Continuous Capture At GMP Scale
A significant milestone has been achieved in scaling up the CaptureSMB process, an optimized two-column periodic countercurrent capture process for the purification of monoclonal antibodies from laboratory scale to industrial pilot and production scale. A team from Bristol-Myers Squibb (Devens, MA), ChromaCon (Zurich, Switzerland) and LEWA (Devens, MA; now YMC) reports in an article in BioProcess International (online February 2018, print April 2018) about the Scale-Up of Twin-Column Periodic Counter-Current Chromatography . The article shows the seamless transfer of a laboratory-scale CaptureSMB process to pilot/process scale, achieving excellent results.
The lab-scale experiments were run on a Contichrom CUBE (ChromaCon). The results from these experiments were excellent predictors of the performance on the 100x greater pilot and production scale runs on a Contichrom TWIN system (YMC). Compared to batch capture processes, a 2.5-fold higher productivity, an increase in resin utilization from 67% to 92%, and a 50% reduction in buffer consumption could be realized.
The Contichrom TWIN system has been further scaled up to production scale. The picture depicts a customized Contichrom TWIN system 300 with 20L/min.