Bioprocess
Amsphere™ A3 is a high capacity, next generation Protein A chromatography resin for advanced antibody purification with overall improved process robustness and optimized impurity removal.
Amsphere A3
Amsphere™ A3 is a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing.
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
Key value propositions of Amsphere™ A3
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.
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).
Regulatory documents
The manufacturing process of Amsphere™ A3 complies with all regulations that enable the usage of the final product for GMP compliant drug manufacturing. All raw materials including the polymeric beads and protein A ligand are manufactured within ISO certified manufacturing facilities owned by JSR.
The entire production process is free from animal-derived components and is certified BSE-TSE Free.
The Regulatory Support File is available under a Confidential Disclosure Agreement (CDA).
Pre-Packed formats
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.
Validated Protein A Leaching Kit by Cygnus Technologies
An Amsphere™ A3 ligand specific ELISA kit is available through Cygnus Technologies. Please click here to order the kit.
