Figure 1: () Antibody fragments (e.g., Fab, scFv, DAb, etc.) are set to become the next important class of protein-based biotherapeutics after monoclonal antibodies (MAbs). One of the advantages is that due to their structure and smaller size, antibody fragments possess unique properties (e.g., easier tissue penetration) that suit a range of diagnostic and therapeutic applications. The industry standard for purifying MAbs is a platform approach using affinity chromatography with protein A as the capture step. The…
Author Archives: Gustav Rodrigo
Optimization, Robustness, and Scale-Up of MAb Purification
The biopharmaceutical industry needs faster and more efficient development of new drugs and their market introduction as well as shorter process development times for both upstream and downstream operations. It has become more commonplace to use high-throughput development techniques to save time (1). Development is also sped up by applying platform technologies based on the unsurpassed selectivity of protein A resins (2,3,4,5,6), which is the foundation for downstream processing of monoclonal antibodies (MAbs). This is the second of two articles…
Rapid and Scalable Microplate Development of a Two-Step Purification Process
High-throughput screening and process development methods are becoming more widely used in the biopharmaceutical industry. Recent development of high-expression (high–target-titer) recombinant culture methods has enhanced the need to also develop more effective separation products, methods, and processes (1). Part of the solution would be chromatographic resins offering higher capacities and flow rates. However, developing an optimized purification process that involves several chromatographic steps can consume significant time and samples. In addition, a purification process developed…