Recent posts

From the Results of Yesterday to the Biologic Drugs of Tomorrow

By April 11, 2018

A thousand small delays and opportunities for error can snowball over the years of a complex biotherapeutic drug development program. They add up to lost time and increased risk in an endeavor that has little tolerance for either. It doesn’t have to be this way.

Categories: Pharmaceutical
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Biosimilars Intensify the Need for Harmonized Data

By February 28, 2018

To get the most out of recent innovations in biopharma development and QC such as multi-attribute monitoring, it’s time to better connect the systems that manage biopharma data. This series explores the what, the why, and the how of better biopharma data.

Categories: Pharmaceutical
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Biopharma Data: Chaos or Harmony?

By January 29, 2018

If data can throw your biotherapeutic development program into chaos, it can also help move you forward. Let’s see how.

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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.

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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

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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 >

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