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HARK CHEN
Executive Director, Manufacturing & Technical Operation
Executive Director, Manufacturing & Technical Operation
HARK CHEN
Hark Chen, Executive Director is responsible in Manufacturing Technology Operation Division. Hark was the co-founder of Mycenax Biotech Inc. in 2001. During her days in Mycenax from 2001 to June, 2019, she took the responsibility in establishing two mammalian, one microbial and one fill-finish production lines, served as the director of GMP facility and deputy general manager of the process development department. She has accumulated 20 years of professional experience in the field of GMP factory management and production process development in the biopharmaceutical industry and participated in the development of several biological products from bionovels, biosimilars, glycan-protein conjugate, monoclonal antibody, and immune cell conjugate. She led her team to accomplish lots pioneer tasks including 1) perfusion operation in mammalian cell production in 200L single-use wave bioreactor process in 2004, 2) a new biological product for rheumatoid arthritis from cell line development to commercialization from 2004 to 2018, 3) the first monoclonal antibody produced in 2000L single-use stirred mammalian cell bioreactor in Asia in 2014, 4) a full-line continuous process development applied in a biosimilar product for phase I use, and 5) a monoclonal antibody conjugated with immune cells in a 200 L production scale. Hark Chen got her master degree in chemical engineering in National Taiwan University of Science and Technology Institute.