Scott Berger

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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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An Inflection Point for Biopharmaceutical Host Cell Protein Analysis

By June 7, 2016

Has LC-MS Become a Generally Accepted Tool for Complementing Immunoassay-based HCP Analysis? My colleague Catalin Doneanu and I just returned from Lisbon, Portugal, where we attended the BEBPA Conference on Host Cell Protein (HCP) analysis.… Read more >

Categories: Pharmaceutical