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 >