Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
News|Articles|September 22, 2023
Simplifying Bioreactor In-Process Monitoring with Waters Bioprocess Walk-Up Solutions
Author(s)Waters
Bioprocessing for protein production is a time-consuming process, typically lasting about two weeks. It is increasingly desirable to routinely monitor critical process and product attributes such as changes in nutrient profiles and high level glycoform information for the drug substance. Read our latest application note to learn how the newly launched bioprocess walk-up solutions enable bioprocess engineers to collect attributes easily and rapidly for process related monitoring and optimization using the Andrew+ Pipetting Robot, Waters OneLab Software and the BioAccord LC-MS System.
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