This webcast features: Van Leang, Senior Director of Global CMC Operations, HJB Bio
Vendors supporting biologics manufacturing are developing equipment to enable continuous process in downstream operations. Using continuous downstream operations reduces operational time and raw material costs. HJB has developed a downstream hybrid process that uses an automated batch approach to achieve a continuous downstream capture process. This allows the use of the current monoclonal antibody (MAb) capture platform but reduces cost overall by adopting the benefits of continuous chromatography without the huge regulatory burden.
The HJB downstream capture process columns are cycled rapidly (8-10 cycles) throughout the whole day in order to use less resin than a typical phase 1 process. These cycles are programmed automatically without operator intervention, which allows for faster cycle operations. Over several campaigns, the Protein A capture step has already achieved productivity up to 20 g/L/hr without need for multiple columns while also reducing the capture resin costs for phase 1 by 50% over a typical batch process that utilizes the Protein A column for 4 cycles a batch.
The audience will learn how to
- choose the residence time for a mAb capture step to include total operational time
- increase productivity by using smaller columns with more cycles
- implement automation into batch processes.
Watch the recorded webcast now.