Mycenax Biotech Inc. (TWO:4726) is a contract development and manufacturing organization (CDMO) specializing in biologics and biosimilars, providing end-to-end biopharmaceutical services from cell line development and process development to PIC/S GMP-compliant manufacturing of drug substances and drug products. Founded in 2001 and headquartered in Zhubei, Taiwan, the company operates two GMP facilities approved by regulators including the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Korea's Ministry of Food and Drug Safety (MFDS), and Health Canada; it serves clients in Taiwan, Japan, Korea, Singapore, other Asia-Pacific regions, Europe, and the United States. Core offerings encompass mammalian manufacturing of monoclonal antibodies, bispecific/multispecific antibodies, and recombinant proteins; microbial manufacturing of plasmid DNA, recombinant proteins, and enzymes; antibody-drug conjugates including conjugation technology and linkers; cell and gene therapy modalities such as stem cell therapy, immune cell therapy, CAR genetic engineering, and exosomes; plus analytics services like analytical method development/validation and testing.
Mycenax supports developability assessment, program evaluation, drug characterization, and tech transfer, leveraging integrated platforms for efficient, cost-effective solutions in traditional and emerging therapies. The company develops and manufactures products including fc-fusion proteins, peptides, protein conjugates, antibody-cell conjugates, antigen-binding fragments (Fab), single-chain variable fragments (ScFv), and DNA vaccines from mammalian and microbial cell lines.