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Safety risk management for low molecular weight process-related impurities in monoclonal antibody therapeutics: Categorization, risk assessment, testing strategy, and process development with leveraging clearance potential.
Luo H, Li Y, Robbins D, Wang SC, Xi G, Cox M, Nicholson SM, Wei C, Pabst TM, Wang WK. Luo H, et al. Among authors: li y. Biotechnol Prog. 2021 May;37(3):e3119. doi: 10.1002/btpr.3119. Epub 2021 Jan 6. Biotechnol Prog. 2021. PMID: 33373106 Free PMC article.
Virus removal robustness of ion exchange chromatography.
Cai K, Anderson J, Orchard JD, Afdahl CD, Dickson M, Li Y. Cai K, et al. Among authors: li y. Biologicals. 2019 Mar;58:28-34. doi: 10.1016/j.biologicals.2019.01.004. Epub 2019 Jan 18. Biologicals. 2019. PMID: 30661901
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