Boosting the Efficiency of mAb Purification using CaptureSMB
Application Notes
Integration of CaptureSMB and membrane flow-through processes into a 3-step monoclonal antibody purification platform process provides a 3-fold improvement in productivity and large operational cost savings compared to a standard batch platform process.
mAb capture process
CaptureSMB is an optimized twin column periodic countercurrent process (PCC) with the least complex hardware configuration - yet being superior in performance compared to batch processes and other multi-column PCC processes. The mAb capture process with CaptureSMB allows
- fast processing of large feed volumes in a short time preserving product integrity
- up to three-fold higher productivity reducing protein A column sizes
- increasing utilization of expensive Protein A resins/membranes with up to 60% protein A resin savings
- 50% lower buffer consumption compared to a batch process
CaptureSMB can be easily implemented starting from normal breakthrough curve data using a software conversion tool within the operating software.
CaptureSMB has been scaled to pilot and production scale runs on a GMP Contichrom TWIN system (YMC) by Bristol Myers Squibb (Bioprocess International, April 2018 Scale-Up of Twin-Column Periodic Countercurrent Chromatography for MAb Purification). The study shows:
- Excellent scalability of established ChromaCon CaptureSMB processes from lab scale (Contichrom CUBE) to GMP pilot and production scale (Contichrom TWIN)
- Significant reduction of operating time and costs in clinical trial manufacturing and commercial production
The Contichrom TWIN is designed for single-use operation with sterile connectors upstream and downstream to the system.
mAb polishing processes
The polishing processes are intended to remove residual impurities and potential virus contaminants. They can be designed as bind-elute or flow-through processes. We propose a robust two-step membrane polishing process combining a cation exchange flow-through process step for removal of aggregates and a single-membrane anion exchange flow-through step with an in-line dilution for pH/conductivity adjustment.
- Maximum process performance in mAb polishing, using highly productive and robust flow through processes
- Shorter processing times and a 3-fold higher productivity step in the cation exchange step, due to faster flow rates by using membranes with a flow-through process
- Same multi-process GMP Contichrom TWIN system (YMC) can be used for combining both polishing steps using one equipment
- Adds flexibility in manufacturing by allowing to produce pilot-scale and commercial-scale API quantities with the same equipment and infrastructure
