Elemental Metal Variance in Cell Culture Raw Materials for Process Risk Profiling

This article describes an analytical technique applying Inductively Coupled Plasma Mass Spectrometry (ICP ‐MS) to characterize a list of common raw materials and media powders used in mammalian cell culture and therapeutic protein production. We aim to describe a method qualification approach suitable for biopharmaceutical raw materials. Furthermore, we present detailed profiles of many common raw mat erials and discuss trends in raw material subtypes. Finally, a case study demonstrating the impact of an unexpected source of raw material variation is presented along with recommendations for raw material elemental risk profiling and control.
Source: Biotechnology Progress - Category: Biotechnology Authors: Tags: RESEARCH ARTICLE Source Type: research