Who We Are

NorCal GMP is a contract development and manufacturing organization (CDMO) providing services for emerging and established biopharmaceutical companies eager to bring their innovative molecules to market. Our vision is to be a prominent and reputable member of the CDMO industry that biopharmaceutical companies return to for our reliability and consistency. We are committed to help biopharmaceutical companies bring their therapies to reality and transform their patients’ lives.

Constructed in 2021 and located in Hayward, California, our cutting-edge cGMP facility specializes in the manufacture of high-quality mammalian-derived monoclonal antibodies and protein biologics from clinical to commercial scale production. Our cleanroom is equipped with dedicated suites for upstream and downstream processing and media and buffer production, so that all aspects of production are controlled in-house to efficiently deliver a consistent product. In addition to our manufacturing capabilities, our site offers a multitude of services including analytical quality testing, cell banking, media and buffer production, drug product depot and distribution, as well as personnel training for compliance with current good manufacturing, laboratory, and documentation practices.

Our robust quality systems ensure the safety, efficacy, and consistency of every biopharmaceutical product we manufacture. Equipped with state-of-the-art analytical technologies operated by skilled personnel, our laboratories rigorously monitor every stage of production by testing raw materials, in-process samples, and formulated drug product. We maintain a strict adherence to the highest regulatory and industry requirements with a strong emphasis on documentation compliance, product integrity, and operational excellence. Our commitment to quality is embedded in everything we do, striving to not only satisfy but exceed regulatory requirements.   

Our manufacturing and quality services are supported by facility infrastructure that ensures operations run without interruption. This includes well-maintained utilities, meticulous monitoring systems, and consistent cold storage solutions. These combine to create a well-maintained environment that optimizes workflow efficiency and enhances operational output. Our facility’s infrastructure is flexible allowing us to adapt to evolving production demands and technological advancements. We recognize that such infrastructure is vital to upholding product integrity and reinforces our commitment to excellence and client satisfaction.

Currently, our company has successfully completed 13 production lots of drug substance of TrueBinding’s TB006. Drug product from these lots is distributed from our facility, supporting three clinical trials and supplying 20 clinical sites across the United States.