Regulatory Perspective on Bioassay Implementation Strategies for Potency Evaluation of Biopharmaceuticals

Abstract

must be appropriately measured throughout the whole clinical development journey. The development strategy of a biological assay that is able to measure potency accurately and precisely needs to be based on both regulatory and business requirements. Regulatory expectations on potency tests are detailed in international guidelines and constitute a legal requirement for the registration of the drug in the region of submission. However, the development and implementation of biological assays are known to be expensive and time-consuming. This fact opens a debate on how to balance the companies’ business needs with the requests for Mode of Action (MoA)-mimicking cell-based assays to determine the potency of increasingly complex biopharmaceuticals. This article overviews the current regulatory requirements for the registration of new biological drugs in USA, Europe and Japan giving a focused perspective on bioassay development strategies.