This is the fifth blog post in the Biopharmaceutical Basics series.
About 30 years ago, scientists began exploring whether vaccines could be made more simply. Instead of injecting a weakened virus, or a piece of the virus’s protein coat, they tried an alternative approach. Instead of injecting a piece of the virus into the body, they explored the idea of causing the body’s cells to make that piece of the virus. This approach also would educate the immune system to recognize the virus.
Ultimately, this work led to the introduction of messenger RNA (mRNA) vaccines.
If you’re new to the world of biopharma analysis, here’s a helpful overview on mRNA-based therapeutics and vaccines and what technologies are available today to support mRNA work.
What are mRNA-based therapeutics and vaccines?
mRNAs enable the body to make the proteins we need to prevent, treat or cure diseases. Unlike traditional biologics, mRNAs are large and delicate molecules that are produced using in vitro transcription (IVT), which need to be protected by lipid nanoparticles (LNPs) before they reach target cells. Analytical characterization of mRNA therapeutics presents unique challenges that require new technologies and solutions.
How do mRNA vaccines work?
mRNA vaccines work by introducing an mRNA sequence coded for a disease specific antigen. Once produced within the body, the antigen is recognized by the immune system, preparing it to fight the virus if presented. Because mRNA is transient in the body, synthetic mRNA products require modifications to protect the mRNA from natural degradation.
How is mRNA manufactured and delivered?
mRNA is produced using a DNA plasmid template in a process called in vitro transcription (IVT). Because of the transient nature of mRNA, focus is on properly modifying mRNA and the delivery vehicle for the product to survive the body’s natural defenses. Lipid nano particles (LNPs) are currently the most used delivery systems.
For mRNA-based vaccines and therapeutics to be acceptable to regulatory agencies, in-depth analytical characterization and accurate monitoring of critical quality attributes (CQAs) of both mRNA and LNP are needed to ensure safety and efficacy. This means impurities need to be understood through characterization, acceptable levels defined, and then monitored for safety and efficacy.
What are some benefits of mRNA technology?
One of the most exciting aspects of mRNA technology is how rapidly it can be developed to target a particular virus. While traditional vaccines can take years, creating an mRNA-based vaccine that targets a newly discovered virus can be accomplished in a short period of time (days to weeks to make the new vaccine candidate) and primarily requires knowledge of the viral genetic code. This greatly speeds up vaccine development.
What solutions are offered?
Thermo Fisher Scientific is your trusted partner to support your analysis at every stage — from R&D to QA/QC. We offer comprehensive solutions for characterization, confirmation and monitoring of your mRNA therapeutics and vaccines. Our solutions ensure high-quality results with speed at every stage of the development process – from discovery to commercial production – so that you can go to market quickly and confidently.
To learn more, contact us or visit our dedicated mRNA website.
We also encourage you to join our AnalyteGuru community and Forum to stay informed when new biopharma and gene therapy topics are released.
Additional resources in the Biopharmaceutical Basics blog series
Biopharmaceutical Characterization: A Biopharmaceutical Basics Overview
Multi-Attribute Method (MAM): A Biopharmaceutical Basics Overview
Gene Therapy: A Biopharmaceutical Basics Overview
Oligonucleotide Therapeutics: A Biopharmaceutical Basics Overview