Author Archives: Sanchayita Ghose

Understanding Viral Clearance During Anion-Exchange Chromatography: A Novel Design of Experiments Approach

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Anion-exchange (AEX) chromatography is a well-established polishing step for removal of viruses and other impurities during downstream processing of biotherapeutics. Before initiating phase 1 clinical trials, a representative scaled-down model of the final process must be available for use in viral-clearance studies. At that point, however, scientists usually have no way of knowing how effective a process will be for removing viruses. In this article, scientists from Thermo Fisher Scientific and Bristol Myers Squibb (BMS) describe their efforts to define…

May 2, 2023

Hollow-Fiber Nanofiltration for Robust Viral Clearance of Non-MAb Biologics

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Monoclonal antibody (MAb) and other therapeutic biologics produced by mammalian cells have the potential to introduce endogenous retroviruses and can be infected with adventitious viruses through raw materials or other parts of the biomanufacturing process (1–3). Based on regulatory guidelines, products derived from mammalian cells must contain less than one virus particle per million doses, which requires purification processes to demonstrate virus removal capabilities of about 12–18 log10 clearance of endogenous retroviruses and 6 log10 clearance for adventitious viruses (4).…

December 12, 2022

Scale-Up of Twin-Column Periodic Countercurrent Chromatography for MAb Purification

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Periodic countercurrent (PCC) processes increasingly are being evaluated as alternatives to single-column batch capture processes. Some of the advantages of PCC processes over single-column processes include shortening of processing time and/or reduction of required resin volume through increased productivity; reduction in resin costs through improved resin capacity use; and reduction in buffer consumption through increased column loading. Those advantages, however, come with increased equipment complexity and hardware costs. PCC processes and systems with two to up 16 columns of the…

April 20, 2018