Live Biotherapeutic Products, A Road Map for Safety Assessment.

Autor:	Rouanet A; Pharmabiotic Research Institute - PRI, Narbonne, France., Bolca S; MRM Health NV, Zwijnaarde, Belgium., Bru A; Lallemand SAS, Blagnac, France., Claes I; YUN Probiotherapy, Niel, Belgium., Cvejic H; Accelsiors CRO, Budapest, Hungary.; Department of Pharmacy, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia., Girgis H; Biose®, Arpajon-sur-Cère, France., Harper A; Medical Affairs Department, ADM Protexin Ltd., Somerset, United Kingdom., Lavergne SN; Biofortis Mérieux NutriSciences, Saint Herblain, France., Mathys S; PharmaBiome AG, Zurich, Switzerland., Pane M; Probiotical Research Srl, Novara, Italy., Pot B; Science Department, Yakult Europe BV, Almere, Netherlands.; Research Group of Industrial Microbiology and Food Biotechnology, Vrije Universiteit Brussel, Brussels, Belgium., Shortt C; Johnson & Johnson Consumer Services EAME Ltd., Foundation Park, Maidenhead, United Kingdom., Alkema W; NIZO Food Research B.V., Ede, Netherlands., Bezulowsky C; IPSEN Pharma, Boulogne-Billancourt, France., Blanquet-Diot S; University Clermont Auvergne, UMR 454 MEDIS UCA-INRA, Clermont-Ferrand, France., Chassard C; University Clermont Auvergne, INRAE, VetAgro Sup, UMRF, Aurillac, France., Claus SP; LNC Therapeutics, Bordeaux Cedex, France., Hadida B; Exeliom Biosciences, Dijon, France., Hemmingsen C; Chr. Hansen A/S, Hørsholm, Denmark., Jeune C; Biose®, Arpajon-sur-Cère, France., Lindman B; Metabogen, Mölndal, Sweden., Midzi G; Medical Affairs Department, ADM Protexin Ltd., Somerset, United Kingdom., Mogna L; Probiotical Research Srl, Novara, Italy., Movitz C; Metabogen, Mölndal, Sweden., Nasir N; Astel Medica, Tinlot, Belgium., Oberreither M; Lactosan, Kapfenberg, Austria., Seegers JFML; Caelus Health, Zegveld, Netherlands., Sterkman L; Caelus Health, Zegveld, Netherlands., Valo A; Pilèje, Paris, France., Vieville F; 5QBD-Biotech, Aydat, France., Cordaillat-Simmons M; Pharmabiotic Research Institute - PRI, Narbonne, France.
Jazyk:	angličtina
Zdroj:	Frontiers in medicine [Front Med (Lausanne)] 2020 Jun 19; Vol. 7, pp. 237. Date of Electronic Publication: 2020 Jun 19 (Print Publication: 2020).
DOI:	10.3389/fmed.2020.00237
Abstrakt:	Recent developments in the understanding of the relationship between the microbiota and its host have provided evidence regarding the therapeutic potential of selected microorganisms to prevent or treat disease. According to Directive 2001/83/EC, in the European Union (EU), any product intended to prevent or treat disease is defined as a medicinal product and requires a marketing authorization by competent authorities prior to commercialization. Even if the pharmaceutical regulatory framework is harmonized at the EU level, obtaining marketing authorisations for medicinal products remains very challenging for Live Biotherapeutic Products (LBPs). Compared to other medicinal products currently on the market, safety assessment of LBPs represents a real challenge because of their specific characteristics and mode of action. Indeed, LBPs are not intended to reach the systemic circulation targeting distant organs, tissues, or receptors, but rather exert their effect through direct interactions with the complex native microbiota and/or the modulation of complex host-microbiota relation, indirectly leading to distant biological effects within the host. Hence, developers must rely on a thorough risk analysis, and pharmaceutical guidelines for other biological products should be taken into account in order to design relevant non-clinical and clinical development programmes. Here we aim at providing a roadmap for a risk analysis that takes into account the specificities of LBPs. We describe the different risks associated with these products and their interactions with the patient. Then, from that risk assessment, we propose solutions to design non-clinical programmes and First in Human (FIH) early clinical trials appropriate to assess LBP safety. (Copyright © 2020 Rouanet, Bolca, Bru, Claes, Cvejic, Girgis, Harper, Lavergne, Mathys, Pane, Pot, Shortt, Alkema, Bezulowsky, Blanquet-Diot, Chassard, Claus, Hadida, Hemmingsen, Jeune, Lindman, Midzi, Mogna, Movitz, Nasir, Oberreither, Seegers, Sterkman, Valo, Vieville and Cordaillat-Simmons.)
Databáze:	MEDLINE
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