Format flexibility for sterile programs

ROIS supports a full range of injectable formats, including prefilled syringes, cartridges and sterile vials. Each format is manufactured to match specific program requirements, from early-phase development through commercial supply.

Formats

Prefilled syringes from 0.5 mL to 20 mL
Cartridges across multiple formats and sizes
Vials from 2 mL to 100 mL, including segregated cytotoxic capability

Format capabilities at a glance

PFS

700M+ PFS and cartridges capacity

Vials

100M+ vials capacity

12 lines

12 aseptic filling lines for PFS and cartridges

5 lines

5 filling lines for vials, including 2 combo lines

Built to match program complexity

Multiple formats for sterile injectables aligned to your lifecycle evolution. ROIS capabilities include a segregated line for cytotoxic products with each format backed by ISO-certified quality systems and regulatory compliance across the EU and US.

Prefilled syringes

12 aseptic filling lines

Cartridges

High-speed cartridge filling at commercial scale

Vials

4 vial filling lines, including dedicated cytotoxic manufacturing capability

Proven quality. Regulator-approved.

Annex 1-compliant sterile manufacturing across RABS and Isolator lines
Multiple Regulatory approvals from FDA, EMA, and other major global agencies
GMP-approved facilities in Europe and the US

Choosing the right format

Selecting the right drug product format depends on your molecule, route of administration, commercial strategy and patient requirements

Tech transfer

Successful technology transfer requires experienced teams, robust processes and close collaboration to ensure efficient scale-up and manufacturing readiness

Commercial supply

Reliable commercial supply depends on scalable manufacturing capacity, proven quality systems and a trusted partner capable of supporting long-term demand

Explore further

Sterile manufacturing

ROIS provides aseptic manufacturing across 14 filling lines, with a choice of flexible, cost efficient RABS or the latest Isolator technology, all Annex 1-compliant.

Packaging and integrated services

End-to-end support spanning analytical studies, packaging, device assembly, storage and logistics; ROIS simplifies project complexity with end-to-end solutions.

Modalities

Manufacturing expertise from biologics and biosimilars to vaccines, ADCs, and emerging modalities.

Locations

Five manufacturing sites across Spain and the US give your program a consistent route from development through commercial supply.

Scale and credibility

800M

PFS, cartridges and vials per year

50 years

Sterile experience

75+ markets

Served globally

News and resources

Explore expert insights, technical perspectives and industry trends shaping the future of injectable manufacturing.

ROIS: The CDMO making waves in the US market

ROIS Phoenix Facility

ROIS CDMO closes on the acquisition of US injectable manufacturing facility

Water for injection: why WFI is now a strategic manufacturing decision

Our locations

Phoenix

ROIS Phoenix is a commercial-scale sterile manufacturing facility specializing in cytotoxic and ADC fill-finish for late-phase and commercial programs.

Madrid

ROIS Julian Camarillo is a commercial-scale sterile injectable manufacturing facility specializing in prefilled syringe fill-finish for investigational and commercial products.

San Sebastián de los Reyes

Specializing in commercial-scale sterile manufacturing of aseptic fill-finish of small-volume injectable products across vials, prefilled syringes, and cartridges.

Alcalá de Henares

ROIS Alcala de Henares is a commercial-scale pharmaceutical manufacturing campus specializing in oral solid dose manufacturing, injectable packaging, and drug-device assembly.

Granada

ROIS Granada is a Drug Substance Center of Excellence specializing in complex API development, mRNA technologies, and lipid nanoparticle (LNP) formulation.

Personalized partnerships. Global reach.

Connect with the ROIS team to explore how this capability can support the next program.