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Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses
Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056