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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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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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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A CRO Leads the Way for Biotherapeutics Amid its Own ‘Field of Dreams’

By January 16, 2017

“If You Build it, He Will Come” 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… Read more >

Categories: Customer Stories, Pharmaceutical
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