Streamlined Multi-Attribute Assessment of an Array of Clinical-Stage Antibodies: Relationship Between Degradation and Stability

• Published in: Applied spectroscopy Vol. 79; no. 1; pp. 87 - 103
• Main Authors: Pastrana, Belinda, Culyba, Elizabeth, Nieves, Sherly, Sazinsky, Stephen L., Canto, Eduardo I., Noda, Isao
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.01.2025
• Subjects: asparagine and glutamine deamidation; 2T2D; two-dimensional correlation spectroscopy; quantum cascade laser microspectroscopy; 2D-COS; two-trace two-dimensional; protein stability; cation exchange; Biotherapeutic; extent of deamidation; protein aggregation; high-performance liquid chromatography; correlation spectroscopy; co-distribution correlation spectroscopy; HPLC

Clinical antibodies are an important class of drugs for the treatment of both chronic and acute diseases. Their manufacturability is subject to evaluation to ensure product quality and efficacy. One critical quality attribute is deamidation, a non-enzymatic process that is observed to occur during t...