Drug substance
ROIS operates a dedicated facility for biologics, mRNA and lipid nanoparticle drug substance manufacturing.


Capability overview
The ROIS drug substance facility in Granada, Spain specializes in biologics API manufacturing, with demonstrated experience in mRNA and lipid nanoparticle (LNP) production for vaccine programs including COVID-19, influenza and RSV.
Operating across 4,822 m² of manufacturing space, the site is fully integrated into the ROIS network, supporting drug substance supply through to sterile fill-finish across European and US facilities.

From drug substance to drug product
Combining drug substance capabilities with extensive sterile manufacturing expertise creates opportunities to support programs across more of the manufacturing journey. Experienced teams can help manage technology transfer, manufacturing requirements and the transition toward sterile fill-finish and commercial supply.
Talk through your drug substance requirements
Whether you are preparing for technology transfer, evaluating manufacturing capacity or planning the transition from drug substance to drug product, talk to ROIS about the manufacturing approach best suited to your program.
FAQs
The Granada facility provides dedicated drug substance manufacturing capabilities for biologics, mRNA and lipid nanoparticles. Specialist infrastructure and technical expertise support pharmaceutical and biotechnology partners requiring manufacturing solutions for these complex product types.
Drug substance manufacturing is located at the dedicated Granada facility in Spain, providing specialist capabilities for biologics, mRNA and lipid nanoparticles within the wider ROIS European and US manufacturing network.
No. The Granada drug substance offering focuses on biologics, mRNA and lipid nanoparticles rather than traditional small-molecule API manufacturing. This specialist focus complements ROIS’ broader expertise in sterile drug product manufacturing and commercial supply.
ROIS combines dedicated drug substance capabilities with extensive sterile fill-finish capacity across its manufacturing network, creating opportunities to support both stages of manufacture. Program requirements can be assessed to determine the most appropriate manufacturing and technology transfer pathway.
News and resources
Personalized partnerships. Global reach.
Connect with the ROIS team to explore how this capability can support the next program.







