Case Study: Impact of CellPort Software on FDA Audits

This case study describes the use of the CellPort Cell Culture Suite Software-as-a-Service (SaaS) platform with in vitro testing for Biopharmaceutics Classification System (BCS) biowaiver approvals, where the US FDA permits human testing to be replaced by cell-based in vitro testing when determining bioequivalence of a generic drug to its non-generic counterpart.  The case study highlights the scope and power of the CellPort Cell Culture Suite, the world’s foremost software for managing all data, workflows, and activities for cell culture, cell banking, and cell manufacturing.   You can download a copy of the case study here.