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High Performance Size Exclusion Chromatography and High-Throughput Dynamic Light Scattering as Orthogonal Methods to Screen for Aggregation and Stability of Monoclonal Antibody Drug Products
Ashwinkumar Bhirde, Bhaskara Vijaya Chikkaveeraiah, Ramesh Venna, Rachel Carley, Kurt Brorson, Cyrus Agarabi
United States Food and Drug Administration Center for Drug Evaluation and Research
来源Journal of Pharmaceutical Sciences
年份2020
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学术脉络
学科主题
生物医学Protein purification and stability
Monoclonal and Polyclonal Antibodies Research · Analytical Chemistry and Chromatography
参考文献 35
Experimental Detection and Characterization of Protein Aggregates
被引 31Vikas Sharma, Devendra S. Kalonia · 2010
A REVIEW SIZE-EXCLUSION CHROMATOGRAPHY FOR THE ANALYSIS OF PROTEIN BIOTHERAPEUTICS AND THEIR AGGREGATES
被引 549Paula Hong, Stephan M. Koza, Edouard S. P. Bouvier · Journal of Liquid Chromatography & Related Technologies · 2012
Role of analytical ultracentrifugation in assessing the aggregation of protein biopharmaceuticals
被引 136Steven A. Berkowitz · The AAPS Journal · 2006
此处列出前 3 条
引用本文 18
Size exclusion chromatography of biopharmaceutical products: From current practices for proteins to emerging trends for viral vectors, nucleic acids and lipid nanoparticles
被引 73Valentina D’Atri, Mateusz Imiołek, Colette F. Quinn · Journal of Chromatography A · 2024
Navigating the Expansive Landscapes of Soft Materials: A User Guide for High-Throughput Workflows
被引 27Erin C. Day, Supraja S. Chittari, Matthew P. Bogen · ACS Polymers Au · 2023
Rapid Estimation of Size-Based Heterogeneity in Monoclonal Antibodies by Machine Learning-Enhanced Dynamic Light Scattering
被引 18Anuj Shrivastava, Shyamapada Mandal, Sudip K. Pattanayek · Analytical Chemistry · 2023
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