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Targeted CQA analytical control strategy for commercial antibody products: Replacing ion-exchange chromatography methods for charge heterogeneity with multi-attribute monitoring
Adam R. EvansTherapeutics Development & Supply - Analytical Development, Janssen Pharmaceuticals Research and Development, Malvern, PA, USACorrespondence[email protected]
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Joseph MulhollandTherapeutics Development & Supply - Analytical Development, Janssen Pharmaceuticals Research and Development, Malvern, PA, USAView further author information
, Michael J. LewisTherapeutics Development & Supply - Analytical Development, Janssen Pharmaceuticals Research and Development, Malvern, PA, USAView further author information
& Ping HuTherapeutics Development & Supply - Analytical Development, Janssen Pharmaceuticals Research and Development, Malvern, PA, USACorrespondence[email protected]
https://orcid.org/0000-0001-7694-222XView further author information
https://orcid.org/0000-0001-7694-222XView further author information
Article: 2341641
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Received 05 Feb 2024, Accepted 08 Apr 2024, Published online: 23 Apr 2024
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