Transboundary Animal Biologics, Inc. is a U.S. permittee for importation, distribution and sale of BIOAFTOGEN®, a quadrivalent vaccine for Foot and Mouth Disease (FMD). The permit states that the vaccine may only be administered as directed by USDA-APHIS-Veterinary Services as part of an official USDA animal disease control program. The importation, distribution and use of BIOAFTOGEN® will be managed by the USDA National Veterinary Stockpile.
BIOAFTOGEN® is the trade name of the Foot and Mouth Disease killed virus vaccine produced and distributed in Argentina by BIOGENESIS BAGO. The vaccine contains four FMD virus vaccine reference strains used in South America. BIOGENESIS BAGO is a leading animal health company in South America which develops, produces and markets a wide range of biological and pharmaceutical products for animal health.
BIOGENESIS BAGO supplies Foot and Mouth Disease vaccines to countries in South America where vaccination is practiced (Argentina, Bolivia, Brazil, Colombia, Ecuador, Paraguay, Peru and Uruguay). BIOGENESIS BAGO has had an important role with the provision of vaccines for Taiwan during the FMD emergency in 1997 and supplied vaccines to this market up to 2010.
BIOAFTOGEN® was first licensed in Argentina in 1952. Since then, it has been applied in the National FMD control program. In 1999, BIOGENESIS BAGO was contracted by SENASA (National Health and Agroalimentary Quality Service) to manage the Argentinean FMD Antigen and Vaccine Bank. This Bank provided the emergency vaccine used during the re-introduction of the disease in 2000. At the time of the outbreak, BIOGENESIS BAGO was able to rapidly scale up vaccine production and incorporate new field strains to meet the demand. The result was that the FMD outbreak was controlled in a very short period of time.
BIOAFTOGEN® has been administered twice a year to more than 95% of the cattle population in Argentina. More than 120 million doses were used each year. In 2006, BIOGENESIS BAGO began providing antigen concentrates to the North American Foot and Mouth Disease Vaccine Bank (NAFMDVB).
Capacity
Since 2000, approximately 1.5 billion doses of Biogenesis Bago FMD vaccine has been produced and used in South America and Taiwan. The company currently produces 200 million doses of multivalent FMD vaccines/year. The BIOGENESIS BAGO FMD vaccine plant is located in Garin, Buenos Aires Province, Argentina, about 50 km from the Ezeiza International Airport.
Manufacturing standards
BIOGENESIS BAGO has been certified under the GMP standard by SENASA Argentina, and the regulatory authorities of Colombia and Brazil. BIOGENESIS BAGO also has ISO 9001 Certification and has now been approved by the USDA Center for Veterinary Biologics as meeting 9CFR standards.
BIOAFTOGEN® is a killed virus vaccine. The viral antigens are chemically inactivated and kinetics of inactivation are monitored. Strict controls are applied to ensure complete viral inactivation. SENASA performs complete quality control of all the BIOAFTOGEN® batches in cattle to ensure safety and efficacy, previous to their release to the market.
Delivery of products
BIOGENESIS BAGO has an outstanding record for in time delivery of its products throughout Argentina, as well as of its exports to South America, Central Europe and Asia. BIOGENESIS BAGO assures that the appropriate temperature is maintained from the time the vaccine leaves the plant until arrival at destination. The International Division is trained to work with the import regulations of the destination country and to deliver the vaccine through a specialized transportation service.