BI-PurEX™ is a modern downstream development strategy designed to increase flexibility in order to adapt efficiently to all costumer requests. The open and modular design is highly optimized for fast, efficient and target-oriented development of purification processes of therapeutic proteins.
Within BI-PurEx™, each purification step is defined and evaluated for its development potential. Modern and extremely efficient high-throughput screening methods (RAPPTor™) that are optimized for minimal material demands are applied early in development. The implementation of statistical modeling (DoE) and an integrated decision tree improve the efficiency of development and result in an intelligent, lean, cost-effective development process. A decision tree is integrated with an analytical toolbox to improve understanding and accelerate the elimination of problematic events observed during development.
The combination of these methods into a technology platform generates critical know-how for each target protein and results in a significant competitive advantage compared with a typical platform process, without disregarding the need for a very tight development timeline. The innovative and integrated approaches to the BI-PurEX™ strategy guarantee that even complex challenges lead rapidly and economically to an efficient and robust purification process. The approach offers flexibility, speed, and cost efficiency as well as high yield and the highest possible product quality.