On August 20 and 28, 2009, personnel were sent from the Department of Health to inspect the two suppliers that provide embryonated chickens’ eggs used by Adimmune Corporation to manufacture pandemic influenza A (H1N1) vaccine.
After inspection, the suppliers were found to be closed-house chicken farms equipped with automated feeding system and the suppliers were found to regularly monitor the environment of the farms and the health of the chickens.The processes of egg collection and hatching of eggs both follow appropriate disinfection procedures.The embryonated chickens’ eggs are all produced by healthy and age-appropriate chickens, conforming to the requirements of the World Health Organization (WHO).

According to the WHO requirements, the embryonated chickens’ eggs used in influenza vaccine seed virus subculture should be specific pathogen-free (SPF).In addition, the eggs must come from healthy and age-appropriate chickens.

Since embryonated chickens’ eggs are considered as an important material in manufacturing influenza vaccine, pharmaceutical companies should evaluate their suppliers according to Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice (PIC/S GMP) regulations to ensure the quality of the manufacturing materials.It has been confirmed that Adimmune Corporation has inspected its suppliers of embryonated chickens’ eggs.Simultaneously, Adimmune Corporation has requested the suppliers to tests the embryonated chickens’ eggs they provide.The embyronated chickens’ eggs must not be tested positive for Salmonella enteritidis, Salmonella gallinarum and Salmonella Typhimurium, and the eggs must not be infected with avian influenza virus, avian leukosis and Newcastle disease virus (NDV).Further, no hormone and antibiotic residues such as β-lactam and chloramphenicols should be found in the embryonated chickens’ eggs. The feed must not contain animal materials.The transport temperature must maintain at 28~34℃.