FOETAL BOVINE SERUM 

Australian Origin

Bovogen Biologicals is a leading manufacturer and supplier of genuine Australian foetal bovine serum/fetal bovine serum (FBS) to the global life sciences community.

Australian origin Foetal Bovine Serum is highly sought after due to Australia’s freedom from all major epidemic diseases of livestock, including Foot and Mouth Disease, transmissible spongiform encephalopathies (TSEs) including bovine spongiform encephalopathy (BSE).

This status is collectively administered by The World Organisation for Animal Health (OIE), the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO), who are responsible for monitoring the international epidemiology of livestock diseases.

Bovogen Biologicals’ Foetal Bovine Serum is manufactured in our fully validated, purpose built sterile filtration facility, under strict GMP conditions, which ensures that it meets the highest quality standards. The closed loop system employed by Bovogen Biologicals is fully disposable so that no piece of equipment used in the manufacturing process comes into direct contact with product.

In further support of our quality manufacturing practices, Bovogen Biologicals is a recipient of a Certificate of Suitability from the European Directorate of Quality Medicines for its range of Australian origin foetal bovine serum (FBS) products. This certification meets the criteria described in the current version of the monograph “Products with Risk of Transmitting Agents of Animal Spongiform Encephalopathies No. 1483 of the European Pharmacopoeia. This Certificate of Suitability certifies Bovogen Biologicals’ foetal bovine serum for use in the manufacture of medicines within the European Union.

The vast majority of the analytical testing performed on Bovogen Biological’ FBS is performed by suitably qualified and certified external laboratories. This provides an element of independence in relation to finished product test results which are reported on Certificates of Analyses.

General Description: Bovogen Biologicals’ sterile FBS is manufactured in a closed loop system to provide a final product with low endotoxin and haemoglobin levels. The process is closely monitored from blood collection to sterile filtration (3 x 0.1µm) in a fully validated and dedicated state-of-the-art filtration facility to ensure the highest level of quality is maintained.

Raw Material Origin: All foetal bovine serum is collected from Australian registered export abattoirs under the supervision of Government Veterinary authorities. In line with our quality systems, the origin of Bovogen FBS is fully traceable back to the abattoir and is supported by the availability of full collection and manufacturing records, leaving no doubt as to its’ source.

Appearance: Clear, orange/brown solution, free of any particulate matter.

Applications: Applications include:

Certificate of Suitability: Bovogen Biologicals Australian Origin FBS has a Certificate of Suitability (RO CEP 2007-361-Rev 00) from the European Directorate of Quality Medicines (EDQM).

Documentation: A Certificate of Analysis is supplied with all FBS orders. A Certificate of Origin is also supplied for export orders.

Storage and Handling: Product is shipped and stored at -10 to -40°C.

Ordering Information:

Manufacturing to specification/additional processing subject to negotiation.