Potential Inaccurate Quantitation and Sizing of Protein Aggregates by Size Exclusion Chromatography: Essential Need to Use Orthogonal Methods to Assure the Quality of Therapeutic Protein Products

JOURNAL OF PHARMACEUTICAL SCIENCES

卷 99, 期 5, 页码 2200-2208

ELSEVIER SCIENCE INC

biophysical models; protein aggregation; protein formulation; high-performance/pressure liquid chromatography (HPLC); analytical ultracentrifugation; analytical biochemistry; physical stability

Chemistry, Medicinal Chemistry, Multidisciplinary Pharmacology & Pharmacy