Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products

Karoline Bechtold-Peters; Stephen Chang; Andrew C Lennard; Jeanne Mateffy; Marie Murphy; Melvyn Perry; David Roesti; Donald C Singer; Friedrich von Wintzingerode; Harry Yang

doi:10.1016/j.ejpb.2023.11.016

Risk-based approach to setting sterile filtration microbial bioburden limits - Focus on biotech-derived products

Eur J Pharm Biopharm. 2024 May:198:114151. doi: 10.1016/j.ejpb.2023.11.016. Epub 2023 Dec 1.

Authors

Affiliations

¹ Novartis Pharma AG, Basel, Switzerland. Electronic address: Peters@novartis.com.
² AstraZeneca, Gaithersburg, USA.
³ Amgen Limited, Uxbridge, UK.
⁴ Amgen, Thousand Oaks, USA.
⁵ Eli Lilly & Co., Kinsale, Ireland.
⁶ Pfizer Ireland Pharmaceuticals, Dublin, Ireland.
⁷ Novartis Pharma AG, Stein, Switzerland.
⁸ Ecolab Life Sciences, St. Paul, USA.
⁹ Genentech, Inc. A Member of the Roche Group, South San Francisco, USA.
¹⁰ Fate Therapeutics, San Diego, USA.

PMID: 38043622
DOI: 10.1016/j.ejpb.2023.11.016

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.

Keywords: Bacterial by-products; Bioburden limits; CFU; Case-by-case assessment of bioburden excursions (CCAB); Filter break-through; Microbial bioburden; Risk-based; Specification; Sterile filtration.

MeSH terms

Biotechnology*
Filtration*