NGK Starts Development for World's First scalable Ceramic Membrane-Based　Device for LNP Manufacturing*

NAGOYA, Japan, September 16, 2026 –NGK Corporation today announced the start of development for the world's first scalable ceramic membrane-based lipid nanoparticle (LNP) manufacturing device. The technology is designed to address one of the key challenges in LNP manufacturing: maintaining product quality while moving from laboratory development to commercial-scale production.

LNPs are nanoscale lipid capsules used as drug delivery systems for mRNA vaccines and other nucleic acid therapeutics. LNPs are formulated by the mixing of a lipid solution and an API solution. However, manufacturers typically rely on various mixing mechanisms at different stages of development. Microfluidic systems are commonly used during research and development, while membrane-based or other approaches are often required for larger-scale production. However, switching between mixing technologies can change LNP properties, introducing additional process development challenges and potentially affect product characteristics.

NGK's ceramic membrane device was developed with the intent to enable LNP formation using the same mixing principle across multiple production scales. By adjusting membrane area and porosity according to throughput requirements, the device aims to support laboratory-scale, pilot-scale, and future commercial-scale manufacturing while maintaining a common process concept.

Evaluation studies demonstrated that LNPs produced using NGK's ceramic membrane technology　maintained particle characteristics across a broad operating flow-rate range and showed physicochemical properties, biological performance, and structural characteristics comparable to those produced using conventional microfluidic manufacturing methods.

• Key Advantages

Broad Scalability

NGK's LNP production system is designed to use the same mixing principle across production scales ranging from research and development to commercial manufacturing. This is achieved by adjusting the effective membrane area and porosity according to the processing volume. As a result, the system aims to facilitate a smooth transition from development to production.

In a joint evaluation conducted with TAIYO HOLDINGS CO., LTD. (Toshima, Tokyo, Japan), a company engaged in pharmaceutical contract manufacturing and sales, the system demonstrated superior LNP formation performance at medium production scales compared with conventional metal membrane emulsification technology.

Consistent LNP Quality

The in vivo behavior of LNPs varies depending on their particle size, which in turn affects their pharmaceutical performance. NGK's technology utilizes a ceramic membrane with highly uniform pore sizes, enabling the production of high-quality LNPs with a narrow particle size distribution.

In joint evaluations conducted with TAIYO HOLDINGS CO., LTD. and DDS Strategy Firm LLC (Koto City, Tokyo, Japan), it was confirmed that LNPs produced using NGK's technology exhibited particle characteristics and biological functionality comparable to those produced using conventional technologies across a wide range of manufacturing conditions.

Single-Use and Flexible Manufacturing

The replaceable membrane design supports single-use operation, which eliminates the need for CIP/SIP procedures. This helps streamline manufacturing processes and minimize the risk of cross-contamination, providing a flexible approach to multiproduct manufacturing.

High Chemical Compatibility

As the device utilizes ceramic materials, it offers excellent chemical stability and compatibility with a wide range of solvents and formulation conditions, supporting next-generation pharmaceutical process development.

• Background

Under its “New Value 1000” initiative, NGK is expanding the application of its core ceramic technologies into new growth areas. Building on decades of expertise in ceramic membrane technologies, the company launched full-scale development of ceramic membrane-based LNP manufacturing technology in FY2025.

The global market for LNP-enabled medicines is expected to continue expanding beyond COVID-19 vaccines into applications including gene therapy, oncology, and other nucleic acid therapeutics, driving demand for scalable and reproducible manufacturing solutions.

• Outlook

NGK views the technology as a foundational manufacturing device for next-generation mRNA and nucleic acid medicines. The company will continue collaborative evaluations with pharmaceutical companies, CDMOs, and research institutions while advancing development toward larger-scale manufacturing applications.

By helping connect process development and manufacturing through a common device, NGK aims to contribute to the efficient development and commercialization of next-generation medicines.

Schematic Illustration of NGK's Ceramic Membrane-Based LNP Manufacturing device

About NGK Corporation

Founded in 1919, NGK is a ceramics manufacturer active across a wide range of fields, including mobility, energy, IoT, and industrial applications. Its principal products include ceramics for semiconductor manufacturing equipment and automotive components, and the company continues to strengthen its presence as a global business, with overseas sales accounting for roughly 80% of revenue and overseas employees for roughly 60% of its workforce. Since setting out its vision in 2021 to contribute to a carbon-neutral, digital society through its ceramic technology, NGK has accelerated the transformation of its business portfolio, and in April 2026 changed its corporate name from NGK Insulators, Ltd. to NGK Corporation. Guided by the NGK Group mission — “New Value for a Better Future” — the company continues to pursue a more comfortable and sustainable society through the delivery of new products and services. https://www.ngk-global.com/