Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies and their suppliers must collaborate. To meet this challenge, GE Healthcare is committed to continuous improvement of its chromatography resins to enable delivery of products without detectable bioburden. For example, development of Protein A resins to withstand high NaOH concentrations…
Author Archives: Anna Gronberg
Three-Step Monoclonal Antibody Purification Processes Using Modern Chromatography Media
This application note describes a monoclonal antibody (MAb) purification process using the expanded MAb purification toolbox of GE Healthcare’s Life Sciences business, covering modern chromatography media (resins) for standard and challenging purification tasks. The most established approach for purifying MAbs is a three-step process, where the initial capture step using a protein A medium is followed by two polishing steps using cation- exchange (CIEX) and anion-exchange (AIEX) media (Figure 1a). However, for more challenging MAb purifications, an expanded MAb purification…