Identifying Impurities In Gene Therapy With Santoshkumar Khatwani

October 24, 2023

In this episode of Evaluating Biopharma, host Ben Locwin speaks with Santoshkumar Khatwani, Director – Analytical Development, Late-Stage CMC Analytical Team Lead at Sangamo Therapeutics, about impurities in gene therapy processes and the ways to identify them. Khatwani discusses how to determine if these impurities are from the product, the process, or the host cell. He also talks about using multiple different analytical methods to help understand how good your process is or isn’t, what to look out for when prioritizing by phase, and how to choose the best approach to measure process attributes. Finally, he shares his thoughts on leveraging data to its fullest potential to improve processes and how data can provide a more holistic view of how the process is performing.

GUEST BIO

Santoshkumar Khatwani, Director – Analytical Development, Late-Stage CMC Analytical Team Lead, Sangamo Therapeutics
Santosh is a subject matter expert in analytical method development and qualification/validation of analytical assays using qPCR, ddPCR, ELISA, HPLC, etc. for gene therapy drug substance and drug products. He is familiar with cGMP principles and regulatory (ICH, USP, FDA) guidelines, is experienced in managing assay development activities at CDMO and CTL and CRO. Santosh currently manages analytical support for in-house process development and manufacturing activities; has experience in building and leading cross functional teams while developing a variety of protein/enzyme-based colorimetric, fluorometric, luminescence, FRET, TR-FRET, Fluorescence Polarization/Anisotropy assays for RUO product development.

MODERATOR BIO

Ben Locwin, Vice President of Project Solutions, Black Diamond Networks
Ben Locwin is a healthcare executive and industry expert. His work has involved bringing new and innovative medical treatments (drug therapies, vaccines and medical devices) to patient populations with unmet needs across a variety of indications and health conditions. He has also worked with investors on the ‘next big things’ in the industry. He has been featured in The Wall Street Journal, Forbes, USA Today, The Associated Press, Axios, NPR, and other top-tier media.