From the Results of Yesterday to the Biologic Drugs of Tomorrow

From the Results of Yesterday to the Biologic Drugs of Tomorrow

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.

Biosimilars Intensify the Need for Harmonized Data

Biosimilars Intensify the Need for Harmonized Data

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.

Biopharma Data: Chaos or Harmony?

Biopharma Data: Chaos or Harmony?

If data can throw your biotherapeutic development program into chaos, it can also help move you forward. Let’s see how.

T3 for polar compound retention

Infographic: What’s the Best Column for Polar Compound Retention?

Retaining and separating highly polar, water-soluble organic compounds has been a challenge for separations scientists who prefer reversed-phase chromatography as their technique of choice. See how Waters has addressed these analytical challenges with our T3 columns.

Oligo-mania! Interest in Oligonucleotides Continues to Rise

Oligo-mania! Interest in Oligonucleotides Continues to Rise

From oligonucleotides and peptides to messenger RNA and CRISPR, ’tides are enjoying their time in the sun A year ago we wrote how oligonucleotide therapeutic development, which had seen a huge wave of investment in the late 1990s and early 2000s followed by a precipitous decline in the late 2000s, was once again on the…

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

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

“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 to build a baseball field. Shortly after, magical things began to happen. When you first set eyes on the headquarters…

Analytical Tools for Developing Biosimilars: Part 3, Glycosylation, Aggregation, and Charge Variants

Analytical Tools for Developing Biosimilars: Part 3, Glycosylation, Aggregation, and Charge Variants

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.