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Ion-Exchange Membranes for the Fabrication of Reverse Electrodialysis Device
Published on: July 20, 2021
A novel primary amine-based anion exchange membrane adsorber
Maybelle Woo1, Navid Z Khan, Jonathan Royce
1Millipore Corp., 80 Ashby Road, Bedford, MA 01730, USA. maybelle.woo@merckgroup.com
Journal of Chromatography. A
|April 23, 2011
Summary
A new anion exchange membrane adsorber effectively removes DNA, endotoxin, and virus impurities from protein purification processes, even at high salt concentrations. This technology offers improved performance and linear scalability for biopharmaceutical manufacturing.
Area of Science:
- Biotechnology
- Chemical Engineering
- Separation Science
Background:
- Current purification methods for biopharmaceuticals face challenges with impurity removal, especially under varying salt conditions.
- Existing membrane adsorbers and resins may not offer optimal performance for critical impurity clearance in monoclonal antibody (mAb) and recombinant protein purification.
Purpose of the Study:
- To develop and evaluate a novel anion exchange membrane adsorber with enhanced impurity binding capacity at high salt concentrations.
- To assess the performance of this membrane adsorber for the removal of DNA, endotoxin, and virus in biopharmaceutical feedstocks.
- To demonstrate the scalability of the membrane adsorber device for industrial applications.
Main Methods:
- A novel anion exchange membrane adsorber functionalized with a primary amine ligand (polyallylamine) was synthesized.
- Impurity removal studies were conducted using spiked buffers with varying conductivities (2-27 mS/cm) and target molecules (DNA, endotoxin, virus).
- Virus removal was verified in actual monoclonal antibody (mAb) feedstocks.
- A stacked flat-sheet design was used to evaluate linear scalability with bovine serum albumin (BSA) as a model contaminant.
Main Results:
- The membrane adsorber demonstrated excellent impurity removal across a wide range of buffer conductivities (2-27 mS/cm).
- Achieved clearance levels of >3, 4, and 4 Log Reduction Values (LRV) for DNA, endotoxin, and virus, respectively, with minimal impact from increasing salt concentrations.
- Virus removal was confirmed in mAb feedstocks, and the stacked device showed linear scalability of performance.
Conclusions:
- The primary amine-functionalized membrane adsorber offers superior purification performance compared to traditional chemistries for critical impurity removal.
- The technology provides effective and consistent removal of DNA, endotoxin, and virus, even at high salt concentrations.
- The linearly scalable device represents a significant advancement in polishing technology for monoclonal antibodies and recombinant proteins.
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