Our cGMP process produces the highest quality of mRNA, from 10 mg to 100 grams. Built around a single use, fully enclosed container system, our process is highly robust and reliable.
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Adjusted to your needs
To exclude unnecessary risks, both late stage pre-clinical studies and clinical trials often performed with full GMP-grade API. Therefore, our cGMP services start at small scales of 10 mg of mRNA, suitable for smaller studies, and can be seamlessly scaled to 100 grams, suitable for large Phase III studies.
Furthermore, our smaller scales also bring personalized medicine and rare disease treatment within reach.
How we make the difference
The transition from pre-clinical research to the clinic is an exciting, but critical milestone, especially for mRNA because of the novelty of the product.
Therefore, you need a partner that truly understands mRNA to navigate those choices that affect the entire life-cycle of your product. Based on more than a decade of experience in mRNA, RIBOPRO is your premier partner from R&D to GMP.
Our GMP services are part of a line of services that enable mRNA therapy pioneers to develop the medicines of the future. Starting with mRNA- and therapy-design, followed by R&D- and GMP-grade CDMO services, and finally commercial manufacturing, our one-stop shop has you covered.
Even better, our licensable technologies on mRNA design, manufacturing processes, and LNP formulations provide you a head start in your clinical trials and in the competitive marketplace.
It is our mission to help you get to market with the absolute best product. Therefore, our licenses are fair and our services generous.
mRNA DESIGN
Using our patented technologies, we boost expression, avoid innate immunity, and optimize half-life.
R&D-GRADE MFG.
De novo DNA synthesis - Cloning - Scalable IVT - Capping, Purification & optional LNP formulation - Scale 100 µg - 100 g.
GMP-GRADE MFG.
Enzymatic DNA amplification - Scalable IVT - Capping and Purification - LNP via partner - Scale 10 mg - 100 g.
Coming in 2025: Next level GMP
Proprietary flow-based, fully automated production system. kg-scale/24 h
Clean & compliant
mRNA manufacturing is performed in our modern facility in GMP Grade A and Grade C cleanrooms (ISO 14644 classified), which are fully equipped with state-of-the-art processing and quality control devices.
Digital GMP-compliant systems provide full-tracebility throughout the process.
How we ensure quality
We offer a full-range of analytical methods, including: CGE, UV-spectroscopy, HPLC-UV, HPLC-MS, dsRNA detection via ELISA, a proprietary Capping efficiency assay, Sanger sequencing, NGS, sterility testing, as well as pH and salinity verification. Additional QC-assays are available upon request.
Upon verification of adherence to the pre-determined specifications, release and certification is performed according ot the Ph. Eur.
Finally, we provide sterile packaging in one or more bulk formats.
Clean & compliant
Stability studies on the drug substance are performed conform ICH standards for at least 12 months.
A wide variety of testing conditions is possible, including: -80°C, -70°C, -20°C, 4°C, 20°C, 37°C, 50°C, RH 0-95%, normoxic and anoxic atmosfere.
By working with RIBOPRO, you gain a trust-worthy, knowledgeable, and experienced partners that shares your passion for bringing novel medicines to market.