Predictive In Vitro Vitreous and Serum Models and Methods to Assess Thiol-Related Quality Attributes in Protein Therapeutics

• Published in: Analytical chemistry (Washington) Vol. 92; no. 10; pp. 6869 - 6876
• Main Authors: Liu, Y. Diana, Chen, Yan, Tsui, George, Wei, Bingchuan, Yang, Feng, Yu, Christopher, Cornell, Christopher
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 19.05.2020
• Subjects: Analytical chemistry; Animals; Antibodies; Antibodies, Monoclonal - metabolism; biopharmaceuticals; blood serum; Chemistry; Computer simulation; Glutathione; Glutathione - metabolism; humans; Intravenous administration; intravenous injection; Models, Biological; oxidation; Oxidation-Reduction; Physiology; Product quality; Product safety; Proteins; Quality assessment; Quality management; Rabbits; Redox potential; Sulfhydryl Compounds - analysis; Sulfhydryl Compounds - metabolism; Thiols

In vitro models that mimic the in vivo environment can greatly facilitate and support criticality assessment of product quality attributes for therapeutic drugs to ensure product quality. An in vitro model is established to study and predict the impact of thiol-related attributes on safety or effica...