MabPlex International

MabPlex International operates as a Contract Development and Manufacturing Organization (CDMO), providing integrated services for the global biopharmaceutical sector. Founded in 2013, the company has established itself as an end-to-end service provider, managing all critical steps from DNA sequencing to the final drug product in-house. Its headquarters are in Yantai, China, with additional R&D and manufacturing sites in Shanghai and San Diego, California. This global footprint allows MabPlex to serve clients in Asia, Europe, and the United States.

The company's business model is centered on providing comprehensive, contract-based solutions that cover the entire lifecycle of biopharmaceutical development and manufacturing. This includes cell line development, process characterization, regulatory filing support, and cGMP (Current Good Manufacturing Practice) production for clinical trials and commercial supply. MabPlex serves biopharmaceutical and biotechnology companies by manufacturing complex biologics, including monoclonal antibodies (mAbs), recombinant proteins, bispecifics, and antibody-drug conjugates (ADCs). A key specialization is the large-scale production of ADCs, a targeted cancer therapy, positioning it as one of the few global providers with this capability. The company also has an affiliated brand, CelluPro, that develops and manufactures high-quality, serum-free media for mammalian cell culture.

MabPlex's service offerings are structured to guide clients from pre-clinical studies through to commercialization. The firm provides expertise in navigating complex regulatory processes for agencies like the US FDA, European EMA, and Chinese NMPA. Its manufacturing capabilities are substantial, featuring multiple production lines with single-use bioreactors up to 2,000L and ADC conjugation scales up to 150L. This infrastructure supports the production of both liquid and lyophilized (freeze-dried) drug products. The company has a demonstrated history of milestones, including securing significant Series A and B financing rounds, and receiving multiple industry awards such as the Frost & Sullivan Global Growth Excellence Leadership Award for its ADC manufacturing services.

Keywords: Contract Development and Manufacturing Organization, CDMO, biopharmaceutical manufacturing, antibody-drug conjugates, ADC production, monoclonal antibodies, biologics development, cGMP manufacturing, cell line development, recombinant proteins, bioprocess development, pharmaceutical services, preclinical studies, commercial production, CMC services, aseptic filling, lyophilization, Yantai, San Diego, global CDMO, biologics manufacturing solutions, biopharmaceutical outsourcing