 2025 rebranding effort, which aimed to highlight ROIS’s ambition to become one of the world’s top three injectable CDMOs. Executives said the newly acquired Arizona site strengthens that strategy.

“This acquisition demonstrates where we are headed,” said Kimberlee Steele, the company’s recently appointed Chief Commercial Officer. “We are establishing ROIS as a top 3 global CDMO for sterile fill-finish — growing, investing, and expanding capacity to meet our partners’ needs worldwide.”

The roughly 370,000‑square‑foot site has received about $100 million in capital investment since 2021 and includes a high‑potency cytotoxic area with commercial-scale lyophilization capacity, according to the company. The facility holds regulatory approvals from the FDA, EMA and Japanese authorities.

ROIS plans to install an Optima pre‑filled syringe isolator line in a segregated, non‑potent area by 2027. Once operational, the line is expected to add an annual capacity of roughly 65 million to 70 million pre‑filled syringes. The plant will support commercial‑scale sterile fill‑finish and packaging across vials, syringes and cartridges.

With the additional U.S. capacity, ROIS said it can now provide more flexible global production of injectable medicines, with a network capable of producing more than 800 million sterile units per year. The expansion will also support U.S.-based manufacturing of high‑potency liquid and lyophilized products, including antibody‑drug conjugate fill‑finish.

“The Phoenix site adds significant sterile fill-finish and high-potent capability, enabling us to better serve partners on U.S. soil while continuing to invest across our network,” Steele added.

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