Karen Wen, PhD

● Over 30 years of R&D experience in drug and biologics development, PIC/S GMP and GDP, IVD development, ISO system, monoclonal antibody development and business development; a product development expert
● Over 25 years experience in corporate governance, business development, R&D, manufacturing, and GMP/GDP quality systems
● Co-Founder and former President, Mycenax Biotech Inc., 2011-2018
● Former Vice President and Manager, Department of Quality Assurance of Mycenax Biotech Inc., 2001-2011
● Former Research Fellow, Development Center for Biotechnology, Taiwan; Former Head of Research and Development for ISO plant for IVD, 1993-200
● PhD, Department of Biomedicine, Old Dominion University and Eastern Virginia Medical School, USA

Dr. Karen Wen is a pioneer in the field of process development and PIC/S GMP production of biological products, including peptides, proteins, monoclonal antibodies, DNA vaccines, and antibody-cell conjugate products. As the co-founder and former CEO of Mycenax Biotech Inc. (the first CDMO in Taiwan), she has profound experience in CMC: chemistry, manufacturing, and control. During her tenure at Mycenax, she completed one product launch, one biosimilar in a global trial of bioequivalence in pharmacokinetics, and initiated and made major strides in several pipelines at the pre-IND stage. Beyond pipeline development, Karen had set up the GMP system at the Mycenax facility and led this facility to become the first to adopt single-use technology in Asia and the first 2000L—the largest, disposable bioreactor in the world. She had also led Mycenax to collaborate with Biosana to pursue the development of full-line continuous manufacturing, and was first to reach the clinical phase.

Karen received her PhD in Biomedical Science at Old Dominion Univ./Eastern Virginia Medical School in the US and her B.S. in Chemistry at National Taiwan University. She served as the principal investigator and researcher in the Division of Immunology and IVD Product Development at Development Center of Biotechnology. During her tenure, she successfully developed and commercialized the ELISA kits for drug residue determination (sulfa drugs, chloramphenicol, beta-agonist)  in veterinary and dairy products, and ELISA and rapid tests for abused drug residue determination (methamphetamine, morphine, cocaine, marijuana, FM2).

Karen specializes in product development, GMP system set-up, CMC, product strategy, business development and company strategy.