You will soon have access to our next level GMP-grade formulated xRNA.
On this page you can find the latest information.
Book a meeting with our Product Specialists to find out more about how RIBOFLUXTM can be used to your advantage.
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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. To exclude unnecessary risks, pre-clinical studies and clinical trials are often performed with GMP-grade API.
Some of the challenges of GMP are the long manufacturing timelines, scalability and sufficient availability of manufacturing slots at your CDMO. RIBOFLUXTM offers the solution for these challenges, as it does not only offer a wide scale starting at 10 mg to 1 kg, it also allows a much faster manufacturing rate of 40 slots per week, whereas manual GMP manufacturing allows for 2 slots a month.
By developing a portable, flow-based, fully automated, GMP-compliant machine, RIBOPRO makes it possible to have RNA-in-a-DayTM. With the largest microfluidic cartridge in the world, we scale and adapt from personalized medicine, to innovative therapeutics, and to pandemic-fighting vaccines.
THE ULTIMATE E-2-E SOLUTION
Producing (formulated) mRNA with RIBOFLUXTM will give you RNA-IN-A-DAYTM* because of our:
• On demand E-2-E manufacturing of formulated xRNA
• Completely closed, single-use microfluidic cartridge
• Integrated QC in a closed cartridge
• GMP grade tailored to your development phase
• Ultra-scalable platform from 10 mg to 1 kg of mRNA
Making it suitable for both Tx, Vx and personalized medicine on a small footprint of only 1 m².
* This timeline applies for a GMP-ready process and is excluding a possible feasibility study, project optimalisation, supply of raw materials, preparation time, release testing and shipment.
Our unique innovations
We use our proprietary technologies to make sure that our customers can get their (c)GMP products fast & reliable, including:
• Our in-house developed range of T7 RNA polymerases (RIBOPERFECTTM)
• Perfecting the chips using injection molding.
• RIBOFLUXTM One single system: from DNA to mRNA to LNPs
Thorough quality controls
To ensure that all our customers are satisfied and that we meet regulatory requirements, we offer a broad selection of QC analyses:
Range of QC:
• UV-spectroscopy
• HPLC-UV
• HPLC-MS
• dsRNA detection via ELISA
• Proprietary Capping efficiency assay
• Sanger sequencing
• NGS
• Sterility testing
• pH and salinity verification
Additional QC-assays are available upon request.
Guaranteed stability
Various conditions for stability testing are offered to ensure that your final drops of product can be just as effective as your first ones.
Stability conditions:
• performed on both Drug Substance and Drug Product
• conform ICH standards for at least 12 months
• -80°C, -70°C, -20°C, 4°C, 20°C, 37°C, 50°C
• RH 0-95%, normoxic and anoxic atmosfere
Clean & compliant
• mRNA / LNP manufacturing is performed in a GMP approved facility in a fit-for-purpose GMP compliant grade C cleanroom.
• The digital GMP-compliant systems provide full-traceability throughout the process.
• Sterile Fill & Finish is offered through a partner CDMO