| Chromatography technique | Antibody affinity chromatography |
|---|---|
| Binding Capacity/ml Chromatography Medium | Approx. 40 mg humanlgG/mL at 2.4 min residence time |
| BioProcess resin | Yes |
| Certificate of Analysis | Yes |
| Ligand | Recombinant protein A (E.coli) |
| Ligand Coupling Method | Epoxy activation |
| Matrix | Highly cross-linked agarose |
| Particle size, d 50V | ~75 µm |
| Pressure/Flow Specification | < 300 cm/h, < 200 kPa, BPG 300, bed height 20 cm |
| Storage | 2 to 8°C, 20% Ethanol |
| pH stability, CIP | 2–12 |
| pH stability, operational | 3–10 |
Answer:Protein A affinity capture of compatible monoclonal antibodies and other Fc-containing targets.
Answer:No. It is a 5 L bulk resin pack for filling a suitable chromatography column.
Answer:A validated change in elution conditions, commonly a controlled acidic elution, releases the antibody from the ligand.
MabSelect Xtra Protein A Chromatography Resin is an affinity medium designed for capture purification of monoclonal antibodies from clarified bioprocess feedstocks. Its immobilized protein A ligand binds the Fc region of compatible immunoglobulins, enabling selective recovery of antibodies during a capture chromatography step. The resin is designed for high dynamic binding capacity and helps process concentrated antibody feeds while reducing the number of cycles required for a given batch. This 5 L bulk pack supports column packing, scale-up and process development rather than representing a prepacked cartridge. Establish operating conditions with a suitable equilibration and loading buffer, then optimize washing and elution to control host-cell proteins and other impurities. Monitor pressure, flow and recovery during use, especially after repeated cleaning cycles. Product quality also depends on feedstock preparation, residence time and column packing consistency. Evaluate ligand compatibility, cleaning chemistry and leachate requirements within the process validation plan. The resin is intended for affinity capture and is not a size-exclusion or ion-exchange medium.
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