Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.
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ABSTRACT:
SUBMITTER: Yandrofski K
PROVIDER: S-EPMC9117750 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
Publications
Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.
Yandrofski Katharina K Mouchahoir Trina T De Leoz M Lorna ML Duewer David D Hudgens Jeffrey W JW Anderson Kyle W KW Arbogast Luke L Delaglio Frank F Brinson Robert G RG Marino John P JP Phinney Karen K Tarlov Michael M Schiel John E JE
Frontiers in molecular biosciences 20220505
Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant features and critical quality attributes are maintained. A thorough understanding of analytical method performance metrics, particularly emerging methods designed to address measurement gaps, is required to assure methods are appropriate for their intended use ...[more]
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