Amsphere™ A3 is a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing.

Current A3 Programs
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Phase I
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BLA
Commercial Programs 1
How Can Amsphere™ A3 Help Me?
Besides an outstanding high capacity, Amsphere™ A3 has an overall improved process robustness, flow characteristics, optimized impurity removal, productivity and resin lifetime.
Protein A Ligand High DBC via controlled conformation and orientation High alkaline stability from protein engineering |
Surface modification Low HCP levels by surface hydrophilization |
Base bead formulation High DBC at high flow rate Good pressure and flow properties via rigid crosslinking |
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Catalog Numbers & Product Sizes
Why use Amsphere™ A3?
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Outstanding Dynamic Binding Capacity
A highly cross-linked bead structure and controlled attachment of the protein A ligand results in a superior dynamic binding capacity.
At higher flow rates the semi-rigid bead structure allows to achieve up to 50% higher DBC compared to the market standard product at low to moderate residence times of 2-6 minutes. -
Impurity Clearance At Industry Standard
The surface treatment of the polymeric base matrix resulted in low HCP, DNA, virus and aggregate levels that are very similar to hydrophilic backbones such as agarose.
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Superior Caustic Stability
Amsphere™ A3 can resist up to 300 cycles with 0.1 M sodium hydroxide as CIP solution (15 minutes of contact time) while maintaining a dynamic binding capacity above 90%. In addition, 0.5 M sodium hydroxide can be used for at least 100 cycles (15 minutes of contact time).
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Regulatory Compliance
- Amsphere™ A3 resin manufacturing, testing, packaging, storage, and distribution are all done in accordance with ISO9001 standards and certified.
- All raw materials used in the manufacturing process of Amsphere™ A3 are evaluated and free of animal-derived substances and are considered safe regarding BSE/TSE risk.
- Amsphere™ A3 resin is used in the biopharma industry for the GMP manufacturing process of clinical and commercially approved biologics.
- The Regulatory Support File is available under a Confidential Disclosure Agreement (CDA).
- Amsphere™ A3 resin manufacturing, testing, packaging, storage, and distribution are all done in accordance with ISO9001 standards and certified.
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Pre-Packed Formats & Validated Protein A Leaching Kit
Ready-to-use pre-packed RoboColumn®s (200 – 600 µL) and small scale 1 mL and 5 mL columns are available for screening purposes and process development. Larger formats including GMP compliant pre-packed columns are also available on request.
An Amsphere™ A3 ligand specific ELISA kit is available through Cygnus Technologies. Please click here to order the kit.
Why Amsphere A3 is an Outstanding Choice for Antibody Fragment & FC-Fusion Purification
Universal Affinity Resin for
Simplify Your Supply Chain
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Excellent
Impurity Clearance
Upcoming Webinar
Resin Replacement Study Using JSR Amsphere A3 and a Platform Resin to Reduce the Supply Risk of Protein A Resin
This webinar will demonstrate a comparison of A3 and MabSelect SuRe LX resin performance in test processing of two different IgG1 targets via affinity chromatography, flow-through anion exchange and capture cation exchange chromatography. The data indicates that A3-based processing offers similarly fine performance of yield (80% total), host cell protein clearance, ligand leaching, and aggregate removal. We will also review mass spectrometry analysis of host cell protein clearance by the various process operations.