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.
Built for scale
Supporting end-to-end late-phase and commercial manufacturing for complex injectable drug products including prefilled syringes, cartridges and vials, with specialized expertise in biologics, segregated cytotoxic lyophilization and ADC fill-finish, plus downstream services including packaging, device assembly and quality release.
700M+ PFS/year
100M+ vials/year
14 aseptic lines
16 packaging lines
Explore further
Cytotoxic filling and lyophilization
Formats
Packaging and integrated services
FAQs
ROIS provides sterile fill-finish across prefilled syringes, cartridges and vials, with flexible manufacturing capabilities supporting complex injectable products from late-stage clinical programs through commercial supply. Its global capacity exceeds 800 million units annually across these formats.
Yes. ROIS combines more than 50 years of sterile manufacturing experience with facilities across Europe and the US, providing the capacity, quality systems and regulatory experience required to support long-term commercial manufacturing and global supply.
ROIS provides sterile fill-finish, cytotoxic and high-potency manufacturing and large-scale lyophilization across its manufacturing network. These technologies support a range of complex injectable medicines, including biologics, vaccines, ADCs, biosimilars, peptides and GLP-1 therapies.
Yes. ROIS has well established technical teams to support technology transfer, scale up and commercialization.
The ROIS standard
Partnership
Collaborating with clients as strategic partners, with flexible, adaptable models
Impact
Strengthening the supply of medicine to patients through reliable manufacturing
Integrity
Steadfast standards in every submission, batch and conversation
Responsibility
Operating in a way that demonstrates responsibility to people, communities and the planet
News and resources
Personalized partnerships. Global reach.
Connect with the ROIS team to explore how this capability can support your next program.