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.
|Articles|October 27, 2020
Upstream Process Development with a kʟa Criterion
Author(s)Distek, Inc
It can be challenging to define suitable operational definitions for volume-dependent parameters for upstream bioprocesses. In this work, we perform robust DoE mass-transfer characterization of the BIOne SUB and utilize a kʟa criterion to successfully define such parameters for a HEK-293 process.
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