STC Biologics, Inc. is a boutique turn-key biologics CDMO located in Newton, Massachusetts, USA, founded in 2009. The company provides full CMC services and consulting to enable partners to advance biologic products from discovery to commercialization. Their team brings expertise from Genentech, Novartis, Shire, EMD Serono, Lonza, Alexion, and Merrimack. STC offers a Speed-To-Clinic Platform for monoclonal antibodies that can go from royalty-free cell line development directly to cGMP manufacturing and released drug substance within 12 months. They opened a single-use mammalian GMP facility in 2019 and have filed 8+ BLAs, dozens of INDs, and 20+ comparability protocols. They also developed their own biosimilar product, STC101.
biologics CMC development, monoclonal antibody development, cell line development, Speed-To-Clinic platform, biosimilar development, BLA and IND filing, GMP biologics manufacturing
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