Mycenax is a fully dedicated CDMO specializing in process development and cGMP manufacturing for innovative biologics and biosimilar products. Leveraging extensive scientific and technical expertise in enabling pharmaceutical and biotech partners to optimize product development and bring their treatment to market, we provide a comprehensive range of solutions, including monoclonal antibodies (mAb), bi/multi-specific antibodies (BsAb/MsAb), antibody drug conjugates (ADCs/PDCs), plasmid DNA, cell therapy products, vaccines, small peptides, and fusion proteins. Using advanced platforms and PIC/S GMP-compliant manufacturing facilities, we offer quality and efficient one-stop integrated services from DNA to Drug Product to our clients globally.

Our expertise covers cell line development (CHO, Sp2/0, E. coli), process development, formulation, analytical method development, GMP manufacturing, and aseptic fill-finish. Mycenax excels in managing projects from cell line development to GMP production and demonstrates a proven track record in technology transfer for site-change manufacturing and Process Characterization and Validation (PC/PV). This includes successfully scaling up operations for projects ranging from pre-clinical to commercial production. Our formulation team has successfully worked on novel biologic products and biosimilars in various dosage forms, complemented by analytical capabilities for comprehensive testing of diverse biological products.

Operating in compliance with cGMP regulations, our two GMP plants handle projects from pre-clinical to commercial production. GMP Plant 1, established in 2005 with expansions, features three production lines, including a mammalian production line, a microbial line, and a fill-finish line for liquid and lyophilized forms. GMP Plant 2, completed in 2022, features two drug substance (DS) production lines, each with up to three 2,000L bioreactors, and one fill-finish line for both liquid and lyophilized forms with increased batch capacities, facilitating flexible production to meet the varying drug product quantities required for clinical trials and commercial supply across different biologic modalities.

Our GMP facility has undergone 70+ audits by EU QPs (Qualified Persons), Taiwan FDA, and global clients. In 2018, we achieved the milestone of becoming the first local company to obtain Taiwan FDA’s granted license approval for a biological product. Currently, we have integrated modern digital systems, eQMS and LIMS, for effective quality system management. This ensures our ability to consistently uphold satisfactory GMP standards, in compliance with regulations from EU, Japan, US, and PIC/S, for our global clients.

As your Best Partner, Mycenax provides quality and time-effective integrated biologics development and manufacturing services to our clients worldwide.