Cytiva, 17371703, Capto™ S ImpAct ion exchange chromatography resin

Capto S ImpAct, 1 L Capto™ S ImpAct chromatography resin is a strong cation exchanger designed for polishing of monoclonal antibodies (mAbs), antibody variants, and a wide range of other biomolecules. • High binding capacity, typically > 100 mg mAb/mL resin. • Efficient aggregate removal at high load of mAbs. • High-resolution polishing. • Flexibility of design: large operational window of flow rates and bed heights for easy optimization and scaling. • High productivity, enabling cost-efficient manufacturing. Capto™ S ImpAct resin is a strong cation exchange resin that is designed for purification of antibodies including bispecific antibodies and antibody fragments. At high load it has shown capabilities of removing aggregates, host cell proteins, and product-related impurities such as charge variants while achieving high recoveries of the target molecule. If you want to evaluate Capto™ S ImpAct resin for developing your antibody process, contact us to request a sample . A resin designed for polishing of mAbs and antibody variants in GMP environments The properties of Capto™ S ImpAct enable a highly efficient chromatography step for polishing purification of monoclonal antibodies and antibody variants including bispecific antibodies and antibody fragments. As a second or third chromatography step it can remove impurities such as aggregates, host cell proteins, and product-related impurities such as charge variants or fragments in bind and elute mode. Effective impurity removal and high recoveries can be achieved with loads > 50 mg/mL. Capto™ S ImpAct is a bioprocess chromatography resin manufactured with validated methods for use in biopharmaceutical production processes. Regulatory support files are available to assist process validation and submissions for regulatory authorities. The manufacturing plant of Capto™ S ImpAct resin is certified for business continuity management (ISO 22301) for continuous reliable supply. Capto™ S ImpAct resin combines high flow rate, high resolution, and high binding capacity Capto™ S ImpAct resin includes a polymer-grafted ligand with negatively charged sulfonate and neutral pyrrolidone building blocks. The combination of the groups creates a functionalized surface extender with high binding capacity. The base matrix is based on 50 µm bead size high-flow agarose with optimized pores to give high resolution. The rigid base matrix enables seamless scale up to a reliable and robust chromatography step for large-scale industrialized purification processes. Capto™ S ImpAct resin is available in the following formats (Fig 1):

Format	Description
Capto™ S ImpAct resin	Bulk resin bottles and containers designed for column packing.
PreDictor™ Capto™ S ImpAct RoboColumn units	Miniaturized columns for high-throughput process development (HTPD).
PreDictor™ Capto™ S ImpAct multiwell plates	96-well plates for high-throughput screening or process development.
HiTrap™ Capto™ S ImpAct columns	Optimized for screening and small-scale protein purification.
HiScreen™ Capto™ S ImpAct columns	Optimized for method and process development.
Validation column with Capto™ S ImpAct	For scale-down studies such as viral clearance studies.
f(x) column for mechanistic modeling	Prepacked and precharacterized chromatography column for fast and accurate mechanistic modeling.
Process Characterization Kits Capto™ S ImpAct	Designed for studying the potential impact that resin ligand density might have on the process outcome.
ReadyToProcess™ Capto™ S ImpAct columns	Available in various sizes for scale-up and GMP manufacturing.

Fig 1. Prepacked chromatography formats available from Cytiva to support various scales, from screening to GMP manufacturing. Other resins for purifying mAbs and mAb variants An antibody purification process usually includes several chromatography steps. Check this quick guide to see our resin recommendations for the various steps in a mAb process.