Processing challenges in realizing the future potential of mRNA vaccines and therapeutics
Messenger RNA (mRNA) is a critical component of cellular gene expression, as it instructs cells to create particular proteins. This function can be exploited for vaccines by using mRNA to teach cells to craft a protein characteristic of the virus or bacteria that is being vaccinated against, such as the spike protein of SARS-CoV-2. Likewise, mRNA can instruct cells to make an endogenous protein to compensate for a protein that is missing or defective, thereby treating the illness caused by the lack of or defect in that protein.
With the success of mRNA vaccines on the proving ground of the COVID-19 pandemic, the potential of mRNA vaccines and therapeutics is more apparent than ever. Some of this potential comes from the fact that the mRNA pharmaceutical manufacturing process is simpler, more robust and more scalable than other biotherapeutics.
Despite the relative simplicity of mRNA manufacturing, issues in the supply chain and in mRNA workflows limit the biopharma industry’s ability to take full advantage of mRNA’s potential. Opportunities for improvement exist in:
- Supply chain stability, reach and redundancy,
- In vitro transcription process optimization,
- Improvement of chromatography resins, and
- Closed fluid handling systems
A globally integrated supply chain and support from process experts will be crucial to solving challenges across the mRNA workflow to meet demand for mRNA biopharmaceuticals in the coming years.
Jonathan Fura and Navjot Kaur provide insight into pain points in mRNA manufacturing and into the solutions that can evolve through the supplier-manufacturer relationship.
Authors
Dr. Jonathan Fura
Manager, Research & Development
In his current role, Jonathan focuses on developing technologies that are utilized to advance the development and manufacturing of antibody-based biopharmaceuticals and diagnostics. Jonathan holds a Ph.D. in chemistry with a focus on developing immunomodulation therapeutic strategies.
Dr. Navjot Kaur
Business Segment Manager, mRNA and Gene Therapy workflows
Navjot specializes in mRNA and gene therapy workflows to provide solutions in the biomanufacturing of mRNA vaccines and therapeutics. She has a Ph.D. in Biology and twenty-plus years of experience in biopharma/biotechnology spanning from automation in early discovery to synergizing workflows for commercial production.