biotherapeutics 2 - Waters Blog

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

By Scott Berger January 13, 2017July 6, 2023 Reading Time: 8 minutes

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.

Analytical Tools for Developing Biosimilars: Part 2, Peptide Analysis

By Scott Berger January 13, 2017July 28, 2022 Reading Time: 5 minutes

Advancements in High-Resolution Analytics for Characterization of Innovator and Biosimilar Therapeutics Part 2: Peptide Analysis of Infliximab

How Analytical Technologies Support the Development of Biosimilar Drugs

By Scott Berger January 12, 2017July 6, 2023 Reading Time: 10 minutes

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 increasingly challenged to produce routine and automated characterization workflows that move innovator and biosimilar biopharmaceutical products forward through development and…

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

By Brian Murphy March 9, 2016July 6, 2023 Reading Time: 3 minutes

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?