Stephen Lew

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of living drugs. The company enables drug sponsors to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand. Cellares' fully automated platforms, Cell Shuttle for end-to-end manufacturing and Cell Q for automated quality control, are deployed across its global network of IDMO Smart Factories. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10x more batches than conventional CDMOs with comparable footprint and headcount. The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA's Advanced Manufacturing Technology (AMT) designation, with a 100% automation success rate across more than a dozen automated processes. Cellares has achieved key clinical validation milestones, including FDA clearance of IND Amendments enabling active clinical manufacturing on the Cell Shuttle and the successful dosing of first patients in partner clinical trials across multiple therapeutic areas, including oncology and autoimmune indications. Headquartered in South San Francisco, California, Cellares operates Smart Factories in Bridgewater, New Jersey, Leiden, the Netherlands, and Kashiwa City, Japan, purpose-built to support clinical and commercial programs and expand access to life-saving cell therapies worldwide.