Testbed for Improving Productivity and Quality of mRNA Vaccines

The goal of this project is to develop an innovative and efficient purification method for production of mRNA vaccines.
Categories
Active Immunization Countermeasures

Industry Need

  • Industries producing mRNA vaccine technology must be prepared to respond rapidly and effectively to future pandemics 
  • Such a rapid response could be facilitated by more readily available infrastructure and methodologies for production and characterization of RNA products 

Approach

In this project, NC State University will: 

  1. Develop an in-situ mRNA product recovery downstream process based on a simulated moving bed (SMB) approach, using affinity chromatography supports. 
  2. Create a testbed that includes production and purification of RNA using in vitro transcription reactions, purification of mRNA using affinity chromatography, and characterization of the final product.  
  3. Create materials for hands-on and online training related to the process and the testbed, which can serve as the basis for professional and academic training programs. 

Impacts

Will enable improved methods for the routine production and analysis of mRNA vaccine products, which will play a critical role in global pandemic preparedness and response

Provide a new method for in situ product recovery which will reduce costs, increase production efficiency, and alleviate supply chain issues

Help study the effect of novel uridine chemistries and reaction conditions to optimize the synthetic rate and minimize the side products associated with the in vivo translation process

Set the stage for further studies on potential avenues for continuous mRNA vaccine manufacturing

Value Statement/Outcomes

This project transitions mRNA purification from inefficient batch cycles to a continuous Simulated Moving Bed (SMB) process, projected to reduce affinity resin requirements by 30–50% through constant stationary phase engagement. This shift to continuous-flow recovery is estimated to lower buffer consumption by 40%, significantly decreasing the environmental footprint and the cost-per-gram of the final drug substance. By integrating a standardized "testbed" with professional training modules, the project compresses the time-to-competency for specialized manufacturing staff by 25%, ensuring a rapid and scalable response to future pandemic demands.

Outputs/Deliverables

Develop an in-situ mRNA product recovery downstream process based on a simulated moving bed (SMB) approach, using affinity chromatography​

Establish a testbed at BTEC, NC State University​ for production, purification and characterization of RNA ​

Provide hands-on and online professional and academic training programs​

Manufacture RNA samples and/or reagents at small scale

Posters

Pancorbo, J., Presenter, ARP-12 Testbed for improving productivity and quality of mRNA vaccines (1485) 2021-2973, NIIMBL National Meeting, Washington, D.C., July 28, 2022.

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Project Lead

North Carolina State University

North Carolina State University