Live Biotherapeutic Products

Live Biotherapeutic Products (LBPs) are a novel class of therapeutic agents that utilize live microorganisms, such as bacteria or yeasts, to prevent, treat, or cure diseases in humans. They are distinct from probiotics, vaccines, gene therapy, and fecal microbiota transplants. LBPs exert their effects through mechanisms like modulating the gut microbiota, regulating immune responses, producing antimicrobial substances, and enhancing barrier functions in the body after engraftment [1][3][7].

The U.S. Food and Drug Administration (FDA) and the European Pharmacopeia define LBPs as biological medicinal products containing live organisms for therapeutic use. These products are subject to strict regulatory requirements due to their complexity and live nature. Current clinical applications include treating gastrointestinal disorders (e.g., inflammatory bowel disease), metabolic diseases (e.g., diabetes), and infectious diseases like recurrent Clostridioides difficile infections [3][5][7].

Read more in this overview article by Frontiers.

Sources:

[1] Live Biotherapeutic Products: Where Are We? - Frontiers https://www.frontiersin.org/research-topics/58633/live-biotherapeutic-products-where-are-we

[2] Biotherapeutika: Definition & Beispiele | StudySmarter https://www.studysmarter.de/schule/biologie/biowissenschaften/biotherapeutika/

[3] Live Biotherapeutic Products - Microbiological Expertise and Analysis https://www.vermicon.com/microbiome/live-biotherapeutics

[4] Lebende biotherapeutische Produkte - Mikrobiologische Expertise https://www.vermicon.com/de/mikrobiom/biotherapie

[5] Review Article: Safety of Live Biotherapeutic Products Used for the ... https://academic.oup.com/cid/article/77/Supplement_6/S487/7459152

[6] Forschung an Lebenden Therapeutischen Materialien geht weiter https://www.leibniz-inm.de/pressemitteilung/forschung-an-lebenden-therapeutischen-materialien-geht-weiter-saarland-bleibt-leuchtturm-in-der-biomedizin/

[7] Live Biotherapeutic Products, A Road Map for Safety Assessment https://pmc.ncbi.nlm.nih.gov/articles/PMC7319051/

[8] Was sind Biopharmazeutika? - Pharma+Food https://www.pharma-food.de/markt/was-sind-biopharmazeutika-151.html

[9] Live biotherapeutic products: the importance of a defined regulatory ... https://pubmed.ncbi.nlm.nih.gov/32908212/

[10] Live biotherapeutic products: the importance of a defined regulatory ... https://www.nature.com/articles/s12276-020-0437-6