Recent posts

‘If You Build it, He Will Come:’ A CRO Leads the Way for Biotherapeutics Amid its Own ‘Field of Dreams’

By January 16, 2017
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Urged on by a voice no one else could hear, Ray Kinsella, played by Kevin Costner in the movie Field of Dreams, cleared a few acres of corn to build a baseball field. Shortly after,… Read more >

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

By January 13, 2017
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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
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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
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Advancements in High-Resolution Analytics for the Characterization of Innovator and Biosimilar Therapeutics Part 1: Intact Proteins As the pharmaceutical industry continues to evolve its focus from small-molecule drugs to balanced product portfolios that include protein… Read more >

Categories: Pharmaceutical
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Is using Microflow LC in an Industrial Setting Really that Cumbersome?

By August 30, 2016

Microflow or nanoflow chromatography has been used mostly in the academic and fundamental research environment in the past for its various advantages over analytical liquid chromatography, but rarely in the industrial settings. This is most… Read more >

Categories: Pharmaceutical, Technologies
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What Bioanalysis Zone’s New Investigator Award Says About the Future of Science: An Interview with Erin Chambers, PhD

By August 15, 2016

Dr. Erin Chambers is a Director in the Scientific Operations group at Waters Corporation. She recently served as a judge for the Bioanalysis Zone New Investigator Award. I sat down with Erin to gauge her… Read more >

Categories: General, Pharmaceutical
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In Beverly, the Shoe Fits for Bioanalysis!

By July 20, 2016

This past May, many of the nation’s leading bioanalysts gathered in New England to share ideas and explore the latest advances in mass spectrometry, liquid chromatography, and sample preparation for large molecule quantification. At Waters’… Read more >

Categories: Pharmaceutical
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Oligonucleotide Therapeutics on the Rise… Again

By July 7, 2016

Oligonucleotide drug development has seen its share of ups and downs over the past 20 years – but why? The promise of antisense oligonucleotides (ASOs) and later small interfering oligonucleotides (siRNAs) as therapeutics that can… Read more >

Categories: Pharmaceutical
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Phenome Research Footprint Continues to Expand

By June 8, 2016
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Congratulations are in order as the University of Birmingham is the most recent university to expand the footprint of metabolic phenotyping research centres around the world. As state-of-the-art metabolic phenotyping facilities able to conduct small-scale… Read more >

Categories: Pharmaceutical

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

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