Recent posts

From Characterization to Late Development, Manufacturing, and QC: The Expanding Role of Mass Spectrometry in Biotherapeutics

By January 26, 2018

The improvements in LC-MS technology under GxP compliant-ready informatics for biopharmaceutical analysis has prepared the industry to expand the role of MS technologies beyond product characterization toward monitoring product and process quality attributes.

Categories: Pharmaceutical
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Analytical Tools for Developing Biosimilars: Part 3, Glycosylation, Aggregation, and Charge Variants

By January 13, 2017

In biotherapeutics, the state of glycosylation has a direct and pronounced effect of the structure, stability, serum half-life, immunogeneicity and bioactivity of the molecule, and constitutes a critical quality attribute (CQA). In our study, characterizing and comparing the glycosylation profile of infliximab began by examining the glycosylation profiles from intact and reduced subunit mass data.

Categories: Pharmaceutical
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Analytical Tools for Developing Biosimilars: Part 2, Peptide Analysis

By January 13, 2017

Advancements in High-Resolution Analytics for Characterization of Innovator and Biosimilar Therapeutics Part 2: Peptide Analysis of Infliximab

Categories: Pharmaceutical
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How Analytical Technologies Support the Development of Biosimilar Drugs

By January 12, 2017

Advancements in High-Resolution Analytics for the Characterization of Innovator and Biosimilar Therapeutics As the pharmaceutical industry continues to evolve its focus from small-molecule drugs to balanced product portfolios that include protein therapeutics, analytical chemists are… Read more >

Categories: Pharmaceutical
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Three Reasons for Biopharmaceutical Labs to Add Mass Detection to Routine Analyses

By March 9, 2016

As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?

Categories: Pharmaceutical, Technologies
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