Glycosylation is an important post-translational modification that can impact the safety and efficacy of protein therapeutics and is therefore one of the most analyzed product attributes during development and quality control. In released N-glycan analysis, glycans are cleaved from proteins via enzymatic digestion and are chemically derivatized for relative quantification by liquid chromatography coupled… 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 >
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?
Multiple attribute monitoring has become a hot topic of discussion within biopharmaceutical organizations as the methodology allows detection and measurement of more critical quality attributes than conventional methods. Waters recently sponsored an outstanding webinar on… Read more >