Kudo Biotechnology

Kudo Bio has a state-of-the-art clinical GMP manufacturing facility and MSAT laboratories in Shanghai, with additional presence in Boston and Singapore. Its GMP manufacturing facility spans more than 57,000 sqf and is designed in accordance with cGMP and global regulatory guidelines, featuring two plasmid lines, three mRNA lines, two LNP bulk lines, and one drug product fill & finish line.

The company's production lines cater to manufacturing needs for preclinical through Phase II clinical trials, with the capacity to manufacture up to 40 million vials/year for Phase III and commercial manufacturing. Its equipment is customized for mRNA and LNP drug development, and offers a range of additional services, including: process and analytical development, technology transfer, fill & finish, testing & release, and supply chain management.

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