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Process reagent clearance for biopharmaceutical products: A science-based perspective incorporating safety threshold

Pengxiao Zuo1, Hui Koon Khor1, Soumitra Bhoyar1

  • 1Process Development, Amgen Inc.

Journal of Pharmaceutical Sciences
|September 26, 2026
PubMed

Keywords:
CMC S32 ImpuritiesProcess Reagent Clearance EvaluationProcess Reagent Clearance ModelingProcess-related ImpurityQualification Limit Threshold

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