Recent posts

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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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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Multi-Attribute Monitoring: The Expanding Role of Mass Spectrometry for mAb Subunit Analysis

By June 1, 2018

Two MAM approaches for biotherapeutic analysis are being implemented today; one focused on the analysis of monoclonal antibody (mAb) subunits, and the other focused on the analysis of peptides from a protein digest (peptide mapping workflow). Both have their advantages and disadvantages. Here, we explore MAM for mAb subunit analysis.

Categories: Pharmaceutical
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How to improve analytical method transfers for biotherapeutics

By May 21, 2018

“Assuming continuous improvement is a worthy goal, there is every reason to improve validated chromatographic methods if you’re working with the right instrument technology,” says Eric Grumbach of Waters. See what that means for developing and transferring methods for biologic drugs.

Categories: Pharmaceutical
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Setting a New Standard for Reserved-Phase Separations of Monoclonal Antibodies and Antibody Drug Conjugates

By May 15, 2018

A new approach to stationary phase chemistry for reversed-phase LC analysis of proteins, including monoclonal antibodies and antibody drug conjugates, delivers higher fidelity data especially for MS-based peak identification.

Categories: Columns
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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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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.

Categories: Pharmaceutical
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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.

Categories: Pharmaceutical
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