GMPs/Validation Whitepapers - BioPharm International


GMPs/Validation Whitepapers

Novel pH Gradient Separation Platform for Monoclonal Antibody Charge Variant Analysis

July 30, 2013

A novel pH gradient method for cation-exchange chromatography is discussed. Linear pH gradient was achieved using a multi-component buffer system containing multiple zwitterionic buffer species with pI values from 6 to 10.

High-resolution Analysis of Charge Heterogeneity in Monoclonal Antibodies Using pH-gradient Cation Exchange Chromatography

June 25, 2013

The authors describe pH-based separation of acidic and basic charge variants for mAbs using the Agilent 1260 Infinity Bio-inert Quaternary LC System and an Agilent BioMAb PEEK 4.6 x 250 mm IEX column, featuring a special particle coating designed for charge-based separation of MAbs.



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