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Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
A history of adventitious agent contamination and the current methods to detect and remove them from pharmaceutical
William G Valiant1, Kang Cai2, Peter M Vallone1
1Biomolecular Measurement Division, Applied Genetics Group, National Institute of Standards and Technology, Gaithersburg, MD, USA.
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.
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