Little, laureen, Borer, Matt, Bulik, Dorota, Deming, Stanley, Estdale, Sian, Foltz, Seth, Kolen, Zeban, Merges, Mike, Rigsby, Peter, Robinson, Jane, Sadick, Mike, Sondag, Perceval and Gottar-Guillier, Marie (2024) Reference Standards for Potency Assays. BEBPA website.

Abstract

This paper presents an overview of current practices common in the biopharmaceutical industry for the development of in-house reference standards for use in bioassays to determine the potency of biopharmaceutical preparations. It does not necessarily represent the views of every contributor nor of the organizations to which they are affiliated. It is intended to highlight some of the most common issues encountered in the development of reference standards and the ways in which some organizations address these. It should not be interpreted as an instruction to adopt a particular procedure or methodology. Relevant current regulatory guidelines should always be consulted and discussion with regulatory authorities undertaken when necessary.

Item Type:	Article
Keywords:	Potency Assay, Reference Standards
Date Deposited:	02 Oct 2024 00:45
Last Modified:	02 Oct 2024 00:45
URI:	https://oak.novartis.com/id/eprint/53713