Live biotherapeutic products: the importance of a defined regulatory framework

Abstract

Prevention and treatment: When living microbes become medicines Regulatory frameworks must be stretched to include microbe-based medicines such as “live biotherapeutic products” (LBPs). Some LBPs are similar by nature to probiotics, health-enhancing living microbes, except that they are meant to treat or prevent disease in sick or vulnerable individuals. Bruno Pot at the Vrije Universiteit Brussel in Belgium and co-workers have reviewed how current food and drug regulations in the United States and the European Union apply to living microorganisms. As for all drugs, in the case of LBPs, quality, safety, and efficacy must be demonstrated, but LBPs pose extra challenges because they contain live organisms, raising issues of stability over time and batch-to-batch variation. Differences in patients’ microbiomes and diets add further complications. This review helps to outline a way forward in this new and developing field of medicinal products.