Amsphere™ A3

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.

Resources

• Application Notes

  Six Biosimilar Molecules

  Competitive Comparison

  Buffer Selection Study

  Packing Protocol

  Lifetime Study

  Product Overview

  Cycling Study

  Antibody Fragments

  Viral Clearance Studies

• Posters

  Purification of Antibody Fragments

  Optimization of a Protein A Chromatography Process for a Herceptin® Biosimilar

  Qualitative analysis by 2D-LC/MS of remaining HCPs post Protein A chromatography

• Whitepapers

  White Paper: Purification of antibody fragments and single domain antibodies with Amsphere A3

• Webinars

  Protein A Resin for Antibody Fragment Purification

  Effective Implementation of Amsphere A3 in Development & Manufacturing

Product Lineup

• North America & EMEA Regions

  
  

  

  
  

• APAC Region

   

  

  

  
  

   

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

  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 & 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.