“Risk assessment is a critical component of an extractables and leachables evaluation, and each project is unique,” said Gupta. “Yet there is limited regulatory guidance that directly addresses extractables and leachables from single-use systems used in the bioprocessing industry. This webinar will help attendees understand the pros and cons of the various options available to them.”

During the presentation, Gupta will review regulatory guidelines that can be used to conduct a risk-based assessment of extractables and leachables evaluations. He will also present case studies that highlight the pragmatic use of risk-based assessment of extractables and leachables in single-use systems.

“Adopting single-use technologies in product-contact applications, such as ultrafiltration/diafiltration, bulk drug substance storage, and final fill and finish, requires a detailed analysis of the risks posed by extractable and leachable particles,” said Gupta, who has delivered presentations on the subject at a number of industry conferences. “As a result of Millipore’s extensive experience in developing single-use products and services, we are uniquely qualified to help biomanufacturers understand current thinking and best practices on the subject.”

For information on registering for the webinar program hosted by Millipore, please visit www.millipore.com/reply/form/mobius-guptawebinar

About Millipore
Millipore (NYSE: MIL) is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world’s challenging human health issues. From research to development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Millipore Corporation is an S&P 500 company with more than 5,900 employees worldwide. For more information, please contact Millipore Tech Service at 1-800-548-7853 or 951-676-8080 or visit www.millipore.com.

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Millipore Media Contact:
Janice Paquette
Global Director of Communications
Bioprocess Division
781-533-5197
Janice_Paquette@Millipore.com

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