A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins
نویسندگان
چکیده
منابع مشابه
A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins
During manufacturing and storage process, therapeutic proteins are subject to various post-translational modifications (PTMs), such as isomerization, deamidation, oxidation, disulfide bond modifications and glycosylation. Certain PTMs may affect bioactivity, stability or pharmacokinetics and pharmacodynamics profile and are therefore classified as potential critical quality attributes (pCQAs). ...
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ژورنال
عنوان ژورنال: mAbs
سال: 2017
ISSN: 1942-0862,1942-0870
DOI: 10.1080/19420862.2017.1364326