mAb Downstream Processing

Choosing resin and buffer conditions means matching resin chemistry with shifting load and impurity profiles. Using 96-well screening plates, POROS resins, and buffer libraries, teams can rapidly identify optimal combinations for recovery and purity across capture and polish steps. FAS support can help guide the interpretation of screening data.

High-throughput screening in mAb DSP typically uses resin slurry plates or mini-column formats. Resin slurry plates enable broad condition testing with low capital needs and flexible operating ranges, making them well-suited for early scouting. Mini-columns, including pre-packed formats, offer more representative chromatography behavior and support detailed comparison of resin performance under defined process conditions.

Improving mAb recovery during capture requires balancing binding capacity with conditions that promote selective elution of impurities. MabCaptureC resin supports this balance through its high dynamic binding capacity and robust, alkaline-tolerant ligand. Pairing the resin with structured buffer optimization, such as evaluating pH, conductivity, and wash conditions, helps refine recovery while maintaining effective reduction of HCPs, aggregates, and other early-stage contaminants.

Scaling mAb purification requires confirming that resin performance, buffer use, and chromatographic behavior remain predictable as column dimensions and equipment change. Screening plates and small pre-packed columns help define conditions that translate reliably to larger formats. POROS resins, designed for consistent mass transfer across scales, support a smooth transition from development studies to clinical or commercial manufacturing.

High-titer feeds can increase aggregates, charge variants, HCPs, and residual DNA, placing more pressure on polish operations. Using AEX, CEX, ion exchange chromatography (IEX), and HIC resins allow targeted reduction of these species under defined pH and conductivity ranges. The Resin Selection Tool helps match resin chemistry with impurity profiles, supporting efficient reduction strategies as conditions scale or shift.

There are generally two instances where non-ProA affinity resins targeting other antibody subdomains are worth evaluating. Sometimes the structure of non-traditional antibody-based therapeutics, such as bispecifics and Fab fragments, has altered ProA binding sites and recovery can be an issue, or using different affinity resins can offer enhanced selectivity between target and misformed pairs or aggregates. In addition, feedstreams of these advanced modalities are often more complex than those of traditional mAbs, containing more difficult to remove impurities. Employing different affinity resins at the capture step can help reduce the product-related impurity burden on subsequent steps.