Our Commitment to Innovative Approaches to Delivery
For over ten years, Moderna has worked at the intersection of science, technology and health, advancing mRNA technology to reimagine how medicines are made. mRNA carries instructions for the body to make a specific protein, and these instructions are like a “blueprint.” Once these instructions are delivered to the cells, the cell then puts the protein together.¹ A critical and sometimes overlooked piece of the puzzle is developing and improving delivery methods – or how those mRNA medicines are dispatched for the prevention or treatment of diseases.
Our commitment to developing innovative approaches to delivery can be seen through several examples, and the first is core to Moderna’s history.
Lipid Nanoparticles:
Multiple biological barriers must be overcome to deliver mRNA medicines and maximize their clinical potential. In most cases, mRNA-based medicines are most effectively delivered by encapsulating the mRNA in tiny lipid (fat) droplets, known as lipid nanoparticles (LNPs) to protect it against degradation and facilitate uptake by cells.² Moderna has developed numerous proprietary LNPs in the past 10 years, each suited to target different cell types and optimized for different routes of administration. We have also invested in the development of LNPs for systemic, intramuscular, intratumoral, and pulmonary delivery of mRNA. Double-clicking on one of those is another great example of innovative approaches to delivery.
Inhaled Pulmonary Therapeutics:
With Moderna's focus on respiratory diseases, we are also working to design mRNA delivery systems tailored to targeting pulmonary disease. In this scenario, delivering mRNA medicines directly to the lungs through inhalation could be a preferred method of administration to maximize the concentration of the medicine locally in the lung. Embracing the opportunity to innovate, Moderna is researching and developing an LNP formulation could address many of the challenges associated with lung delivery of mRNA. This pulmonary LNP formulation is delivered by inhalation, uses multiple lipids, and may be able to target specific areas of the lung. It is currently being studied in a Phase 1 trial from Vertex, evaluating the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.³
Pre-Filled Syringe (PFS):
While Moderna didn’t invent the pre-filled syringe, the company sees it as a vital tool for optimizing the delivery of mRNA. Vaccine formulations are available as single- or multi-dose vials, in fluid form or lyophilized powder that require reconstitution, and more conveniently as a PFS.
PFS are convenient devices for the delivery of parenteral medications, with a ready-to-use formulation. During the pandemic, Moderna’s vaccines first became available as frozen vial. Today, they are now available as a PFS. The advantages of PFS over traditional needle and vial delivery systems have been well-documented. PFS are easy to use, ensure accurate dosing, and reduce waste⁴,⁵.
We are working toward our mission of impacting as many people as possible with mRNA medicines. As part of staying agile, we are committed to constantly evolving our approach to delivery, either through creating our own approaches or leveraging existing tools in new and innovative ways.
¹https://www.modernatx.com/en-US/power-of-mrna/science-of-mrna
²https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9250827/
³https://www.clinicaltrials.gov/study/NCT05668741?cond=Cystic%20Fibrosis&term=VX-522&rank=1
⁴https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595078/
⁵https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8700297/