This guideline aims to support biopharmaceutical manufacturers in the transition from MabSelect SuRe™ LX or MabSelect SuRe™ resins to include MabSelect™ PrismA resin in the capture steps of new mAb development projects.
This document provides a guideline for transitioning from MabSelect SuRe™ LX or MabSelect SuRe™ resins to the next-generation MabSelect™ PrismA resin for the capture of monoclonal antibodies and Fc-containing recombinant proteins. MabSelect PrismA features a rigid, high-flow agarose base matrix and an alkaline-stabilized ligand derived from protein A, offering increased capacity and alkaline stability compared to its predecessors.
Key considerations for a successful transition include upgrading immunoassays to quantify leached ligand, adjusting column packing methods to adapt to updated pressure-flow properties, addressing increased mass throughput in polishing steps, and implementing improved cleaning and sanitization protocols due to higher alkaline stability.
| Matrix | Highly cross-linked agarose, spherical |
|---|---|
| Ligand | Alkaline-stabilized protein A-derived (E. coli) hexamer |
| Coupling chemistry | Epoxy |
| Particle size d50v | ~ 60 µm |
| Dynamic binding capacity QB10 | ~ 80 mg human IgG/mL resin at 6 min residence time |
| Maximum operating flow velocity | 300 cm/h (4 min residence time) |
| pH stability (CIP) | 3–12 |
MabSelect PrismA features an optimized base matrix and ligand for increased capacity and alkaline stability compared to MabSelect SuRe.
Yes, the MabSelect PrismA ligand is produced in E. coli and is free of animal-derived components.
The ligand concentration of MabSelect PrismA is higher than for MabSelect SuRe, which can result in increased ligand leaching.