Commercialization Roadmap
NSiS is pursuing a phased commercialization strategy, expanding from research-use proteins (RUO) to GMP-grade raw materials that meet the quality and manufacturing standards required for pharmaceutical production. With RUO products now available, NSiS will advance process scale-up and validation, establish GMP manufacturing and quality systems, and target the launch of GMP-grade raw materials for clinical and commercial use in 2029.
Ready for RUO
Fully human proteins available asresearch-use reagents, with a pipeline spanning five product classes.
Scale-up &
validation
Process scale-up, analytical and comparability studies, and pilot production lots.
GMP Readiness
GMP manufacturing and quality systems; regulatory groundwork, including DMF and CoA.
GMP-Grade products
Targeted launch of GMP-grade raw materials for clinical and commercial applications.
Multiple Revenue Models Built on the Platform
Building on the Fully Human Protein Platform, NSiS is developing multiple revenue models aligned with each stage of business growth. Starting with the sale of research-use proteins (RUO), NSiS plans to expand into contract protein development and manufacturing and the supply of GMP-grade raw materials, followed by co-development and licensing with pharmaceutical and biotechnology companies, and ultimately, the development of its own therapeutic assets.
Customer & Partner Engagement
The NSiS platform has attracted interest from pharmaceutical and biotechnology companies, CDMOs, universities, and research institutions in Japan and internationally across a broad range of protein manufacturing needs. NSiS is currently focused on contract synthesis of RUO-grade proteins and contract PoC projects, with the goal of progressively expanding into co-development and licensing, followed by future GMP technology transfer and commercial supply.
Making Fully Human Proteins Possible — Together
Talk to NSiS about hard-to-produce proteins, next-generation therapeutic modalities, and co-development opportunities.