Dr. Mireia López Siles and her team at the Universitat de Girona, Spain, are spearheading the development of KlebsiGene, a prophylactic DNA vaccine designed to prevent infections caused by Klebsiella pneumoniae. This bacterium, notorious for its antibiotic resistance, poses a significant threat in both healthcare and community settings.
To facilitate KlebsiGene’s market entrance, the team sought to establish a comprehensive regulatory roadmap during the proof-of-concept phase. Given the scarcity of similar products, especially in Europe, navigating the regulatory landscape was challenging. The team leveraged the ISIDORe EATRIS Regulatory advice service to define the regulatory scope, interpret relevant monographs, and ensure compliance with European regulatory requirements.
ISIDORe’s services were instrumental in identifying key regulatory points related to efficacy, safety, and quality. The team conducted an initial meeting with an expert, reviewed provided documents, and utilized ongoing assistance to align their development process with regulatory standards. This included overseeing safety procedures, assessing materials and facilities, and establishing necessary safety tests.
As a result, the regulatory framework for KlebsiGene has been clarified. The team is now developing a list of approved materials and protocols, and reviewing laboratory conditions to ensure good practices during vaccine development. By the project’s end, they aim to have a comprehensive list of regulatory documents required for patent licensing.
ISIDORe’s support has been pivotal in advancing KlebsiGene closer to clinical trials and market entry. This flexible technology also holds potential for similar products targeting other applications, showcasing the broader impact of ISIDORe’s services in pandemic preparedness and response.