Kang Cai, Jennifer Anderson, Etienne Utiger, Gisela Ferreira
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Viral clearance capability of monoclonal antibody purification
Viral clearance steps are routinely included in monoclonal antibody purification processes to safeguard product from potential virus contamination. These steps are often experimentally studied using product-specific feeds and parameters for each project to demonstrate viral clearance capability. However, published evidence suggests that viral clearance capability of many of these steps are not significantly impacted by variations in feed material or process parameter within commonly used ranges. The current investigation confirms robust retrovirus inactivation by low pH treatment and parvovirus removal by second-generation virus filters, independent to individual antibody molecules. Our results also reveal robust retrovirus removal by flowthrough anion exchange chromatography, inside the limits of protein load and host cell protein content. The cumulative viral clearance capability from these steps leads to an excess clearance safety factor of 10,000-fold for endogenous retrovirus-like particles. These results further justify the use of prior knowledge-based modular viral clearance estimation as opposed to repetitive experimentation.
期刊介绍:
Biologicals provides a modern and multidisciplinary international forum for news, debate, and original research on all aspects of biologicals used in human and veterinary medicine. The journal publishes original papers, reviews, and letters relevant to the development, production, quality control, and standardization of biological derived from both novel and established biotechnologies. Special issues are produced to reflect topics of particular international interest and concern.Three types of papers are welcome: original research reports, short papers, and review articles. The journal will also publish comments and letters to the editor, book reviews, meeting reports and information on regulatory issues.