cold-chain-free-mrna-formulation-development-solutions
Are cold-chain dependencies and mRNA instability slowing your therapeutic development and increasing costs? Imagine a future where your mRNA product is stable without super-cold storage. Discover a data-driven path to thermostability.
Menu
What if you could eliminate cold-chain dependency for your mRNA therapeutic?
The High Cost of a Fragile Formulation
A Data-Driven Path to Thermostability [1]
Accelerate Your CMC with Confidence [12]
Literature
What if you could eliminate cold-chain dependency for your mRNA therapeutic?
Messenger RNA is naturally unstable, which is a big problem in drug development. This means we have to rely on an expensive and complex cold chain. [1] mRNA molecules break down easily from common enzymes and chemical reactions in water. [1] Because it's so sensitive, mRNA needs super-cold storage, often at -20°C or even -70°C, to stay whole and work right in vaccines and treatments. Any time the temperature changes, it could make the product less effective. This leads to costly delays and a lot of waste. Globally, up to 50% of vaccines are wasted each year, mostly because temperature control fails. [2] For a CMC leader, this directly means more risk, shorter timelines, and huge pressure to deliver a stable, effective product under strict rules. [3]
The High Cost of a Fragile Formulation
Your team has engineered a promising mRNA candidate, but formulation problems are holding up the IND submission. There's huge pressure to create a strong CMC plan, but repeated stability runs fail, showing clumping, weaker potency, and the breakdown of the lipid nanoparticle (LNP) delivery system. These aren't just science problems; they're big business risks that delay clinical trials and stress budgets.
Having to depend on a strict cold chain makes things even more complex and expensive. Storing and shipping temperature-sensitive biologics costs a lot, with storage alone making up over 82% of the total cost. [4] Any break in this chain, a freezer malfunction, a shipping delay, can lead to the loss of entire batches, wasting valuable resources and pushing back critical deadlines. For smaller biotechs with limited resources, these challenges can feel impossible, while even large pharma companies have trouble managing these sensitive products internally. Since mRNA is fundamentally unstable in water, old formulation methods often don't work. This leaves teams stuck, trying things over and over without a clear way forward. [5, 6]
A Data-Driven Path to Thermostability [1]
Leukocare has a smart, science-backed way to solve these problems. We design mRNA formulations that are stable in heat, so you don't need a strict cold chain, or maybe none at all. We use predictive modeling and advanced analytics. This helps us reduce risks and speed up your development.
1. Predict and De-Risk with AI-Guided Design: We begin by using our proprietary SMART Formulation® platform. It uses AI and machine learning to predict the best excipient combinations to stabilize your specific mRNA-LNP. This data-driven approach cuts down on guesswork and endless testing, which saves you time and money. By mapping out how things break down and finding key stability factors early on, we can design a formulation that's more likely to succeed.
2. Engineer for Room-Temperature Stability through Lyophilization: A main way to get rid of cold-chain dependency is lyophilization, also known as freeze-drying. This process takes out water, which is a big reason mRNA degrades, to make a stable, solid product. [1] Recent studies have shown that lyophilized mRNA-LNP vaccines can maintain their physical and chemical properties for at least 12 weeks at room temperature and for over a year at refrigerated temperatures. [1] We're experts at developing freeze-dried formulations. We also know how to pick the best cryoprotectants, like trehalose. These protect the LNPs while they dry and keep them stable for a long time. [7, 8]
3. Deliver a Scalable, IND-Ready CMC Package [9]: We don't just give you a formulation. We deliver a full, IND-ready data package that meets tough regulatory requirements. We give you solid documentation for stability protocols, analytical methods, and tech transfer. This makes sure everything goes smoothly when you scale up and start manufacturing. [10] If your team has tight deadlines, our methods to shorten formulation development timelines give you a clear edge. We focus on creating formulations that are not just stable, but also practical for big production runs. We tackle potential issues like viscosity and scalability early on. This proactive approach gives you the confidence to move your candidate into the clinic without expensive reformulation delays.
Work with us, and you can get past cold chain limits. One team successfully made their self-amplifying RNA vaccine candidate stable. It stayed stable for at least six months at room temperature after freeze-drying. This kind of stability changes everything for mRNA therapeutics in terms of logistics and cost. It makes them more accessible and affordable everywhere. [11]
Accelerate Your CMC with Confidence [12]
Get your mRNA therapeutic moving with a formulation built for stability, easy scaling, and regulatory approval. Book a call with our formulation experts. We can help you lower risks, speed up your IND submission, and stop relying on the cold chain.
Get Expert Help
IND-ready
De-risked
Scale-tested
Room-temp optimized
No guesswork
Literature
Beyond LNPs: 4 Non-Viral Delivery Vehicles Expanding The Possibilities Of mRNA Therapeutics. Life Science Connect. Published October 6, 2025.
Increasing mRNA Product Stability with Lyophilization. BioPharm International. Published February 1, 2024.
[1] Lyophilized mRNA-lipid nanoparticles vaccine with long-term stability and high antigenicity against SARS-CoV-2. bioRxiv. Published February 10, 2022.
[2] Challenges of Storage and Stability of mRNA-Based COVID-19 Vaccines. Vaccines (Basel). 2021;9(9):1033.
[13, 14] Challenges of Storage and Stability of mRNA-Based COVID-19 Vaccines. MDPI. Published September 17, 2021.
Recent Advancements in mRNA Vaccines: From Target Selection to Delivery Systems. International Journal of Molecular Sciences. 2024;25(11):5675.
Lyophilization provides long-term stability for a lipid nanoparticle-formulated nucleoside-modified mRNA vaccine. ScienceOpen. Published February 4, 2022.
Lyophilization provides long-term stability for a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine. Mol Ther. 2022;30(5):1941-1951.
[7] Addressing the Cold Reality of mRNA Vaccine Stability. J Pharm Sci. 2021;110(3):997-1001.
Cold Chain Not Required? Stabilizing mRNA-LNPs for Room Temperature Storage. Phosphorex. Published June 12, 2025.
[9] Prospects and Challenges in Developing mRNA Vaccines for Infectious Diseases and Oncogenic Viruses. Vaccines (Basel). 2024;12(6):593.
An economic evaluation of the controlled temperature chain approach for vaccine logistics: evidence from a study conducted during a meningitis A vaccine campaign in Togo. Vaccine. 2017;35(29):3633-3640.
Tip of the Iceberg: Economic and Environmental Impact of the Vaccine Cold Chain. IQVIA. Published February 3, 2024.
[4] Comprehensive Optimization of a Freeze-Drying Process Achieving Enhanced Long-Term Stability and In Vivo Performance of Lyophilized mRNA-LNPs. ACS Nano. 2024;18(42):29749-29764.
[8] Why optimized cold-chains could save a billion COVID vaccines. UNEP. Published June 26, 2020.
[3] Economic Impact of Thermostable Vaccines. Vaccine. 2017;35(18):2279-2285.
[11], [12] A self-amplifying RNA vaccine against COVID-19 with long-term room-temperature stability. Cell Rep Med. 2022;3(9):100742.
