Shin Etsu Chemical Co. (Tokyo) and Hokkaido University (Sapporo) have introduced a novel lipid nanoparticle (LNP) production system that integrates a microfluidic device, one that features channels only a few micrometers to several hundred micrometers wide. This new system, scheduled for manufacturing by Shin Etsu Chemical in April 2025, will be distributed by Lilac Pharma Inc., based in Hokkaido.

LNPs, which measure between 10 and 1,000 nanometers in diameter, are composed mainly of lipids and have gained prominence with their use in mRNA COVID 19 vaccines. Experts expect LNPs to be instrumental in developing vaccines for infectious diseases and cancer in the coming years. In recent years, both domestic and international research communities have taken a closer look at production methods that employ microfluidic devices to create these nanoparticles.

Traditionally, LNPs are formed when lipid and nucleic acid precursor solutions mix rapidly. The incorporation of a microfluidic device into this process allows for exceptional control over the resulting particle size compared to conventional manufacturing techniques. Although this method produces LNPs with greater precision, it has historically been limited by low productivity—the technology was confined to producing small batches of particles. In response, the partners combined Hokkaido University’s proprietary iLiNP microfluidic technology with Shin Etsu Chemical’s processing capabilities and synthetic quartz materials. The result is a microfluidic device suitable for large-scale production.

Adding to the breakthrough, Shin Etsu Engineering, a subsidiary of Shin Etsu Chemical, contributed its system design expertise to develop a full LNP production system that meets GMP requirements for pharmaceutical manufacturing. One of the key advantages of this new system is its flexibility: it can adjust production volumes based on demand. Occupying only a single square meter of space, the system is versatile enough to manufacture a range of LNP products—from small batches tailored for personalized nanomedicine to mass-produced vaccines intended for widespread infectious disease control.

Looking ahead, the developers aim to establish the system as a foundational infrastructure that can meet routine corporate nanomedicine production needs and pivot rapidly to vaccine manufacturing during pandemics. In parallel, the Shin Etsu Chemical and Hokkaido University research teams are working on an even more compact, benchtop version of the LNP production system. They expect to complete a prototype by the end of 2025, paving the way for a seamless transition from research and development to full-scale manufacturing.

With this innovative lineup of LNP production systems—ranging from a research prototype to a system capable of mass production—Shin Etsu Chemical and its partners are setting the stage for agile manufacturing in both everyday applications and emergency pandemic responses. The companies remain committed to leveraging their technological expertise to support industrial development and advance a sustainable society, while meeting the evolving needs of the healthcare market.