Abstract:
PEI, a cationic polymer, is widely used as a transfection reagent in the
manufacture of viral vectors and other biologics. Residual PEI is a critical
process-related impurity requiring sensitive and reliable monitoring to support
product safety, process consistency, and regulatory compliance. Despite its
importance, analytical control of PEI remains challenging.
To address these limitations, we developed a direct ultra performance liquid
chromatography (UPLC)- charged aerosol detection (CAD) method for
quantification of residual PEI.
This method utilizes a streamlined, modality-agnostic sample preparation
strategy that eliminates the need for copper chelation, thereby improving
specificity, accuracy, and robustness.
Authored by: Ramakrishna Battula,MS; Elnaz Nahari,PhD; Alaknanda Mishra,PhD, Mike Molloy, PhD, Jeff Heiser, BS
BA Sciences, Advanced Therapeutics Lab, Salem, New Hampshire 03079
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