Semi-quantitative screening of metals in biopharmaceuticals - ICP-MS generic method

USP <1023>, edited in August 2024, describes the evaluation strategy for trace elements in cell culture media used in the manufacture of recombinant proteins therapeutic. The chapter highlights potential issues related to trace element contamination and the need for monitoring, without providing technical recommendations.

To support investigative, diagnostic, and exploratory analyses, we developed a screening method for the rapid detection of 60 potential elemental contaminants without requiring a predefined target list or extensive method development. Using ICP-MS, the approach provides high-sensitivity screening and broad elemental coverage, delivering approximate concentrations that help identify anomalous elemental levels and elements of potential toxicological or quality concern.

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