New generation immunoglobulins: in January production of clinical batches

Construction of the new production line for NGIG clinical batches, Kedrion’s new generation 10% immunoglobulins, has been completed at the Gödöllő plant, one of the Kedrion’s production plants, located near Budapest in Hungary. The first batch of NGIG for the feasibility test was produced in early September and the analytical results were compliant with specifications. At the beginning of 2015, these lots will be used for the IND (Investigational New Drug), the request for registration of new products for clinical trials that must be submitted in the USA. To this end, the Gödöllő production plant will be subject to a mock inspection carried out by Kedrion aimed at assessing compliance with the quality standards of the American health authorities (FDA).