NMR based quality evaluation of mAb therapeutics: A proof of concept higher order structure biosimilarity assessment of trastuzumab biosimilars.
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DOI: 10.1016/j.jpba.2022.114710
Abstract: Higher-order structural (HOS) biosimilarity assessment is a regulatory requirement for intended biosimilars, and manufacturers are required to demonstrate the biosimilarity of their product in comparison to the reference product concerning both safety and efficacy. NMR… read more here.
Keywords: biosimilarity assessment; biosimilarity; order structure; assessment ... See more keywords