期刊论文Physicochemical and functional characterization of trastuzumab-dkst, a trastuzumab biosimilar复制

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P Goyal, J Iyer, L Adhikary, B Vats…
Future Medicinal …, 2021
Taylor & Francis
Aims: Preclinical comparative similarity studies of trastuzumab-dkst, a Herceptin® biosimilar, are reported. Materials & methods: Primary sequence and higher order structure and pharmacological mechanisms of action were compared using multiple techniques. Pharmacokinetics and repeat-dose toxicity were assessed in cynomolgus monkeys. Results: Primary structures were identical; secondary and tertiary structures were highly similar. Non-significant differences were observed for charge heterogeneity. Twelve of 13 glycan species …