PRODUCTION PROCESS OF FBS
Biosera FBS is derived from blood, collected 
asceptically using a closed sterile bag system. 
The blood is immediately centrifuged and the 
serum frozen for transfer to our processing 
facilities. On receipt at the processing plant, the
serum is thawed, tested for acceptability, pooled 
and passed through three 100nm (0.1um) filters. 
The serum is bottled in our class 10,000 
cleanroom in a class 10 hood.

FULL TRACEABILITY
For all batches we have full recorded traceability. Our labelling system is computerised and designed for batch-to-batch clarity and we monitor the movement of each batch through treatment and production to final packaging.

TESTING
Biosera vigorously tests serum for sterility, mycoplasma, specific viruses and the ability to 
support cell growth. Certified and special certified sera are subject to a battery of further tests 
including chemical components, protein electrophoresis and radial immunodiffusion. See 
example following of a certificate of analysis. 

STERILITY
All sera are tested for the absence of bacteria (under aerobic and anaerobic conditions) and 
fungi. The tests are carried out over 15 days.

MYCOPLASMA
Serum is tested for mycoplasma by inoculation of mycoplasma test broth followed by subculturing 
into 3T3 cell mono layers and mycoplasma test agar plates. The cells are incubated and stained 
and visually examined for the presence of mycoplasma.

VIRUSES
All of our serum is tested for Bovine Viral Diarrhoea (BVD), Infectious Bovine Rhinotracheitis (IBR), 
Parainfluenza Type 3 (PI3)

Sera are tested for the absence of the indicated viruses using cultures tha are grown for a minimum 
of 21 days in medium supplemented with 15% test serum. They are subcultured at least twice 
during this period. Positive control cultures that have been inoculated with viruses are tested in 
parallel. Test cultures must have a result of non-detection for cytopathic observations, fluorescent 
antibody staining, inclusion body staining and haemadsorption. The test is an Elisa test out of 
pooled batches of finalfiltered products.

ENDOTOXIN
Endotoxin testing standard against which the endotoxin levels are measured is standardised by 
USP reference endotoxin standard LAL method.

BSE
Raw material collected from cows over 30 months in the EU must be screened for BSE. The mother 
bovine are systematically tested by the veterinary service for the presence of prions in the brain 
which is the only part of the animal where prions are concentrated enough to be detected. Only 
batches shown to be free of BSE are then used.

CELL CULTURE 
Biological performance is assessed using cell culture medium supplemented with the serum 
being tested at a final concentration of 1%. During the test period, cultures are examined 
microscopically for any morphological abnormalities that may indicate toxic components in 
the serum. Cell growth, plating efficiency and cloning efficiency are tested on any of the 
following cell lines - HeLa, L929, SP2/O-AG8, MRC-5, CHO and BHK.