Shin-Etsu Chemical Co., Ltd. (Head Office: Tokyo; President: Yasuhiko Saitoh; hereinafter, "Shin-Etsu Chemical") and Hokkaido University (Location: Hokkaido; President: Kiyohiro Houkin; hereinafter, "Hokkaido University") have developed system for the production of lipid nanoparticles (LNPs) that incorporates a microfluidic device as a component. Shin-Etsu Chemical will begin manufacturing this production system in April 2025, with Lilac pharma Inc. (Head Office: Hokkaido; President: Motoki Susa) serving as the distributor.
LNPs have been used in mRNA vaccines for COVID-19 and are expected to find broader applications in vaccines against various infectious diseases and cancer in the future.
In recent years, LNP production methods using microfluidic devices have attracted attention both in Japan and internationally. LNPs are created by rapidly mixing lipid and nucleic acid precursor solutions. Using a microfluidic device in the process enables more precise control of the LNP particle size than conventional manufacturing methods. However, there was a productivity issue with LNP production methods, as they could only produce small amounts of particles at a time.
By combining Hokkaido University's proprietary iLiNP® microfluidic device with Shin-Etsu Chemical's materials (primarily synthetic quartz) and processing technology, a microfluidic device has been developed that is suitable for use in mass production. Additionally, leveraging the system design expertise of our subsidiary Shin-Etsu Engineering, we have developed an LNP production system that mounts this microfluidic device and that complies with the Good Manufacturing Practice (GMP) requirements for pharmaceutical manufacturing.
The complete press release can be downloaded as a PDF.
