ROIS

Overview

ROIS is a sterile injectable CDMO that describes itself as one of the top three sterile CDMO capacities for injectables worldwide. The company reports about 1,900 employees across the US and Europe, more than 50 years in sterile manufacturing, and product supply to more than 75 global markets.

Sterile fill-finish

• Prefilled syringes (PFS), cartridges and vials for late-phase and commercial supply
• Sterile manufacturing on 14 filling lines using RABS or isolator technology, all described as Annex 1-compliant
• Cytotoxic filling and lyophilization, including a dedicated US-based facility for OEB5 cytotoxic manufacturing
• Sterile fill-finish for biologics, vaccines, peptides and GLP-1s, ADCs and biosimilars

Packaging and integrated services

• Analytical and stability studies
• Packaging and device assembly
• Warehousing and logistics

Oral solids and drug substance

Beyond sterile fill-finish, ROIS supports large-scale oral solid dose manufacturing and drug substance development and GMP manufacturing.

Network

The company lists a network of five manufacturing sites: Phoenix (USA), and Madrid, San Sebastián de los Reyes, Alcalá de Henares and Granada (Spain). The site states that its network has hosted inspections from FDA, EMA and other global regulators.

Capacity

The site cites annual capacity of 800 million units across PFS, cartridges and vials, and describes itself as a single accountable partner for complex injectable programs.