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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