With all the setbacks and frustrations of the COVID-19 pandemic, one positive development was the production of several vaccines using mRNA (Messenger Ribonucleic Acid) technology.
In contrast to conventional vaccines that introduce a weakened or inactivated virus, mRNA vaccines deliver messenger RNA—a fundamental molecule present in every cell. Messenger RNA is a key to protein synthesis and gene expression; whereas RNA converts genetic information from DNA, mRNA copies the genetic blueprint and carries it over for protein production. Thus, mRNA is the key molecule to enable protein synthesis, such as the production of antigens.
mRNA vaccine formulations work by utilizing these harmless antigens, introduced to the body by the vaccine, to trigger a natural immune response and produce specific antibodies against the virus.
Although new to the general population, mRNA technology had been studied for decades in an effort to provide cures to many diseases which had been plaguing the world for years. However, when the COVID-19 pandemic hit, the scientific community shifted gears and collectively searched for and developed new vaccines at record speed.
Aided by not only mRNA technology but virtually unlimited global financial resources, government support and unified, global talent, viable mRNA vaccines were not only achieved in record time but were also able to meet the rigorous standards of the United States Food and Drug Administration (FDA) and achieve full approval.1
With mRNA vaccine production, the medical community has benefited from a new and safe vehicle to find solutions to problems that have existed with little gain. This new technique has now provided opportunities to ignite real progress in discoveries for new clinical trials and vaccines and are progressing quickly.
According to Penn Medicine News, mRNA pioneer Dr. Drew Weissman believes, “Outside of infectious diseases, mRNA technology could be the future of protein replacement therapies, immuno-therapeutics, cancer treatments, personalized cancer vaccines, genetic diseases, and other drug development.”2
In the field of vaccines, new developments are currently being made using this same COVID-19 blueprint. Since the COVID-19 outbreak, a patent has been filed for a new malaria vaccine for researchers at Yale University using RNA technology.
Guided by the model used for the COVID-19 vaccine, the malaria vaccine is being developed to achieve long-term immune protection from the Plasmodium Macrophage Migration Inhibitory Factor (PMIF) protein.3 The University of Illinois, Chicago has also been making progress in mRNA vaccine production for dengue fever. And despite over three decades of research, HIV has eluded a vaccine. However, as of March 2022, a Phase 1 study began to examine mRNA technology for HIV and evaluate three experimental HIV vaccines.4-5
Prior to Covid-19, Pfizer and BioNTech had been working on an mRNA vaccine for seasonal influenza. Previously, researchers struggled because multiple variants of the flu are factors during any given season. Before mRNA vaccine formulation, the challenge was selecting the strain that was either most probable or presented the largest health risk. Using mRNA technology may now allow the ability to modify the flu vaccine quickly once the seasonal variant has been identified.6
In the field of cancer, instead of using mRNA to elicit an immune response against a foreign protein, the technology is being used to make the body’s own cancer cells identifiable to the immune system. Throughout the research community, mRNA technology had been studied long before the pandemic for potential general and personal treatment plans. Dozens of clinical trials are now underway in which mRNA instructs a patient’s cells to produce protein based on a tumor’s genetic mutations which then prompts the immune system to find other mutated cancerous cells, as well as tumor cells, and attack them.7
In the field of gene therapy for genetic and inherited diseases, which affect small numbers, there is new hope with possible treatments and trials. Unlike vaccines which use mRNA for protection against a virus, gene therapy uses mRNA’s gene-editing ability to target abnormal areas of gene sequences that need to be deleted or corrected. One such example is amyloidosis, "a rare disease that occurs when an abnormal protein, called the amyloid, builds up in the organs and interferes with their normal function.”8
Previously, there was no cure and only limited treatment for this disease. Now, for familial transthyretin amyloidosis, a genetic or inherited type of amyloidosis, in conjunction with CRISPR technology, mRNA is being used to deliver gene-editing instructions to the liver, thus shutting down the production of the abnormal transthyretin (TTR) protein.9
With all the accomplishments that lie ahead for mRNA vaccine production, these achievements would not be possible if not for the key component of lipid nanoparticles (LNPs). Lipid nanoparticles are recognized as a superior drug delivery platform for delivering nucleic acids, DNA and RNA.
Composed of a layer of fat, LNPs offer flexibility and protection to their payload. Since both LNPs and cell membrane structures are similar, LNPs are accepted as transport carriers into cells where they can then release their payload safely. Previously, mRNA did not have an effective vehicle to enter the body or reach its destination.
Now, mRNA has been revolutionized to deliver its payload and achieve success when used in conjunction with lipid nanoparticles. LNPs are the superior complement that allows mRNA to travel to their targeted area intact. Without lipid nanoparticle technology, the existence and success of mRNA vaccines would simply cease to exist.
Microfluidizer® technology is a proven method for achieving superior, solvent-free lipid nanoparticles.
Our processors achieve LNPs with controlled particle sizes and narrow distributions for increased product stability and improved downstream process by delivering consistent, high shear forces. Through Microfluidics’ unique Interaction Chamber™, the material is exposed to extreme shear rates thereby requiring fewer passes to achieve particle size reduction. This efficient processing provides a benefit in both time and cost.
Our proven solvent-free method eliminates the complicated process of solvent removal which not only saves time and money, in the production process but also makes it environmentally friendly.
Our unique top-down technology can conform to cGMP regulations which is critical for pharmaceutical and biotechnology production. Microfluidics offers a full range of lab-scale, pilot-scale and production-scale processors which have been used by top pharmaceutical companies for decades. Our team of engineers are knowledgeable in the design, materials, and sanitary requirements needed to meet all government cGMP regulations.
Microfluidizer® technology is linearly scalable for consistent, repeatable results from research and development to production scale volumes. Not only can results be duplicated batch-to-batch but, through Microfluidics’ revolutionary Interaction Chamber™ system, they can also be easily replicated from benchtop results to global distribution. Thereby, as mRNA technology continues to achieve success in research and development, these successes can be easily implemented to production scale to reach their true potential.
Microfluidics™, the manufacturer of Microfluidizer® high shear fluid processors, is a leader in the design and production of laboratory and commercial processing equipment for nano-scale material. Through superior lipid nanoparticle production, Microfluidics can help achieve the next mRNA breakthrough.
The TAMARA nanoparticle formulation system is a bottom-up solution for mRNA vaccine production from Inside Therapeutics, brought to the USA & Canada by Microfluidics™.
This benchtop system offers a seamless, scalable solution for creating lipid nanoparticles (LNPs) essential to mRNA vaccine formulation. By supporting the entire R&D process—from low-volume screening of just 200µL up to in-vivo scale 30mL batches—TAMARA enables researchers to progress smoothly from early-stage development through to production without needing to change equipment. Leveraging precision microfluidic technology, the system synthesizes high-quality nanoparticles, such as LNPs, for consistent, controlled mRNA encapsulation and rapid optimization across a wide range of formulations.
Key benefits of the TAMARA system include its ability to achieve over 95% encapsulation efficiency of RNA into LNPs, ensuring robust delivery of the mRNA payload for vaccines. It offers rapid sample processing—completing runs in under two minutes and allowing for high-throughput screening of over 20 formulations per hour. The system’s reusable microfluidic chips and reservoirs also promote sustainability and cost efficiency, making it a practical solution for fast-paced mRNA vaccine production environments.
As mRNA vaccine formulation continues to evolve, TAMARA’s advanced capabilities provide manufacturers and researchers with the flexibility, efficiency, and precision required to accelerate therapeutic and vaccine development.