Abstract
For xenotransplantation, strategies to prevent transmission of microorganisms from the source animal to the human recipient must be closely coordinated since tissues and organs are classified as non-sterile. Strategies for international cooperation and coordination of xenogeneic infection / disease surveillance and response are available. The regulatory frameworks and criteria on microbial safety as published by World Health Organization (WHO), European Pharmacopoeia (Ph. Eur.), European Medicines Agency (EMA) as well as U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) and Center for Biologics Evaluation and Research (CBER), are outlined. Different sources of microbial germs are considered including potential infectious agents. Monitoring of livestock and testing of xenografts is accompanied by positive and negative controls to detect and to exclude tissue specific microorganisms such as bacteria. The criteria of microbial status to be considered for xenotransplants are summarized.
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