Recent posts

Routine Mass Analysis Enables Greater Productivity in Biopharma Development

By January 15, 2019

Its great promise for routine monitoring of biologic drugs begs the question: Just when will LC-MS analysis become a true bedrock analytical tool for scientists and technicians throughout biopharma?

Categories: Pharmaceutical
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Enhancing Analytical Productivity by Breaking Down Silos – Part 3

By January 9, 2019

Analytical data can be so much more than a historical point in time documented in a single report. In fact, biopharmaceutical organizations can use LC-MS data to build a continuum of compliance.

Categories: Pharmaceutical
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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 >

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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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