A history of adventitious agent contamination and current methods for the detection and prevention of pharmaceutical product contamination.

Published

November 5, 2022

Author(s)

William Valiant, Kang Cai, Peter Vallone

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.

Citation

Biologics

Issue

80

Pub Type

Journals

Download Paper

https://doi.org/10.1016/j.biologicals.2022.10.002

Local Download

Keywords

virus, adventitious agent, pharmaceutical

Citation

Valiant, W. , Cai, K. and Vallone, P. (2022), A history of adventitious agent contamination and current methods for the detection and prevention of pharmaceutical product contamination., Biologics, [online], https://doi.org/10.1016/j.biologicals.2022.10.002, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=934732 (Accessed October 15, 2025)