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.
Advancements in High-Resolution Analytics for Characterization of Innovator and Biosimilar Therapeutics Part 2: Peptide Analysis of Infliximab
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 >
Oligonucleotide drug development has seen its share of ups and downs over the past 20 years – but why? The promise of antisense oligonucleotides (ASOs) and later small interfering oligonucleotides (siRNAs) as therapeutics that can… Read more >
There is a rightfully high expectation from consumers that the amounts of compounds and ingredients that producers report in their goods are accurate down to trace levels. Whether personally or professionally, we all rely on… Read more >
We’re all familiar with the adage, “Out with the old, in with the new,” but we probably tend to think of it as it applies to clothes for donation or past relationships, and maybe not… Read more >
The quality issues of biopharmaceutical therapeutics are definitely different from chemical drugs because of the increased complexity of manufacturing processes and complexity of the biologic molecules themselves. There is an increasing need for detailed product… Read more >
Ken Fountain, Director of Biopharmaceutical Business Development at Waters, recently returned from an insightful trip to Asia where he visited Waters customers in South Korea and attended the China Biopharma Executive Summit in Shanghai, in… Read more >
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?
ProteinWorks and GlycoWorks kits address more than sample prep challenges One of the most challenging parts of an LC-MS workflow happens before analytical chemists even turn to their instrument: Sample preparation. Get it right, and… Read more >