Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars.
作者信息
Ghasriani Houman, Hodgson Derek J, Brinson Robert G, McEwen Ian, Buhse Lucinda F, Kozlowski Steven, Marino John P, Aubin Yves, Keire David A
机构信息
US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, Missouri, USA.
Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Ontario, Canada.
出版信息
Nat Biotechnol. 2016 Feb;34(2):139-41. doi: 10.1038/nbt.3474.
Abstract
摘要
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