Scalable Method for Packing Chromatography Columns

Currently the bio-pharmaceutical industry is heading towards cost cutting, time saving and single use manufacturing approach. This has opened up a whole new market for disposable technologies. Pre-packed disposable chromatography columns are a best fit for preclinical and clinical stage Monoclonal Antibody (mAb) production and vaccine manufacturing processes which require quick turnaround times and aggressive validation respectively. This work describes development of pre-packed and ready to use chromatography columns to meet this need in the industry. A robust packing method was developed to pack two different types of resins of different particle sizes, one with a polyacrylate base matrix and the other with a polyvinyl ether base matrix. The column performances were evaluated by measuring height equivalent theoretical plates (HETP), asymmetry, pressure-flow characteristics and protein retention. The results showed that the method is reproducible and scalable over a column volume range of 1.6 to 16.1 lit. Further, the columns retained their performance characteristics even after severe vibration and drop tests. This suggests that the method developed and the column designs are desirable for a pre-packed and disposable chromatography format.