The co-founder and president of Mycenax Biotech, Dr. Karen Wen details the key lessons learned from the development of their first in-house product TuNEX® and how they have been applied to their second flagship product LusiNEX (tocilizumab). She also details the company’s transition from a platform-driven service provider to a product-driven player, underscoring the significance of their traditional capabilities in chemical, manufacturing, and control (CMC) as a value-added asset and key differentiating factor for their partners in the biologics space. In June 2016, the results of two phase III trials provide clear evidence of TuNEX®’s efficacy and a few months later, at the end of December 2016, you signed a ten-year, drug authorization distribution contract with Orient EuroPharma, spanning nine countries in Southeast Asia. Congratulations! Beside the economic impact for the company, why are you particularly proud of these two achievements?
"It is worth touching upon the sheer level of complexity and sensitivity involved in biologics manufacturing, especially when compared to small molecules. Any divergence in the manufacturing process, however miniscule, can result in a completely different end product."