FBS Biotech, US origin, fetal bovine serum, tested according EMEA 1793 and Ph. Eur. 2262, 0.2 µm sterile filtered

The bio-pharmaceutical industry is facing a constantly growing demand for high quality, extensively tested fetal bovine serum originating from FDA-approved regions. PAN-Biotech is meeting this demand and offers a new product, Fetal Bovine Serum Biotech, which is tested according to EMA (also known as EMEA) and Ph. Eur. guidelines. Fetal Bovine Serum Biotech originates exclusively from Australia or the USA, both of them are approved regions by FDA`s CFR. The entire production process is followed by close inspections and quality controls – from the collection of raw material to the final production and sterile filtration procedure, all steps are documented and traceable. Especially a possible contamination with bovine viruses has to be excluded. Therefore, a multitude of tests is performed to meet highest safety requirements.

This product is tested according to EMEA CPMP/BWP/1793/02 and Ph. Eur. 01/2008:2262 upon request. In addition, EMA/410/01 rev. 3 and EMA/CHMP/ BWP/457920/2012 rev. 1 are also included as guidelines for testing procedures. Besides extensive testing for viral contamination, supplementary sterility testing is performed before, during and after filling of the product.

Application

Fetal Bovine Serum Biotech is particularly suited for the production of virus, vaccine, monoclonal antibodies, recombinant protein and growth factors, as well as the manufacture of other bio-pharmaceutical products.