News|Articles|April 13, 2026

ROIS Expands US Injectable Manufacturing Capacity

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Key Takeaways

ROIS’s Phoenix facility adds commercial sterile fill/finish across vials, PFS, and cartridges, alongside lyophilization, addressing growing demand for complex injectable formats in oncology pipelines.
OEB 5 high-potent infrastructure directly supports ADC manufacturing needs, where cytotoxic payload containment, operator safety, and specialized handling are prerequisites for compliant, scalable production.
Existing FDA, EMA, and Japanese regulatory approvals position the site to supply global clinical and commercial programs with reduced time-to-activation compared with greenfield or non-licensed capacity.
Planned installation of a PFS isolator line by 2027 is expected to add ~65–70 million units annually, reflecting market pull toward device-enabled accuracy and patient-centric administration.
Expanded US–EU network increases geographic redundancy and supply-chain resilience while bringing ROIS’s stated total capacity above 800 million sterile units annually for development-through-commercial demand.

With the closing of an acquisition, ROIS adds high-potent fill/finish and lyophilization capabilities to support biologics and ADC pipelines, addressing global supply and scalability challenges.

Global capacity constraints in sterile injectables, especially for high-potent therapies like antibody-drug conjugates (ADCs), are driving contract development manufacturing organizations (CDMOs) to expand geographically and technologically to support increasingly complex pipelines. Responding to this need, Spain-based CDMO, ROIS, announced the completion of its acquisition of a US-based injectable manufacturing and packaging facility in Phoenix, Ariz., from Bristol Myers Squibb in early April 2026.¹

The move marks a significant step in establishing ROIS as a global CDMO with both European and US sterile manufacturing capabilities, according to the company.

Why is US-based sterile manufacturing capacity critical for biologics and ADCs?

The newly acquired approximately 370,000-square-foot facility adds commercial-scale sterile fill/finish capabilities across vials, prefilled syringes (PFSs), and cartridges. The site includes a cytotoxic/high-potent manufacturing area (Occupational Exposure Band 5 classification) and lyophilization infrastructure. These capabilities are increasingly in demand as oncology pipelines shift toward more complex biologics and ADCs.¹

High-potent manufacturing is particularly relevant for ADCs, which require specialized containment and handling to safely process cytotoxic payloads. With regulatory approvals already in place from FDA, the European Medicines Agency, and Japanese authorities, the site is positioned to support global clinical and commercial supply without significant delays.

“This acquisition is a strategic step in building ROIS as a global CDMO for high-value injectables. The Phoenix site adds significant sterile fill/finish and high-potent capability, enabling us to better serve partners on US soil.”

ROIS plans to further expand capacity by installing a PFS isolator line by 2027, which is expected to add approximately 65–70 million units annually once the line becomes operational. This further expansion reflects industry demand for advanced delivery formats that improve dosing accuracy and patient convenience.

How does this acquisition reshape global CDMO strategy?

By adding US-based production, ROIS addresses a growing need among biopharma companies for geographically diversified manufacturing networks. Supply chain resilience, regulatory alignment, and proximity to key markets have become central considerations in outsourcing strategies.²

The expansion brings ROIS’s total global capacity to more than 800 million sterile units annually, positioning the company to support both early-stage development and large-scale commercial manufacturing. This scale is increasingly important as biologics pipelines grow and timelines compress.

“This acquisition demonstrates where we are headed,” said Kimberlee Steele, chief commercial officer at RIOS, in a company press release.¹ “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.”

What does this expansion mean for the broader injectable manufacturing landscape?

The deal underscores intensifying competition among CDMOs to secure specialized infrastructure for high-value injectables, particularly as demand rises for oncology therapies and advanced biologics. Facilities capable of handling high-potent compounds and supporting multiple delivery formats are becoming strategic assets.³

“This acquisition is a strategic step in building ROIS as a global CDMO for high-value injectables,” Steele added in the release. “The Phoenix site adds significant sterile fill/finish and high-potent capability, enabling us to better serve partners on US soil.”

As drug development shifts toward more complex modalities, access to scalable, compliant, and flexible manufacturing capacity will remain a key bottleneck and a defining factor in how quickly therapies reach patients.

References

ROIS. ROIS CDMO closes on the acquisition of US Injectable Manufacturing Facility. Published April 1, 2026. Accessed April 13, 2026. https://roiscdmo.com/rois-cdmo-closes-on-the-acquisition-of-us-injectable-manufacturing-facility/
Bastani P, Dehghan Z, Kashfi SM, et al. Strategies to improve pharmaceutical supply chain resilience under politico-economic sanctions: the case of Iran. J Pharm Policy Pract. 2021;14(1):56. doi: 10.1186/s40545-021-00341-8
Kadan, M. What economic or market trends are having the biggest impact on CDMO capacity and pipelines in 2025, and what will 2026 bring? Nov. 2, 2025. Accessed April 13, 2026. https://vectorbiomed.com/resource/what-economic-or-market-trends-are-having-the-biggest-impact-on-cdmo-capacity-and-pipelines-in-2025-and-what-will-2026-bring/

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