Shawn Wang
Director, Head of Material Development Kite Pharma Inc
Shawn (Xueyuan) Wang is a Director in Kite Pharma Process Development. He leads the raw material group in Kite focusing on new material (single use and chemicals/reagents) development and implementation, commercial readiness and lifecycle management for Kite clinical and commercial programs.
He has a B.S. in Biology from University of Science and Technology of China and a Ph.D. in Polymer Engineering from the University of Akron. He started his career in a polymer film R&D company, then moved to the pharmaceutical industry to work as material SME. He has over 14 years’ experience working in raw materials application in biopharmaceutical industry in Genentech and Bayer. He supported the single use facility build up in both Genentech and Bayer before moving to Kite to focus on cell therapy applications. More recently, his focus is to ensure raw material selection for Kite T-cell and viral vector manufacturing process, build robust supply chain and evaluate new material to support Kite world-leading cell therapy manufacturing process.
Seminars
Moving from research to GMP and then to commercial materials is a common source of delay and regulatory risk when this strategy is not planned early. Many teams discover too late that materials used in early development cannot scale, or that supplier controls are not aligned with late-stage expectations. This workshop focuses on how to plan material grade transitions proactively so your scale up journey can progress without disruptive requalification or friction in your process changes.
This workshop will discuss:
- Identifying materials that will not scale beyond research or early GMP use
- Assessing supplier readiness and grade roadmaps before phase three
- Aligning material grade strategy with development phase to reduce requalification work
- Discussing the transition from late-stage to commercial and long-term life-cycle monitoring via the CPV process and improvements to raw materials
- Addressing challenges in qualifying secondary suppliers for critical materials
- Understanding comparability and change control requirements when switching vendors
- Balancing supply chain flexibility with IP constraints
