Master. Purify. Scale-Up.
Be Prepared for the Hidden Complexity in Your mRNA Process
Messenger RNAs (mRNAs) are a fast-emerging class of biotherapeutics. While they hold considerable promise, the field is still in its infancy. mRNA therapies offer a new opportunity for targeted treatment of challenging diseases and flexible manufacturing, as demonstrated by the rapid development of mRNA vaccines against COVID-19. The clinical potential of mRNA extends beyond vaccines to other advanced therapies, such as protein replacement, gene therapy, and cancer immunotherapy.
IVT reactions are efficient for mRNA production, and new analytical tools can help you achieve high recovery and quality.
The journey to develop new mRNA process can be complex, with hidden barriers along the way. With Sartorius, you have a partner that can empower you to
Download this interactive guide to navigating the challenges and finding solutions for your pDNA, mRNA and LNP processes.
The right analytical strategy for process optimization, in-process control and quality control is essential. A solid understanding of process performances, covering the wide spectrum of pDNA, mRNA and LNP steps can:
New types of RNA are emerging; their lengths, size and folding patterns varies, the targeted final doses are evolving. The In Vitro Transcription, commonly use for the production of mRNA, is a complex enzymatic reaction. Fast and efficient tracking of pDNA, mRNA and associated impurities is critical for success, while keeping cost-of-goods minimal. As a result, each mRNA process is unique and must be thoroughly optimized.
PATFIX platform is an at -line HPLC system, combined with the monolith technology. Specifically set for non HPLC expert to run analytics in process lab in only 5-15 minutes, .
Powerful data analytics software is used to monitor and understand the parameters affecting your process and to optimize experimental design. Modelling allows iterative optimization of the process. Simca and PATfix® enhance control and follow-up during production.
MODDE® can help improve the efficiency of your process development process by making every experiment count.
As a new and rapidly evolving field, mRNA processes are lacking standardization. New forms or mRNA are emerging, like saRNA or circRNA, and the application of mRNA beyond vaccines requires higher doses, meaning more stringent purity requirements. As a result, there is not a one-fits-all solution to purify mRNA.
Superior solutions are required for the purification of pDNA, mRNA and LNP (Lipo-Nano Particles), as these are large molecules that can be shear sensitive and may be similar to process-related impurities, such as dsRNA or truncated RNA for the mRNA process.
With multiple production platforms (saRNA, cirRNA, mRNA), with any new contruct, processes vary – as do the impurities that may be introduced. This impedes the development of a fit for purpose purification platform
Sartorius comprehensive toolbox and expertise in pDNA, mRNA and LNP purification allows to quickly and confidently maximize quality and yield:
The manufacturing process is at the core of the facility design. A robust and cost-efficient process flow has to be implemented in a fit-for-purpose facility, while allowing enough flexibility to quickly adapt to changes.
Key considerations are scale, single- vs multi-product, current titers vs future state titers, localized vs centralized manufacturing, and in-house vs outsourced pDNA manufacture.
Facility scale for mRNA production is rather small compared to mAbs and may integrate pDNA production and encapsulation. Facility design at scale is complex and may include decisions about vertical integration and segregation of appropriate areas.
For mRNA production, RNAse contamination should be avoided as it degrades RNA and contributes to shorter shelf life and lower quality.
We design a bioprocess with maximum flexibility in mind to facilitate changing requirements and tailor our offering around your business scenario. Integrated solutions can bridge gaps between engineering firms and scientific solutions to recommend optimal facility design.
End-to-end closed single-use processing solutions with aseptic connections and disconnections prevent RNAse contamination.
We provide a unique implementation methodology for your bioprocess using SU technologies and hybrid solutions for your type & scale of process.
The Fast, Flexible, and Intelligent Single-Use Mixer for All Mixing Steps in cGMP Bioprocessing. Mix Smarter - Not Harder.
Sartorius offers multiple disconnection technologies, with proven sterility assurance, to accommodate your specific process requirements.
Sartorius brings together multiple technologies and vast experience, with more than 1.2 million sterile connections supplied every year.
Our teams develop the layout, workflow and design of your mRNA complete process including pDNA , LNP encapsultion based on your needs.
Download the Brochure
Unlock new insights to streamline mRNA process development, product quantification, and sample characterization.
Our application note reveals how to quickly implement innovative tools for developing and maintaining robust pDNA production processes.
Watch Webinar
Learn how biopharmaceutical companies can apply proven strategies to overcome the hidden complexities in mRNA production.
Roundtable explores smart strategies to overcome challenges in mRNA process development
In part one you will learn how to achieve higher yields in the plasmid DNA by ensuring the quality and purity of the raw materials and taking other steps to optimize the production process.
In part two of the 'Your mRNA process, Simplified' webinar series, we continue to explore how improved processes, analytics, and tools can help meet the unprecedented demand for mRNA.
Part - 3: Select the Right Purification Approach for Your Process
In this final webinar of the series, Sartorius purification experts demonstrate the flexibility that can be achieved with an mRNA purification toolbox featuring monolithic chromatography.
Affinity-based chromatographic isolation is useful for mRNA production, but IVT productivity requires high oligo dT binding capacity.
Discover the steps required to purify plasmid DNA and how our solutions can improve your workflow.
IVT reactions can now produce mRNA reaching 12g/L, and our data show Hydrosart TFF cassette and Sartopore 2 offer high recovery and quality.
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