Ushma Mehta

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MilliporeSigma
Regulatory Consultant
Ushma Mehta is a Regulatory Consultant for continuous intensified process and cell therapy at MilliporeSigma. She has over 15 years of experience in the life sciences and bioprocessing. Ushma has published peer-reviewed papers on virus removal strategies in both batch process and continuous intensified processing. She has a broad range of experience as a virology scientist in designing and executing virus clearance and inactivation studies across different unit operations of monoclonal antibody and recombinant protein purification templates. She holds a BS and a MS in microbiology, analytical, and medicinal chemistry (Mumbai, India) and completed a graduate certificate course in biopharmaceutical international regulatory affairs at Northeastern University. Ushma joined ISPE in 2020.

Related Articles

Figure 1: Batch manufacturing process vs. a low pH iVI process.
Technical
Continuous Process: Implementing Low pH Viral Inactivation in a Continuous Process

Viral inactivation (VI) is a critical step in ensuring the safety of monoclonal antibody (mAb), Fc fusion, and recombinant protein therapeutics and it is typically an important component of an overall virus control strategy for downstream biotherapeutic production processes. Considerations for successful implementation of an inline VI process are discussed in this article.