Subsidiary company launched: Biochrom Australia Pty Ltd.
Supplying our American and Asian customers directly: FBS from Australia
Biochrom AG supplies Fetal Bovine Serum (FBS) throughout Europe and the world. Biochrom AG has now established a sterile filtration system for FBS in Melbourne (Australia), so that in future the company can supply the Asian and American market directly, without having to take a detour via Europe. "Thus, with the proven quality of Biochrom AG, we are aiming to accommodate our customers in Asia and America", explains Dr. Bernd Frenzel, Director of the Biochrom Australia Pty Ltd branch.
In recent years the global demand for FBS has steadily increased. FBS is the most widely-used supplement in cell culture systems. It is a by-product of the meat industry and is obtained in regions with extensive cattle farming. It is also known as Fetal Calf Serum (FCS). The Biochrom AG FBS primarily comes from South America and Australia.
Biochrom AG imports Australian raw serum and processes it in Germany in accordance with the European Pharmacopoeia specifications. Now thanks to this new subsidiary branch, FBS can also be sterile-filtered directly in Australia and shipped. "At the same time new technology has been established in Australia: The entire process is carried out using disposables. Therefore cross-contaminations are even less likely to occur, and minimum cleaning is required", Dr. Frenzel explains the production conditions in Australia.
The Australian raw serum is delivered deep-frozen to Biochrom Australia Pty Ltd. in Melbourne. After being checked and approved, the FBS is defrosted under standardised conditions and pooled in a 1000-litre container, lined with a sterile single-use bag. By means of a multi-stage filter cascade (up to 0.1 µm), the serum is filtered into a sterile 1000-litre bag and from there filled into gamma-sterilised Biochrom flasks (Cleanroom, Class A). For industrial customers, lot sizes up to 2,000 l are feasible, as well as direct shipments to Asia and America.
Before release for sale, a wide range of chemical and physical parameters are analysed for quality control. The filtered serum is examined for sterility and any possible contamination with mycoplasmas. Additionally, the sera are tested to make sure that they are free of the Bovine Viral Diarrhoea Virus (BVD-MD), Bovine Herpes Virus-Type 1 (BHV-1) and Parainfluenza Virus Type 3 (PI3). The virus neutralisation test is used to test the sera for antibodies against these viruses. In addition, the cytopathogenicity, hemadsorption and immunoperoxidase staining tests must turn out negative before the serum is released. The sera are tested on different cell lines for customers.
