A history of adventitious agent contamination and the current methods to detect and remove them from pharmaceutical products

William G Valiant; Kang Cai; Peter M Vallone

doi:10.1016/j.biologicals.2022.10.002

A history of adventitious agent contamination and the current methods to detect and remove them from pharmaceutical products

Biologicals. 2022 Oct:80:6-17. doi: 10.1016/j.biologicals.2022.10.002. Epub 2022 Nov 5.

Authors

William G Valiant¹, Kang Cai², Peter M Vallone³

Affiliations

¹ Biomolecular Measurement Division, Applied Genetics Group, National Institute of Standards and Technology, Gaithersburg, MD, USA.
² Biopharmaceutical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
³ Biomolecular Measurement Division, Applied Genetics Group, National Institute of Standards and Technology, Gaithersburg, MD, USA. Electronic address: peter.vallone@nist.gov.

PMID: 36347754
DOI: 10.1016/j.biologicals.2022.10.002

Abstract

Preventing adventitious agents from contaminating pharmaceutical products has been an important goal of regulatory agencies and industry for decades. Contamination of these products does not only erode consumer trust but also can have potentially serious health consequences. There are a wide variety of adventitious agents that can contaminate many different classifications of products, with each combination requiring different techniques for prevention or detection of adventitious agent contamination. This review seeks to give a brief overview of adventitious agents that have contaminated released pharmaceutical products, explain the different products that are at risk of contamination, then describe the methods commonly used for the prevention and detection of adventitious agent contamination.

Keywords: Adventitious agent; Adventitious virus; Contamination; Detection; Prevention.

Publication types

Review

MeSH terms

Biological Products*
Drug Contamination / prevention & control
Pharmaceutical Preparations
Viruses*

Substances

Biological Products
Pharmaceutical Preparations