Why use 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 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).

• 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.