ROIS CDMO: A New Brand, a Bold Acquisition, and a Global CDMO Vision for Next-Generation Injectables

Sponsored by ROIS CDMO

In this interview, Miguel Ángel Ortega Sánchez, Corporate Industrial Director at ROIS CDMO, explains how the company’s new brand identity marks its evolution into a tier-1 global CDMO specializing in high-value injectables. The rebrand reflects ROIS’s commitment to scale, invest, and operate as a dedicated partner for sterile and high-potent drug development and manufacturing.

Miguel highlights the strategic importance of the Phoenix, Arizona acquisition, which brings FDA-, EMA-, and PMDA-approved capabilities, OEB5 high-potent handling, and expanded lyophilization capacity. The site also provides invested space for new pre-filled syringe (PFS) lines, giving ROIS a strong foothold in the US market, offering customers shorter lead times and direct regulatory support. Combined with ROIS’s European network, clients now gain a truly global partner for clinical and commercial supply.

Looking ahead, Miguel outlines ROIS’s 2026–2027 expansion roadmap, including full Phoenix integration, the launch of a new Optima PFS isolator line adding 65–70 million PFS units of annual capacity, and expanded device assembly. He emphasizes the critical role of automation and AI-driven systems to accelerate tech transfer, improve quality, and support scalable operations.

The conversation closes with a look at how ROIS is preparing to meet surging demand for GLP-1s and next-generation injectables, with dedicated line designs, Annex 1 compliance, optimized formulation environments, and streamlined tech-transfer processes.

ROIS is positioning itself as a global, end-to-end CDMO partner equipped to take programs from development to commercial supply with speed, reliability, and world-class quality.