MEPSGEN Announces U.S. Launch of NanoCalibur™ for Lab-Scale to Preclinical Nanoparticle Production

• Following a successful Korea launch, MEPSGEN brings advanced microfluidic technology to U.S. researchers
• NanoCalibur™ offers precise, scalable, and reproducible nanoparticle production for drug development
• MEPSGEN's CEO to present new technology at the 4th LNP Formulation & Process Development Summit, on April 15, in Boston.

BOSTON, April 1, 2025 /PRNewswire/ -- MEPSGEN US Inc., a global innovator in scalable nanoparticle production technology, announced today the launch of NanoCalibur™, a cutting-edge, scalable nanoparticle (NP) production system in the United States (US). Following its successful debut in Korea in Q4 2024, this platform is now available to U.S. researchers and drug developers who need reliable, simple, and scalable production of nanoparticles.

NanoCalibur™ is based on an advanced microfluidic technology that can enable the controllable, precise, and reproducible synthesis of a wide range of nanoparticle types, including lipid nanoparticles (LNPs), liposomes, lipid-polymer NPs, lipid-protein NPs, and more. Using proprietary designs, technology, and know-how, NanoCalibur™ maximizes encapsulation of NP payloads while ensuring their structural integrity and biomolecular stability.

Addressing the Growing Need for Scalable and Reproducible NP Synthesis

NPs have become a critical delivery system for mRNA vaccines, non-viral gene therapy, oligonucleotide therapeutics, chemotherapy drugs, and many other therapeutic and diagnostic agents. However, researchers often face challenges in achieving precise, controllable, and reproducible nanoparticle synthesis, particularly when preserving sensitive payloads like nucleic acids. NanoCalibur™ addresses these limitations by leveraging a patented microvortex-based mixing platform and using a closed-loop feedback control system with multiple sensors to enable continuous throughput, high efficiency, low-shear NP production. NanoCalibur™ ensures consistent and uniform formulation properties and enhanced integrity of all cargo.

The NanoCalibur™ has been shown to consistently and controllably synthesize particles with properties such as:

• Polydispersity index (PDI) of <0.1
• Encapsulation efficiencies (EEs) of >95% (incl. for mRNA)
• Hydrodynamic stability over 4 weeks, with stable sizes, PDI, and EEs
• Intact mRNA stability.

In addition, NanoCalibur™ is designed for seamless translation from discovery (Lab) to preclinical studies (GMP). With higher than 95% mixing efficiency, it can produce uniform nanoparticles with no batch-to-batch variation. Even at larger production scales, the system's controlled shear rates enable enhanced stability of mRNA and other sensitive biomolecule payloads. This makes it easier to achieve easy scale-up from lab discovery to GMP production without needing re-optimization and re-development of lab-scale synthesis protocols.

YongTae Kim, CEO of MEPSGEN, said: "We are thrilled to bring NanoCalibur™, a stable, reliable and high-precision nanoparticle synthesis platform, to the U.S. market. With its cutting-edge microfluidics technology and user-friendly design, this micro-lab makes it easier for researchers to focus on their mission to develop the next generation of nanoparticle-based therapeutics."

As part of MEPSGEN's continued expansion in the U.S. market, CEO YongTae Kim will be presenting at the 4th LNP Formulation & Process Development Summit in Boston (April 14-16, 2025), along with the opportunity to showcase NanoCalibur™

Presentation details:

• Date & time: April 15^th, at 4:30 pm ET
• Session: Track C- Process Development & Manufacturing
• Session title: Accelerating LNP Production with Optimized Process & Advanced manufacturing Strategies
• Presentation title: Parallelization of microvortex mixers enables scalable manufacturing of mRNA-LNPs while preventing mRNAs from being truncated under controlled shear rates.

About MEPSGEN

MEPSGEN is a biotech company headquartered in Seoul, South Korea, with offices in Cambridge, MA, and San Jose, CA. The company was co-founded in 2019 by current CEO YongTae Kim and Professor Robert Langer from MIT, a world-renowned expert in drug delivery and biomaterials who has pioneered numerous breakthroughs in controlled-release systems.

The company specializes in scalable NP synthesis systems, leveraging cutting-edge microfluidic technologies to support drug discovery, preclinical research, and GMP manufacturing. In addition to its NP platform, MEPSGEN also offers an organ-on-a-chip platform, expanding its innovative approach to drug development and personalized medicine. With a commitment to innovation and scientific excellence, MEPSGEN empowers researchers worldwide to advance nanoparticle-based therapeutics and precision medicine.

For more information, please visit www.mepsgen.com.

SOURCE MEPSGEN