THE 30STARTUPS OF KANSAI

Solallis Bio Inc. is a Kyoto-based startup that develops and manufactures GMP-compatible biomaterials — cell culture media and cryopreservation solutions — which are animal origin-free and chemically defined, supporting the industrialization of regenerative medicine and cell therapy. Our products include StemDesign, a medium that expands mesenchymal stromal cells (MSCs) while keeping them from senescing; ELSSA OSFree, the world’s first cryopreservation solution for cells and exosomes that uses no organic solvent; and media for exosome production. Patents are pending in the United States, China, Germany and the United Kingdom, and our development is supported by the Kyoto and Osaka prefectural governments.

Cell therapies work, yet they struggle to reach the patients who need them. Raw materials are expensive and vary from lot to lot, so manufacturing costs stay high; and DMSO — or its substitutes — in conventional cryopreservation solutions is known to cause side effects on administration and to degrade cell quality. Our media and cryopreservation solutions enhance the therapeutic function of cells, enable large-scale culture at consistent quality, and connect freezing, shipping and administration entirely DMSO-free. We serve cell therapy developers and CDMOs, the clinicians who deliver treatment, and above all the patients waiting for it.

Our distinctiveness lies in formulation design that delivers both safety and regulatory compliance. Our media are animal origin-free and chemically defined, with every ingredient specified, minimizing lot-to-lot variation and simplifying regulatory explanation. ELSSA OSFree is the world’s first cryopreservation solution that uses no organic solvent at all — including cytotoxic DMSO — sustaining high viability and cell function while lowering the risk of side effects on administration. Everything is manufactured under GMP-compliant systems and designed to meet the strict quality and safety regulations of Japan, the US, Europe and Asia, and the same formulation carries from research through to commercial manufacturing.

Beyond our MSC products, we will extend the portfolio to xeno-free GMP media for iPS cells, T cells and NK cells, aiming to become the raw-material platform that supports every modality in regenerative medicine. In Japan we are working to have our products adopted in clinical development programs, while planning expansion into China, South Korea, Taiwan and Southeast Asia as well as Europe and the United States. Our goal is to make high-quality Japanese biomaterials a global standard, and to help make cell therapy safer and available to far more people.