Biopharmaceutical Analysis

Martin Samonig is manager of product management at Thermo Fisher Scientific.

Sylvia Grosse is application technician at Thermo Fisher Scientific.

Stephan Meding is product manager at Thermo Fisher Scientific.

Articles

Determining a peptide’s purity is challenging because impurities are often structurally similar to each other and the API and can be present at very low concentrations. New approaches offer a solution.

The Benefits of Combining UHPLC-UV and MS for Peptide Impurity Profiling

The company has built a fit-for-purpose liquid chromatography–mass spectrometry (LC–MS) system to streamline analytical monitoring tests for biopharmaceuticals.

Waters Launches SmartMS-Enabled LC–MS Biopharma System

Rita C. Peters is the former editorial director of 

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Complex Protein Studies Demand Dynamic Techniques

Pauline M. Rudd is a visiting investigator at Bioprocessing Technology Institute, Agency for Science, Technology and Research.

Xiaofeng Shi is development group leader at New England Biolabs.

Christopher H. Taron is scientific director, Protein Expression and Modification Division, at New England Biolabs.

Ian Walsh is an associate staff scientist at Bioprocessing Technology Institute, Agency for Science, Technology and Research.

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

Flush solutions for liquid chromatography mass spectrometry (LC-MS) systems and ultrapure solvents for ultra-high-performance LC-MS systems from Thermo Fisher Scientific can minimize interference and maximize lab instrument uptime.

Solutions and Solvents Improve Analytical Instrument Performance

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity. 

Expectations for Residual Impurity Analysis Continue to Rise

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Waters’ New UPLC Platform Meets Evolving Chromatography Needs

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Multiple Views Deliver Protein Particle Characterization

New, user-friendly analytical systems provide high-throughput comprehensive characterization and quantitation of small and large molecules.

Biopharmaceutical Analysis: HPLC/UHPLC