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USP Standards to Support Qualification of Raw Materials and Cell Substrates for Biomanufacturing


Maura Kibbey, Ph.D. (Director, Global Biologics, USP)

Location: 108A

Date: Wednesday, April 25

Time: 11:30am - 12:15pm

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Bio-Processing Symposium

Vault Recording: TBD

The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents.

This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.