Deepika Sarin
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View article: Offline Coupling of Hydrophobic Interaction Chromatography–Capillary Zone Electrophoresis for Monitoring Charge‐Based Heterogeneity of Recombinant Monoclonal Antibodies
Offline Coupling of Hydrophobic Interaction Chromatography–Capillary Zone Electrophoresis for Monitoring Charge‐Based Heterogeneity of Recombinant Monoclonal Antibodies Open
A holistic understanding of the charge heterogeneity in monoclonal antibodies (mAbs) is paramount for ensuring acceptable product quality. Hence, biotherapeutic manufacturers are expected to thoroughly characterize their products via advan…
View article: Multi-attribute monitoring applications in biopharmaceutical analysis
Multi-attribute monitoring applications in biopharmaceutical analysis Open
Since the introduction of Quality by Design for production of biopharmaceuticals, the global biopharma industry has been advancing towards developing highly efficient and sensitive platforms for monitoring product quality attributes. Incor…
View article: Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability
Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability Open
The foundation of a biosimilar manufacturer's regulatory filing is the demonstration of analytical and functional similarity between the biosimilar product and the pertinent originator product. The excipients in the formulation may interfe…
View article: Monitoring oxidation in recombinant monoclonal antibodies at subunit level through two-dimensional liquid chromatography coupled with mass spectrometry
Monitoring oxidation in recombinant monoclonal antibodies at subunit level through two-dimensional liquid chromatography coupled with mass spectrometry Open
Monoclonal antibodies (mAbs) are highly susceptible to chemical/post-translational modifications (PTMs), a crucial concern for chemical and biological safety during mAb production and development. Modifications in different mAb domains hav…
View article: Two-Dimensional Liquid Chromatography (2D-LC): Analysis of Size-Based Heterogeneities in Monoclonal Antibody–Based Biotherapeutic Products
Two-Dimensional Liquid Chromatography (2D-LC): Analysis of Size-Based Heterogeneities in Monoclonal Antibody–Based Biotherapeutic Products Open
Monoclonal antibodies (mAbs) dominate the pipelines in the biopharmaceutical industry today. Being complex products, this class of molecules has numerous critical quality attributes (CQAs). Their thorough characterization is a necessary an…