Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

Oct 21, 2016 by in BIOCHEMISTRY Comments Off on Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size

Fig. 9.1 Analytical characterization of IgG1 monoclonal antibody solutions containing soluble aggregates measured by orthogonal methods, SE-HPLC (a, b, c) and SV-AUC (d, e, f). Protein aggregates of varying size…

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Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties

Oct 21, 2016 by in BIOCHEMISTRY Comments Off on Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties

Instabilities 1. Physical • Conformational stability  Thermal denaturation  Cold denaturation  Pressure-induced denaturation  Chemical denaturation • Colloidal stability • Surface/interfacial-induced denaturation 2. Chemical • Deamidation • Asp isomerization • Fragmentation •…

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Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance

Oct 21, 2016 by in BIOCHEMISTRY Comments Off on Higher-Order Structure and Protein Aggregate Characterization of Protein Therapeutics: Perspectives from Good Manufacturing Practices and Regulatory Guidance

Alexander PA, He Y, Chen Y, Orban J, Bryan PN (2007) The design and characterization of two proteins with 88 % sequence identity but different structure and function. Proc Natl…

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