Author Archives: Jie Chen

Ask the Expert: Evaluation of the “Scale-Out” Biomanufacturing Strategy — from Early Clinical Stage to Commercialization

In a BPI Ask the Expert webinar on 2 November 2017, Jie Chen (vice president of CMC management at WuXi Biologics) spoke about scale-out biomanufacturing strategies. Chen’s Presentation Scale-out strategies allow for the use of disposable bioreactors in commercial manufacturing. A scale-out strategy offers unique advantages over traditional scale-up manufacturing: Reduces risks to product quality and process performance as manufacturing scale increases Allows for flexible process design and validation strategies Accommodates a wide range of productivity levels and market demands…