Viral Clearance: Safety and Efficiency of Biopharmaceuticals

Viral clearance is a vital procedure in the pharma industry, safeguarding the well-being of drug products by eradicating or inactivating possible viral toxins while manufacturing. This includes a multifaceted method, along with laborious testing of raw materials, process design, optimization, and validation studies to demonstrate the effectiveness of viral clearance steps. Nowadays, this topic has become more challenging and versatile with the development of new viruses in the environment. This manuscript focuses on the potential routes of viral contamination, including viral impurities present in the master cell bank, and contaminated virus introduced during manufacturing, adventitious viruses from raw materials, principles of viral clearance, regulatory framework, design of viral clearance studies interpretation and limitations, emerging technologies and trends, viral clearance strategies such as inactivation methods: low pH, solvent/detergent, heat treatment and removal methods like chromatography, nanofiltration, precipitation and related case studies.