Bechtold-Peters, Karoline and Roesti, David (2024) Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products. European journal of pharmaceutics and biopharmaceutics, 198 (114151). ISSN 1873-3441; 0939-6411

Abstract

Holistic concepts should be applied that reduce risks prior to final bioburden testing and sterile filtration, based on enhanced process and product attribute understanding, which could be key to successful bioburden risk management. Key findings of this paper include.

Item Type:	Article
Keywords:	Filtration Biotechnology
Date Deposited:	18 May 2024 00:46
Last Modified:	18 May 2024 00:46
URI:	https://oak.novartis.com/id/eprint/52344