1.
Eur J Pharm Biopharm
; 198: 114151, 2024 May.
Article
in English
| MEDLINE
| ID: mdl-38043622
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.