Viral Clearance Strategies in Biopharmaceutical Manufacturing

This article presents a detailed examination of viral clearance strategies in biopharmaceutical manufacturing, focusing on monoclonal antibodies (mAbs). It outlines the critical importance of viral safety in the production process, particularly due to the use of mammalian cell lines that are susceptible to viral contamination. The article discusses various downstream processing (DSP) techniques, including chromatographic methods such as Protein A affinity, ion exchange, and mixed-mode chromatography, which are employed to enhance viral removal. Additionally, it highlights dedicated viral inactivation steps, such as low-pH incubation and detergent treatment, which are effective against enveloped viruses. The article also addresses the role of virus filtration as a robust barrier to small viruses and introduces emerging solutions like activated carbon filtration. Furthermore, it emphasizes the integration of viral clearance strategies into continuous downstream workflows, ensuring compliance with regulatory standards and enhancing the safety of biopharmaceutical products. Overall, the article serves as a comprehensive resource for understanding the complexities of viral clearance in biomanufacturing.