Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review

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作者
Rozaleen Dash
Sumit Kumar Singh
Narendra Chirmule
Anurag S. Rathore
机构
[1] Indian Institute of Technology Delhi,Department of Chemical Engineering, DBT Center of Excellence for Biopharmaceutical Technology
[2] IIT-BHU,School of Biochemical Engineering
[3] SymphonyTech Biologics,undefined
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cell-based assay; critical quality attributes (CQAs); functional comparability; ligand binding assay; mechanism of action (MOA);
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