Built for complex manufacturing

As mRNA medicines continue to expand beyond vaccines into new therapeutic areas, successful manufacture depends on specialist sterile manufacturing, proven quality systems and reliable commercial supply.

mRNA medicines and lipid nanoparticle (LNP) formulations present unique manufacturing challenges:

• Precise, tightly controlled sterile processes
• Careful handling of highly sensitive drug products
• Robust quality systems to maintain product integrity
• Scalable capacity and regulatory expertise to support growing global demand

ROIS combines decades of sterile manufacturing expertise with one of the top three sterile CDMO capacities for injectables worldwide, supporting the sterile fill-finish capabilities complex mRNA drug products require. Through strategic manufacturing partnerships and proven commercial-scale operations, ROIS simplifies the transition from drug substance to reliable global drug product supply.

From seasonal immunization programs to next-generation vaccine platforms, successful manufacture depends on proven sterile manufacturing expertise, commercial-scale capacity and uncompromising quality to provide reliable global supply.

Vaccine manufacture demands precise sterile processes and rigorous global regulatory compliance:

• Robust quality systems and consistent batch performance
• Flexibility and speed in commercial-scale production
• Reliable supply and uncompromising product quality across evolving vaccine platforms

As a manufacturing partner for Moderna’s Spikevax® COVID-19 vaccine, ROIS has demonstrated the capability, quality and manufacturing flexibility complex vaccine programs require, from technology transfer through commercial supply.

As peptide therapeutics and GLP-1 therapies continue to reshape global healthcare; successful manufacture depends on scalable sterile manufacturing, proven expertise and reliable commercial supply.

Rapidly increasing demand for peptide and GLP-1 therapies has placed unprecedented pressure on global manufacturing capacity. ROIS has risen to the challenge with:

• Robust sterile manufacturing processes
• Consistent product quality
• Flexible capacity and reliable supply chains
• Compliance with stringent regulatory standards

With one of the top three sterile CDMO capacities for injectables worldwide, ROIS is already helping pharmaceutical and biotechnology companies meet growing commercial demand for peptide and GLP-1 therapies. Proven quality systems, flexible manufacturing capacity and global regulatory approvals support reliable long-term supply as programs scale.

As one of the fastest-growing areas of oncology, ADC manufacture demands specialist expertise and high-containment manufacturing to provide complex therapies safely and reliably.

ADC drug products combine the complexity of biologics with the handling requirements of highly potent compounds:

• Specialist containment and robust sterile processes
• Seamless technology transfer
• Rigorous quality systems that protect product integrity and operator safety
• Reliable commercial supply

ROIS combines decades of sterile manufacturing expertise with specialist high-containment facilities for cytotoxic drug products. Through strategic partnerships ROIS can offer an integrated pathway from drug substance through to aseptic fill-finish, helping simplify the technology transfer process and accelerate the journey to commercial supply.

Biosimilars are an increasingly important class of biologic medicines designed to deliver comparable safety, efficacy and quality to approved reference products. Our aseptic fill-finish capabilities support the commercialization of biosimilars across a range of dosage formats, helping customers bring high-quality, cost-effective therapies to patients worldwide.

Manufacturing biosimilars requires exceptional process consistency and regulatory rigor:

• Batch-to-batch reproducibility
• Demonstrating comparability to the reference product
• Robust quality systems and sterile manufacturing processes
• Capacity and supply continuity to support global markets without compromising product quality

ROIS combines decades of sterile manufacturing expertise with one of the top three sterile CDMO capacities for injectables worldwide, supporting biosimilar programs as they scale for commercial supply. Rigorous process controls and consistent batch performance help maintain the comparability biosimilar programs depend on, supporting reliable long-term supply.

From monoclonal antibodies (mAbs) and recombinant proteins to next-generation biologic therapies, successful manufacture depends on specialist sterile manufacturing expertise, commercial-scale capacity and uncompromising quality to ensure every dose reaches patients safely.

ROIS addresses the unique manufacturing challenges of scaling biologics from clinical development to commercial production:

• Tightly controlled sterile processes for sensitive molecules
• Robust quality systems and consistent batch performance to protect product integrity
• Capacity, regulatory expertise and supply continuity to support global markets

Commercial biologics demand more than manufacturing expertise; they require the capacity, quality and supply continuity to support long-term success. ROIS combines decades of sterile manufacturing expertise with one of the top three sterile CDMO capacities for injectables worldwide, supporting biologics programs from technology transfer through commercial supply.