[Edaily Reporter Kim Jinsoo ] Following the application of the messenger RNA (mRNA) concept to COVID-19 vaccines—which have already been commercialized—and the emergence of results from a completely new type of “cancer vaccine,” attention is now focusing on lipid nanoparticle (LNP) technology, which delivers mRNA into the body. Since LNP technology is essential for mRNA product development, the LNP market is expected to grow as expectations for mRNA rise.

mRNA is a substance that contains genetic information for producing specific proteins. However, because it is large and hydrophilic, it cannot pass through cell membranes. Therefore, if mRNA is administered as is, there is a high likelihood it will be lost before reaching the target cells; even if it enters the cell, it cannot reach the cytoplasm—where protein synthesis occurs—and thus cannot produce the desired effect.

This is where LNPs come into play. LNPs encapsulate mRNA in a lipid shell, protecting it from external enzymes and physical and chemical environments, and helping cells absorb the particles. Once inside the cell, they facilitate the mRNA’s journey to the cytoplasm. The mRNA’s nucleotide sequence determines the therapeutic effect, while the LNP serves as the carrier for this substance.

Lipids regulate the escape of encapsulated mRNA from endosomes; phospholipids and cholesterol control particle structure and stability; and PEG-lipids regulate particle size, aggregation, and in vivo behavior. While LNPs are not the only method for mRNA delivery, they are the most prominent approach because they represent a clinically validated method of in vivo delivery.

The greatest challenge in the commercialization of LNPs is achieving uniform particle size during mass production. LNPs are formed through the rapid mixing of an organic solvent containing dissolved lipids with an aqueous solution containing mRNA; even slight variations in flow rate, flow rate ratio, mixing time, temperature, pressure, or shear stress can alter particle size and distribution, as well as the mRNA encapsulation efficiency.

Increasing the flow rate or widening the flow path to boost throughput during LNP production alters the mixing conditions and shear stress. Consequently, particles may become non-uniform or the mRNA may be damaged, making it difficult to replicate the efficacy observed in the research phase during mass production.

According to a report by Research and Markets, the global LNP manufacturing market was valued at $976.8 million (approximately 1.4 trillion won) in 2025. With the expansion of mRNA therapeutics and advancements in drug delivery technologies, the market is projected to reach $2.77 billion (approximately 4 trillion won) by 2035. The compound annual growth rate (CAGR) during this period is expected to reach 11%.

In South Korea, Inventage Lab Inc. ( Inventage Lab Inc.(389470)) and Mepsgen possess proprietary LNP manufacturing technologies and have advanced to the actual commercialization stage. Both companies share the commonality of having solved the issues of reproducibility and scale-up in LNP manufacturing through microfluidic technology. Among them, Inventage Lab Inc. excels in an “integrated process specialized for nucleic acid drugs,” which spans from LNP formulation to stabilization and concentration, as well as GMP production and CDMO services.

Mepsgen simultaneously addresses “drug stability, production scalability, and formulation versatility” through low shear rates, channel parallelization, and interchangeable chips. A key feature is the broad market applicability of its equipment, as it is not limited to LNPs but can also handle nanoparticles and microparticles for long-acting injectables.

Inventage Lab Inc.: Connecting the Entire LNP Process with CDMO

Inventage Lab Inc. possesses its proprietary LNP manufacturing platform, “IVL-JinFluidic.” The company has applied the microfluidic process and equipment design expertise it acquired during the development of long-acting injectables to LNP production. The core of this technology lies in precisely controlling the mixing conditions of nucleic acids and lipids to consistently produce uniform particles, and in bridging the manufacturing conditions established during the research phase to clinical and commercial production.

The “HandyGen” series features equipment incorporating IVL-JinFluidic technology. The lineup includes HandyGen Lab for research, HandyGen GMP for clinical sample production, and HandyGen Commercial for commercial production. Inventage Lab Inc. extends its services beyond equipment sales and leasing to include LNP contract development and manufacturing (CDMO) services, covering formulation optimization, process development, and clinical sample production. The company has signed a joint LNP CDMO commercialization agreement with EuBiologics Co., Ltd. and plans to expand its GMP production infrastructure by installing the HandyGen system at Quratis Inc.’s Osong plant.

The strength of IVL-GenFluidic lies in its ability to consistently apply the same process from the research stage through commercial production. This method involves lowering the solvent concentration immediately after LNP formation to rapidly stabilize the particles, thereby minimizing changes in particle size and uniformity even as the scale is increased. In fact, Inventage Lab Inc. confirmed at the 2026 Conference on Drug Delivery Science (CRS) that particle characteristics and biological activity were maintained even when scaling up from research to commercial-scale HandyGen production for linear mRNA, self-amplifying mRNA, and circular mRNA. The production yield reaches up to 89%.

Another strength is that the technology has already been validated in real-world settings through participation in numerous government-funded projects. Following the Ministry of Trade, Industry and Energy’s project to develop an mRNA vaccine formulation and mass production system, Inventage Lab Inc. is currently participating in the Korean ARPA-H project titled “Establishment of a Decentralized Vaccine Production System.” Inventage Lab Inc. is responsible for developing the mass production process and equipment for high-quality LNP vaccines. The company is also leading an approximately 8.5 billion won project funded by the Ministry of Trade, Industry and Energy that utilizes AI to automatically optimize LNP formulations and manufacturing conditions.

An Inventage Lab Inc. official stated, “We plan to expand not only domestic commercialization but also technology transfer, and we intend to continue pursuing collaborations with global pharmaceutical companies.”

Mepsgen Bets on Chip Parallelization

Mepsgen owns the “NanoCaliber

,

” an automated particle manufacturing platform. NanoCaliber uses proprietary microfluidic and micro-vortex technologies to produce not only LNPs but also lipid-polymer nanoparticles, polymer nanoparticles, and microparticles. Since the microfluidic chip is swapped out according to the target particle, a single piece of equipment can be used for various drug delivery systems (DDS).

The key differentiator is shear rate control. If the flow rate is set too high to increase LNP production, the resulting high shear force can affect the structure and function of sensitive substances such as mRNA; however, Mepsgen has designed its microfluidic chips to ensure high mixing efficiency while remaining within the permissible shear rate range for each drug.

The scale-up method is also different. Rather than forcing more fluid into a single channel, production volume can be increased by arranging multiple microfluidic channels—the same ones used in research equipment—in parallel. Theoretically, since the flow rate and mixing conditions of each channel can be maintained, there is little need to completely redesign the process even as production scale increases.

The NanoCaliber series consists of the Mini model for initial screening, the Lab model for process development, the Pro model for high-volume production, and models for clinical and GMP production. The company expanded its product lineup by sequentially launching the Lab model in 2024, followed by the GMP model in 2025 and the Pro model in 2026.

Mepsgen is targeting the global market with a focus on equipment sales. The company established Mepsgenus, a subsidiary in the U.S., and is conducting evaluations and demonstrations for pharmaceutical companies, biotech firms, universities, research institutions, and CDMOs, using Boston and Silicon Valley as its bases. This year, the company unveiled the “NanoCaliber Pro” and held individual meetings with global pharmaceutical companies such as Johnson & Johnson and Eli Lilly.

A Mepsgen official stated, “In Japan, we are expanding discussions on the adoption of NanoCaliber with universities and pharmaceutical companies through our local partner,” adding, “We aim to establish ourselves as an integrated DDS manufacturing platform that goes beyond simple research equipment to connect everything from early-stage formulation research in new drug development to process development, scale-up, and GMP production.”