mRNA Vaccines

In the face of a global pandemic, the pressure has never been greater to bring an effective and safe vaccine to market as quickly as possible – but the level of inspiration and openness to collaboration is equally great. The solution we are looking for may reside in one of the newest platform technologies, mRNA vaccines. A promising alternative to manufacturing proteins as a basis for an antibody treatment, this technology is based on mRNA encoding antigen genes of an infectious agent and inducing an innate immune response.


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What Are mRNA Vaccines?

mRNA vaccines are a very promising modality of the vaccine industry and are garnering a lot of attention. They are non-infectious, non-integrating, cell-free, and offer both rapid and readily scalable production with high productivity. mRNA vaccines are a true platform: the same process can be used to produce mRNA vaccines against different indications. The appeal of the safety profile and being one of the fastest and most flexible development strategies is undeniable – but being a new technology, the platform is evolving, and process parameters are rapidly changing.

How mRNA Vaccines Can Serve the Industry, Including the Pandemic Response?

mRNA have the potential to revolutionize the vaccine industry and hold a promising pipeline ranging from cancer application to indications with unmet needs such as HIV or Zika. In the face of the global COVID-19 pandemic, the pressure has never been greater to bring an effective and safe vaccine to market as quickly as possible – but the level of inspiration and openness to collaboration is equally great. mRNA vaccines have gained visibility during the crisis as this strategy has been able to bring the first vaccine candidate to clinics at an unprecedented speed.

The Promise of DNA Vaccines

The field of DNA vaccination has been evolving rapidly during the past decades. DNA vaccines consist of DNA plasmids that are taken up by the cells and can be translated into a protein antigen, hence inducing an immune response. They are easy and relatively cheap to produce, stable, safe in handling, and induce both cellular and humoral immune response.


The Manufacturing Process for mRNA Vaccines

We invite you to discover the Sartorius toolbox of technologies, dedicated to the production and purification of plasmid DNA and mRNA. Please click on each step to learn more about the individual process step.

Plasmid DNA can be used for two applications within the vaccine industry: DNA vaccine as a raw material for mRNA vaccines. Plasmid manufacturing, which can be in-house or a sub-contract to a third party, is a fermentation process based on production of DNA plasmid in E.coli followed by purification.

Plasmid DNA

Plasmid Production

Plasmid Purification

mRNA Vaccines Are Cell-Free Processes

mRNA Production

Lipid NanoParticle (LNP) Production

Other Technologies

Need

Solution

Quality by Design (QbD) relies on DoE to understand critical process parameters, which is dependent on implementing many experiments – a tool that can help design and plan experiments alleviates the burden

Performance Analytical Technology generates a lot of data that is difficult to analyze, resulting in significant demand for a tool to evaluate historical data in order to identify correlations, do troubleshooting and gain process understanding  

Most vaccine developers and manufacturers are not statisticians and rely on user-friendly interfaces and software

The Umetrics® suite include three user-friendly and intuitive software designed for process developers and manufacturers to support data analytics through unique data visualization, extensive wizard functionality, and customizable plots to maximize usability and versatility:

  • MODDE® is an advanced, high-quality DOE solution designed for ease of use. The benefit of DOE is to gain knowledge and estimate the best-operating conditions of a process or product, and with MODDE ® the graphical interface and analytics support make it easy to interpret results with complete confidence  
  • SIMCA® Multivariate Data Analysis (MVDA) software is used for scale and batch-to-batch comparison investigations. SIMCA transforms data into visual information for easy interpretation, enabling decisions and actions to be taken rapidly and with confidence. SIMCA helps to analyze process variations, identify critical parameters and predict final product quality. An overview of the process status can be obtained in a few clicks  
  • SIMCA®-online is a highly efficient software for real-time multivariate statistical process monitoring & control. SIMCA-online provides a complete set of interactive and visual monitoring tools to production teams, to ensure that batch and continuous operations run smoothly

These software options are fully integrated in most Sartorius systems and are available as stand-alone programs.


Resources

Can mRNA Disrupt The Biopharma Industry?

PDF | 128.3 KB

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