Les défis de stérilité et de contamination croisée dans le génie tissulaire et la médecine régénérative
La médecine régénérative est aujourd’hui en grande expansion. Avec des efforts de recherche croissants dans ce domaine, les aspects de fabrication commerciale pour les bioproduits attirent plus l’attention.
Du point de vue des BPF, le défi le plus critique en raison de facteurs spécifiques caractérisant la manipulation cellulaire est l’asepsie du processus.
Cet article met également en évidence d’autres facteurs critiques du processus pour présenter une vue complète des risques liés à cette activité.
Une solution possible à ces défis est la technologie d’isolement, couramment utilisée dans l’industrie pharmaceutique et suggérée par les directives réglementaires en la matière.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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Pharma
ATMP Thérapie génique et cellulaire
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