Fetal bovine blood is collected using equipment designed to prevent microbial contamination, and carefully monitored procedures.
The process takes place in a separate specially constructed area in the slaughterhouse/abattoir under clean, controlled conditions.
To view Flowcharts outlining every step of the manufacturing process, click here
The aseptically collected fetal blood is refrigerated immediately and allowed to clot. It is then centrifuged to separate the serum from the blood clot. The serum is kept frozen in carefully identified clean, hygienic containers until it is thawed immediately prior to further processing.
A pre-defined quantity of serum is processed and tested to form what is called a “batch” or “lot” of finished product. Processing of each batch is performed under controlled conditions by
Thawing the designated material in a controlled environment and pooling it
“Sterile Filtration” passing the material through a series of membrane filters with tiny pores of reducing size, the last of which will have a pore size that is small enough to remove and retain bacteria and fungi
The batch is frozen again immediately after filtration to preserve its quality.
Samples are carefully tested using approved tests to confirm freedom from bacteria and other microorganisms. Extensive biochemical and biological testing are also performed. To view Testing details, click here
Viruses are not removed by sterile filtration. Therefore, the batch must be tested to ensure that it is free from contaminating viruses. The method of choice for viral removal is gamma irradiation. To view articles on gamma irradition, click here
Records are kept ensuring that each process step and the results of all testing can be linked directly to each individual batch of serum
The customer may also perform tests on the batch prior to purchase. This usually includes checks to confirm that the batch will perform optimally with the customer’s specific cell lines of interest.
The overall testing process is very labor intensive and may take several months to complete.