Recent posts

Enhancing Analytical Productivity by Breaking Down Silos (Part 2)

By October 30, 2018

For biopharmaceutical organizations working with contract labs, it’s important to consider how data and methods will be transferred and how generated data will be managed so that it meets data integrity and compliance requirements.

Categories: Pharmaceutical
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I Resolve to Get Better mAb Separations

By August 8, 2018

We listened and learned how scientists separate mAbs and ADCs; then we designed a novel column for LC-MS bioseparations A critical step toward the prolific and successful use of monoclonal antibodies (mAb) as biotherapeutics occurred… Read more >

Categories: Columns
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Enhancing Analytical Productivity by Breaking Down Silos (Part 1)

By July 20, 2018

Analytical methods transfer. Data integrity. A changing and more stringent regulatory landscape. All this, and more, impacts productivity in upstream and downstream biopharmaceutical processes. How is Waters looking to help address development challenges for biologics and biosimilars?

Categories: Pharmaceutical
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The Expanding Role of Mass Spec for Peptide Mapping in Multi-Attribute Monitoring Assays

By July 12, 2018

There are two primary multi-attribute monitoring (MAM) assay choices for biologic development and QC: subunit protein mass analysis and peptide mapping by LC-MS. Here we explore how peptide mapping LC-MS MAM workflows are being used.

Categories: Pharmaceutical
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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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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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A View of the Biopharmaceutical Industry in Asia — an Interview with Ken Fountain

By March 14, 2016

Ken Fountain, Director of Biopharmaceutical Business Development at Waters, recently returned from an insightful trip to Asia where he visited Waters customers in South Korea and attended the China Biopharma Executive Summit in Shanghai, in… Read more >

Categories: Pharmaceutical
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