Advancing next gen biologic manufacturing by implementing continuous downstream processing platform
An integrated downstream process is needed to efficiently support ever increasing pipeline and demand of mAbs in clinical development. In spite of several technological advancements, downstream is still a major bottleneck.
An average biologic manufacturing process consumes hundreds of raw materials/consumables. Herein, we will present an integrated continuous downstream purification process that utilizes a novel approach to connect several chromatography steps along with use of single-use powder dispensing and hydrated buffers to improve flexibility, throughout and cost of goods. Additionally, we demonstrated the use of novel additives and resins to increase impurity clearance to meet quality while reducing process time.
This presentation was given during BPI Europe, May 10, 2023.
Dr. Nandu Deorkar