15 June, 2016

First AEMPS accreditation (Advanced Therapies)

FIRST ACCREDITATION FROM THE AEMPS FOR THE VIRAL PRODUCTION OF MEDICINES

The first accreditation from the Spanish Agency of Medicine and Sanitary Products (AEMPS) to Creatio Production and Validation Center of Advanced Therapies in the University of Barcelona: permission is granted to produce medicines though Advanced Therapies with the end goal of combating the AIDS virus. The first medicine that is being produced in the facility is a cellular vaccine against AIDS for a clinical trial which is to be led by the Hospital Clínic of Barcelona. The production of the cellular vaccine started in 2015, and it will extend until the beginning of 2018. The process will be carried out with the isolation and purification of the autologous virus and the isolation of dendritic cells from the patient, which will then be exposed to the virus having been isolated, expanded and inactivated. The objective being to cause a response from the patient’s immunological system against the virus, the goal being to remove the need for antiretroviral combination therapy, which inevitably the patient infected with AIDS will have to take for the rest of their lives. The development of this vaccine requires working in very specific high security facilities where the objective is to expand the virus in affected patients of AIDS (in a laboratory environment), an essential step to manufacture the vaccine. The facilities of Creatio – Production and Validation Center of Advanced Therapies, are the only facilities that are uniquely equipped for these procedures in Catalonia and are the only accredited facilities in Spain.