Search results for " mass spectrometry"
Article
Methods Accelerate Biosimilar Analysis
Focus is placed mainly on high-resolution mass spectrometry (HR-MS) for primary structural analysis and characterization of post-translational modifications and various biophysical techniques for high…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Figure 1: The total ion current (TIC) chromatogram obtained from on-line reverse phase-high-performance liquid chromatography with electrospray mass spectrometry (RP-HPLC/ES-MS) analysis of a monoclon…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The chromatographic eluent is then analyzed by mass spectrometry (MS) to identify the masses of individual structures. This is a useful technique because the chromatographic profile not only gives a b…
Article
Impurity Testing of Biologic Drug Products
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Physicochemical characterization:
• Liquid chromatography–tandem mass spectrometry (LC–MS/MS) following digestion for primary amino-acid sequencing, which could be complete…
Article
Analysis of Glycosylation in Biosimilars
This leaves released, derivatized carbohydrates, which is advantageous in each of the three mass spectrometry-based analytical techniques used to determine the glycosylation pattern.
In matrix-ass…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
…omatography (HPLC or UHPLC, respectively) coupled to fluorescence detection (FLR), often with inline mass spectrometry (MS). Typically, dextran ladder mobility (GU values) and mass data (m/z) are col…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Another way to measure the presence of aggregation is mass spectrometry. “Under the right conditions, mass spectrometry is particularly useful for structural characterization of intact protein aggrega…
Article
Managing Residual Impurities During Downstream Processing
…e traditional wet chemistry techniques for heavy-metal determination with inductively coupled plasma mass spectrometry (ICP-MS) in a risk-based approach for monitoring levels of potential elemental i…
Article
Biosimilar Quality Requirements
Effective Analytical Methods
High-resolution mass spectrometry (HR–MS) is the go-to method for primary structural analysis and characterization of complex protein molecules, particularly following…
Article
Elucidating Biosimilars Characterization
Glycans are traditionally analyzed using either liquid-phase separation techniques such as liquid chromatography or capillary electrophoresis with optical or fluorescence detection or mass spectrometr…