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
Low HCP levels by surface hydrophilization
|Base bead formulation
High DBC at high flow rate
Good pressure and flow properties via rigid crosslinking
This video explains how to pack a column with our Amsphere™ A3 Protein A resin. It explains the small scale packing in an 1.6cm Diameter Column (HiScale™2 16/40).
2 HiScale™ is a trademark of GE Healthcare.
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.
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.
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).
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).
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.
KBI Biopharma Inc. has developed a rapid and streamlined workflow for comparing capacity and product quality from different ProA resin candidates as part of the larger downstream purification process development effort. This workflow has been utilized to compare Amsphere A3 resin to other high-performance Protein A resins available on the market since 2016. This presentation will cover the results of these comparisons in terms of ProA resin capacity and eluate product quality as well as later development data comparing viral clearance results for these different affinity resins.