Recent posts

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
Tags: , , , , , ,

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, Technologies
Tags: , , , , , , , , , , ,

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
Tags: , , , , , , , , , ,

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
Tags: , , , , , , , ,

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
Tags: , , , , ,

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
Tags: , , ,

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
Tags: , , , , , , , , , ,

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
Tags: , , , , , ,

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
Tags: , , , , , , , , , ,

Three Reasons for Biopharmaceutical Labs to Add Mass Detection to Routine Analyses

By March 9, 2016

As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?

Categories: Pharmaceutical, Technologies
Tags: , , , , , , , , , , , , , , , , , , , ,