Author Archives: Rajgopal Rudrarapu

Leveraging Prior Knowledge to Demonstrate Analytical Competency

Analytical groups are developing more methods than ever to address mounting demand for biopharmaceuticals. Still, such teams need to work within tight timelines to help candidate therapies advance quickly through clinical trials. During a May 2022 presentation, Rajgopal Rudrarapu (senior scientist at the Almac Group) pointed out that regulatory agencies allow biomanufacturers to apply prior knowledge to facilitate analytical development and validation. He described how his company leveraged prior knowledge to develop and validate a capillary isoelectric focusing (cIEF) method…