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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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
& Minimize Costs
Excellent
Impurity Clearance
Webinar
Development of effective purification process for bispecifics using affinity capture and mix-mode polishing chromatography
KBI Biopharma and JSR Life Sciences have developed processes for the purification of BsAbs utilizing Amsphere A3 affinity chromatography followed by two polishing steps to eliminate undesirable homodimers and other impurities.
Amsphere A3’s superior binding capacity, resin lifetime, and caustic stability can provide a cost effective, supply-chain stable purification strategy when paired with well-designed polishing steps. In addition to A3 affinity capture, KBI’s platform BsAb purification process includes mixed-mode anion exchange and cation exchange to eliminate homodimeric impurities.
Presenter: Hunter Reese Ph.D.
Scientist, KBI Biopharma Inc.