Messenger RNA (mRNA)-based technology has emerged as a highly versatile platform for the development of advanced medicines and precision therapies, thanks to its speed of design and production, as well as its adaptability to different diseases, from emerging infections to pathologies of genetic origin or cancer.
However, these medicines present significant challenges in manufacturing and quality control, due to the fragility of RNA and the complexity of the synthesis, purification, and formulation processes. For this reason, it is key to develop robust control systems and advanced analytical methods to guarantee the quality, safety, and efficacy of mRNA-based products.
IQS and the company HIPRA Scientific collaborate in the TECARN project, which aims to develop and validate advanced analytical methodologies to analyze and characterize mRNA. The project is funded within the Academia-Industry collaboration call Nuclis R+D Projects (20204) by ACCIÓ – Generalitat de Catalunya.
Participating in the project on behalf of IQS are Dr. Cristina Fornaguera Puigvert, coordinator of the NanoTher-Nanotherapies Lab and with experience in developing mRNA-based vaccines, and Dr. Gemma Gotor Navarra, researcher at the Department of Applied Analytical Chemistry and head of the Chromatography Laboratory (GMP).
The project focuses on the development of analytical methods to evaluate the purity, content, and structural integrity of messenger RNA, thus ensuring its quality as an “active ingredient”
IQS brings to the project its expertise in the development of analytical methodologies based on liquid chromatography coupled to mass spectrometry. HIPRA, for its part, will provide the necessary samples to carry out the analytical developments and, once completed, the transfer of the analytical methods will be carried out with the goal that HIPRA can implement them in the quality control of its production.
The TECARN project reinforces the collaboration between university and company and contributes to positioning Catalonia as a benchmark hub in biomedical research and pharmaceutical innovation. In this context, it promotes the development of new analytical methodologies based on mass spectrometry for the characterization of messenger RNA, taking advantage of the separation capacity of liquid chromatography, and subsequently making them available to the pharmaceutical industry (in this case, the company HIPRA) to facilitate progress in the development of new mRNA-based therapies.
Overall, TECARN represents a key step towards the improvement and harmonization of messenger RNA quality control, an essential element for the safe and effective development of the next generation of vaccines.
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