Raman Spectroscopy for Testing Stability of RNA-based Vaccines and Drugs

Background:

The development of mRNA-based vaccines for COVID-19 offers the potential for a new medical paradigm based on RNA technology. Unfortunately, these drugs require unique storage conditions to keep the RNA stable. Manufacturers recommend storing vaccines at ultralow temperatures ranging from -80 to -20°C. As a result, nearly half of the vaccines distributed worldwide have been wasted due to improper thermal control. It is therefore critical to assess mRNA degradation in mRNA vaccines and therapeutics. However, current methods that require special reagents and labels can be destructive and are time-consuming. Better methods for probing mRNA degradation in solutions could significantly reduce the amount of wasted vaccines by assuring mRNA integrity. In addition, pharmaceutical companies are investing more in RNA-based therapeutics, increasing the need for testing methods that can be performed both as quality assurance and during drug development. Drug and biotechnology companies are racing with each other to develop solutions to the mRNA degradation and storage problem. 

Technology Overview:

This technology uses Deep-UV Resonance Raman (DUVRR) spectroscopy to probe the integrity of mRNA in mRNA vaccines. DUVRR spectroscopy’s potential to assess RNA integrity is based on its ability to selectively probe the nitrogenous bases while eliminating interference from the lipids, focusing the analysis on structural changes to the bases only.  The resonance effect used in this technique provides higher sensitivity to probe these mRNA molecules at lower concentrations than in the case of non-resonance Raman. In addition, the inherent specificity of the Raman signal to probe the vibrational fingerprint of the bases allows for label-free detection. This method also shows general applicability to probe integrity of mRNA and other nucleotide-based materials for other purposes and applications. As the race for thermally stable mRNAs proceeds this technology offers a much quicker and more economical approach to testing different approaches to stabilizing RNA vaccines and therapeutics. 

Advantages:

•    Direct and more efficient than current mRNA assessment methods.
•    Less expensive.
•    Non-destructive.
•    Fast and reliable. 

Applications:

This tool can be leveraged of faster and more economical testing of approaches to create more stable mRNAs. Where the state of the art requires the expression of mRNAs to test their viability, this approach allows for nondestructive and real-time analysis of RNA viability. Additionally, this technology could be developed for retail applications to allow pharmacies to ensure mRNA viability in the case of a power failure or other disturbance to storage conditions.

Intellectual Property Summary:

Patent Application Filed 1/13/2023.  Application No. 63/438,968. 

Stage of Development:

TRL 3 - Experimental proof of concept

Licensing Status:

This technology is available for licensing.

Licensing Potential:

This technology would be of interest to anyone involved in the development of mRNA vaccines and therapeutics, including:
•    Pharmaceutical manufacturers.
•    Hospitals.
•    Health care providers.
•    Universities.
•    Medical research laboratories.