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.
Join Kristi Haskins, our Group Lead & Staff Scientist, for a webinar to learn more about how our modern protein A resin, Amsphere A3, can be effectively implemented in process development and manufacturing.
Part of the free PREP Symposium Webinar Series