Author Archives: Brian Kluck

Evaluation of a Next-Generation Protein A Chromatography Resin for the Purification of Monoclonal Antibodies

Next-generation, high-capacity, alkali-stable protein A resins have recently become available in anticipation of increased production and throughput demand for protein therapeutic processes. Efficient caustic cleaning and bioburden control regimens have allowed agarose-based, alkali-stable protein A chromatography resins to become the backbone of many commercial purification processes for over a decade and have served as the primary capture step for monoclonal antibody (MAb) purification processes. However, the relatively high raw material costs, along with limitations to binding capacity and aggressive resin…

Streamlining Downstream Process Development

Normal-flow filtration is used throughout downstream processes for biologics including depth, sterile, and viral filtration applications. Because of its ubiquity in large-scale biomanufacturing, using the most efficient normal-flow filter media area and type can lead to significant cost savings. To determine the most effective media type and area, developers use a scaled-down process model is used in bioprocess laboratories to minimize material requirements. Constant–flow-rate filter evaluations involve direct scale-down parameters that match manufacturing-scale process conditions. This type of evaluation can…