Inaktivierung von Pathogenen durch niederenergetische Elektronenstrahlung
Eine Plattformtechnologie für Keimreduktion und Impfstoffproduktion
Originale
Key WordsNiederenergetische Elektronenbestrahlung | LEEI | Keimreduktion | Totimpfstoffe | Elektronenstrahlung | Plattform-Technologie
Abstract
Pathogen Inactivation by Low Energy Electron Radiation – A platform technology for germ reduction and vaccine production
Pandemics triggered by microbial and viral pathogens remain a major challenge for global vaccine production. Irradiation with low-energy electrons (LEEI) can safely and reliably inactivate a large number of microbial pathogens, regardless of whether they are pathogens that are pathogenic to humans or relevant to veterinary medicine. The commercial LEEI platform, with its high precision controlled doses, enables more flexibility and, at the same time, a high level of robustness. Optimized for pharmaceutical processes, the LEEI platform can be used as an orthogonal tool for germ reduction (viral clearance) in existing value chains and in the vaccine industry in particular. In addition, radiation approaches in cell therapy are conceivable. The LEEI platform can be flexibly integrated within a given process infrastructure and enables batch or continuous process management. This platform is designed for operation with pathogens of biosafety level 2–3 and maps the necessary biocontainment, radiation protection and a GMP-compliant production environment inside. Critical process parameters can also be monitored inline using appropriate sensors.
Korrespondenz:
Daniel
