Various unit operations are needed in downstream processing (DSP) of biologics to remove process‑related impurities such as host‑cell proteins, nucleic acids, viruses, and endotoxins. This application note describes the potential of a salt‑tolerant anion‑exchange resin to achieve outstanding clearance of endotoxins and viruses. Introduction Endotoxins are lipopolysaccharides (LPS) originating from cell membranes of Gram‑negative bacteria. They are frequent contaminants of recombinant proteins produced in microbial expression systems. On the other hand, expression of more complex proteins in eukaryotic systems carries…
Author Archives: Regina Römling
MAb Aggregate Removal Through Ion-Exchange Chromatography: In Bind/Elute and Flow-Through Mode with TOYOPEARL NH2-750F
A polishing step for the purification of a monoclonal antibody (MAb) using TOYOPEARL NH2-750F was developed. In general, anion-exchange resins can be used in bind and elute (B/E) mode as well as in flow- through (FT) mode. Both options were evaluated. To increase the amount of aggregates of the test sample, a MAb was aggregated by acidic incubation and subsequently diluted to 1Â g/L in loading buffer. Read the full text of this application note in the PDF (Login required).
Protein A Chromatography with High-Titer Feedstocks
Protein A chromatography has become a widely used platform in monoclonal antibody (MAb) purification. We describe the impact of higher MAb loadings on aggregation and ligand leaching during protein A chromatography, as well as the benefits of high-capacity Protein A resins for high-titer feedstocks. Today, high MAb titers achieved through advanced upstream processing have become a challenge for downstream processing, especially with regards to the expensive protein A capturing step. TOYOPEARL AF-rProtein A HC-650F provides superior MAb capacity and beneficial…