Capto™ S ImpAct ion exchange chromatography resin

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.

Capto S ImpAct resin is available in bulk container formats and in prepacked chromatography formats, to support various scales, from screening to GMP manufacturing. process development.

Typical chromatogram demonstrating capabilities for aggregate and host cell protein removal at high load (64 mg/mL) with linear salt gradient elution.

Schematic picture of the polymer-grafted Capto™ S ImpAct resin. The polymer surface extender is formed by random grafting between the two building blocks

Typical mAb purification process with a protein A affinity capture step, followed by two polishing steps

Capto™ S ImpAct ion exchange chromatography resin

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.

Pack size

1 L

5 L

10 L

25 mL

60 L

100 mL

Capto™ S ImpAct resin

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Overview

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.

Product specifications

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17371701

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261.00 USD

17371703

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5,242.00 USD

17371702

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776.00 USD

17371704

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On request

17371705

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On request

17371760

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On request

Product availability is not guaranteed and subject to change.

Product Support

FAQ

Ligand

Question	Answer
What is the advantage with a polymeric ligand design?	With the polymeric design, the ligand includes both spacers and functional groups. This increases the binding capacity without compromising the resolution.

Performance

Question	Answer
Is there any data showing Capto™ S ImpAct resin used as the second step in a mAb purification process?	Application note CY13612 Polishing of monoclonal antibodies using Capto™ S ImpAct includes an example of a chromatography step with Capto™ S ImpAct resin. The data file CY11840 includes dynamic binding capacity (DBC), application examples, and links to additional application notes.
How to optimize Capto™ S ImpAct resin?	For screening of a wide range of buffer conditions we recommend prepacked 96-well filter PreDictor™ plates or PreDictor™ RoboColumn, prepacked miniaturized columns. Further optimization is preferably done in laboratory-scale columns before scale-up. An example is given in CY13646.

Comparison with Capto™ S and Capto™ SP ImpRes resins

Question	Answer
What are the design and performance differences between Capto™ S ImpAct, Capto™ SP ImpRes, and Capto™ S resins?	Capto™ S ImpAct resin is a polishing resin with surface-extender technology for large molecules (mAbs) and for high capacity in combination with high resolution (even at high load). Capto™ SP ImpRes resin is a polishing resin suitable for smaller proteins that require high resolution. Capto™ S resin is a capture resin for high capacity and good pressure/flow properties. All three resins are comparable in terms of ligand leakage, alkali stability, and acidic stability.
Can the same buffer systems be used for binding and elution with Capto™ S, Capto™ SP ImpRes, and Capto™ S ImpAct resins?	Yes, the same buffer systems can be used for Capto™ S ImpAct as for Capto™ S and Capto™ SP ImpRes resins. Capto™ S ImpAct is a cation exchange (CIEX) resin and can be used as any other CIEX resin.
Capto™ S resin had some nontraditional behavior. Could similar behavior be expected with Capto™ S ImpAct resin?	Not to the same extent, but in some cases, yes. We recommend screening of pH and salt conditions to evaluate each protein that is going to be purified.

Question

Answer

What are the design and performance differences between Capto™ S ImpAct, Capto™ SP ImpRes, and Capto™ S resins?

Capto™ S ImpAct resin is a polishing resin with surface-extender technology for large molecules (mAbs) and for high capacity in combination with high resolution (even at high load).
Capto™ SP ImpRes resin is a polishing resin suitable for smaller proteins that require high resolution.
Capto™ S resin is a capture resin for high capacity and good pressure/flow properties.

All three resins are comparable in terms of ligand leakage, alkali stability, and acidic stability.

Can the same buffer systems be used for binding and elution with Capto™ S, Capto™ SP ImpRes, and Capto™ S ImpAct resins?

Yes, the same buffer systems can be used for Capto™ S ImpAct as for Capto™ S and Capto™ SP ImpRes resins. Capto™ S ImpAct is a cation exchange (CIEX) resin and can be used as any other CIEX resin.

Capto™ S resin had some nontraditional behavior. Could similar behavior be expected with Capto™ S ImpAct resin?

Not to the same extent, but in some cases, yes. We recommend screening of pH and salt conditions to evaluate each protein that is going to be purified.

Column packing

Question	Answer
Are there available packing instructions for laboratory-scale Tricorn™ and HiScale™ columns and bioprocess columns?	Yes, large scale packing instructions are found in the article Packing large-scale chromatography columns with Capto™ S ImpAct resin. Packing of lab scale, Tricorn™ and HiScale™ columns, are included in 29092501 Capto™ S ImpAct Ion Exchange Media Instructions for Use.
What is the packing factor of Capto™ S Impact?	For a 20 cm bed in 150 mM NaCl when consolidated at 60 cm/h, the packing factor is 1.20.

Pressure

Question	Answer
What is the maximum pressure for Capto™ S Impact?	Maximum back pressure over the packed bed is 3 bar (44 psi, 0.3 MPa) for HiTrap™ columns and 4 bar (58 psi, 0.4 MPa) for HiScreen™ columns.

Cleaning and sanitization

Question	Answer
What cleaning procedures should be used for Capto™ S ImpAct resin?	The instruction for use (29092501) includes guidance on how to remove specific contaminants.
How to do sanitization of Capto™ S ImpAct resin?	Regular sanitization will hinder microbial growth and maintain a high level of hygiene in the packed column. A specific sanitization protocol should be developed according to the nature and condition of the starting material. To reduce microbial contamination in the packed column, sanitization using 0.5 to 1 M NaOH with a contact time of 1 h is recommended. The clean in place (CIP) protocol for precipitated, hydrophobically bound proteins or lipoproteins sanitizes the resin effectively.

Question

Answer

What cleaning procedures should be used for Capto™ S ImpAct resin?

The instruction for use (29092501) includes guidance on how to remove specific contaminants.

How to do sanitization of Capto™ S ImpAct resin?

Regular sanitization will hinder microbial growth and maintain a high level of hygiene in the packed column. A specific sanitization protocol should be developed according to the nature and condition of the starting material.
To reduce microbial contamination in the packed column, sanitization using 0.5 to 1 M NaOH with a contact time of 1 h is recommended. The clean in place (CIP) protocol for precipitated, hydrophobically bound proteins or lipoproteins sanitizes the resin effectively.

Storage

Question	Answer
Can you provide some storage recommendations not using ethanol?	We recommend 2% benzyl alcohol with 0.2 M sodium acetate.
What is the shelf life for Capto™ S ImpAct products?	The shelf life is estimated to be 5 years for Capto™ S ImpAct resin in bulk.

Antibody purification

Question	Answer
Which resin to use in mAb and antibody variant purification?	Our recommendation is to start with our platform for antibodies. MabSelect™ PrismA➔Capto™ S ImpAct➔Capto™ Q or Mustang™ Q. However, depending on what purification challenges the process may need to be fine-tuned. To learn more about options in capture, look at the capture selection guide. You can read more about polishing in this article and in the polishing selection guide.