As clinical applications of monoclonal antibodies continue to engage the healthcare community, biopharmaceutical manufacturers are striving to make products available as quickly and efficiently as possible. Improved methods of process development and ready-to-use purification solutions are already minimizing the impact of many laborious tasks in MAb manufacturing.
Eliminating tasks such as column packing and testing, membrane wetting and rinsing, and system cleaning and validation paves the way for major cuts in downstream processing time. Combining such savings with rapid screening and optimization means further gains at the start of purification development. Add highly robust scale-up and the stage is set for shortening the time-to-clinic journey for MAbs
High-throughput screening and optimization of a Protein A capture step in a monoclonal antibody purification process
One study describes an optimized capture step for the purification of a monoclonal antibody (MAb) on MabSelect SuRe, which is a Protein A-based affinity chromatography medium. The use of PreDictor prefilled 96-well filter plates allowed us to investigate a large experimental space in order to find the best conditions for the capture step. Once these conditions were identified, fine-tuning and verifications were carried out with HiScreen prepacked columns on an ÄKTA™ design system. Finally, a scale-up protocol was developed and tested under robust production conditions. The procedure described in this application note represents an efficient and robust solution for high-throughput process development. See the full text of the application note: High-throughput screening and optimization of a Protein A capture step in a monoclonal antibody purification process
High-throughput screening and optimization of a multimodal polishing step in a monoclonal antibody purification process
Another study used Capto adhere and MabSelect SuRe chromatography media to significantly reduce the level of IgG antibody aggregates in a sample using an efficient two-step method that resulted in high yields and purity. In addition, we have developed a screening format employing the exceptional capabilities of PreDictor 96-well filter plates, HiScreen™ prepacked columns, and a Design of Experiments (DoE) approach for effective and rapid screening for optimal experimental conditions. Application of the optimized protocol led to a reduction in aggregate levels from 12.6% to < 0.5% in a single step with a monomer yield of 87%. Host cell protein (HCP) and ligand leakage were reduced to negligible amounts. In total, 192 conditions (flowthrough and selective elution experiments) were screened in approximately 4 h and analyzed in 48 h. The use of a high-throughput method in the process described here led to a speedy identification and subsequent optimization of the initial conditions. See the full text of the application note: High-throughput screening and optimization of a multimodal polishing step in a monoclonal antibody purification process