Anurag S. Rathore | Authors
Articles
Intact Mass Analysis–Based Multi-Attribute Methods (iMAMs) for Characterization of Biopharmaceuticals
Some traditional MAM workflows are being substituted with iMAM workflows that rely on analyzing the intact mass of mAbs in their native form, resulting in significant improvements in high-throughput sample analysis.
Analytical Methods to Determine the Stability of Biopharmaceutical Products
A drug stability program is a fundamental part of ensuring product quality, safety, and efficacy. Here, we summarize essential guidelines, differences between large- and small-molecule stability, and the analytical methods used.
On Replication in Biopharmaceutical Analysis
What is the right number of replicates in biopharmaceutical analysis? Does the answer depend on the type of analysis?
Analytical Characterization of Host Cell Proteins (HCPs)
In response to regulatory concerns, host cell protein (HCP) analysis is now often conducted using LC–MS/MS. Unlike ELISA, LC–MS/MS can positively identify and quantify specific HCPs and characterize the total amount of HCPs present.
Establishing Analytical and Functional Comparability for Biosimilars
Recent assessments of four biosimilars illustrate how a combination of orthogonal, high-resolution tools is used to demonstrate analytical and functional biosimilarity.
Charge Detection Mass Spectrometry: What’s the “Big” Deal?
Charge detection mass spectrometry (CDMS) is a useful tool to characterize larger, more complex biopharmaceuticals like bispecific antibodies and ADCs.