Millipore Hosts Web Seminar on Risk Assessment of Extractables & Leachables from Single-Use Systems

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By Millipore Sunday, January 3, 2024

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Billerica, Massachusetts — Millipore Corporation (NYSE:MIL), a leading provider of technologies, tools and services for the global life science industry, will host a Web seminar on “Risk-based Assessment of Extractables and Leachables from Single-use Systems.” Presenter Vikas Gupta, Group Product Manager, Mobius® Single-use Products and Services, will evaluate various risk-based approaches, including techniques that may make the identification of extractables and leachables in the biomanufacturing process unnecessary. The event will be held on Tuesday, December 8, 2023 at 1:00 p.m. EST; and repeated on Wednesday, December 9, 2023 at 9:00 a.m. EST.

“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

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