Adimmune Corporation (TWSE: 4142) has been adopting Quality by Design (QbD) practices to align with international standards, enhance its capabilities in process and product development, support international CDMO (contract development and manufacturing organization) projects, and drive new business and technology expansion. By applying QbD across stage from process design to clinical and post-market product development, the company has significantly strengthened its overall development capacity.   

Vivian Wang, Vice President of Adimmune, explained that QbD is a global regulatory initiative in the biopharmaceutical sector, and a foundational concept endorsed by the U.S. FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The goal is to proactively design and control the end-to-end manufacturing process to consistently deliver high-quality products, ensuring the safety and efficacy of each batch. She emphasized that the complex nature of biologics means that every step of the manufacturing process can impact product quality and biological activity. Building on its existing foundation in process development and product management, Adimmune has established solid systems for quality and production control.   

Adimmune recently announced that Wang will now concurrently serve as Head of Product Development, in addition to her current role as Vice President of New Technology and Process Development. She will oversee both divisions in line with the company’s ongoing internationalization strategy.   

Wang brings over 30 years of experience in the biopharmaceutical industry. After earning a degree in Plant Pathology from National Taiwan University, she obtained a master’s degree in tissue culture from the University of California. She spent 23 years in the San Francisco Bay Area working in process design and manufacturing development, holding positions at Bayer and Genentech. She has extensive experience in process development from early-stage to commercial-scale production. During her tenure at WuXi Biologics in China, she led multiple international CDMO projects from regulatory filing to successful market launch.