This overview of the key precautions taken to significantly reduce possible risks is driven by the use of FBS in pharmaceutical/vaccine manufacture
The conditions and methods of slaughter, collection, storage, manipulation, processing, treatment, testing, and transport are all very carefully controlled to minimize the risk of the serum contamination with living microorganisms or undesirable non-living material.
Bovine blood is only collected in countries that have a known, well-monitored, documented and acceptable animal health status. ISIA member companies and regulatory authorities make use of the information published by the World Organization for Animal Health (the “WOAH”) in deciding which countries are acceptable. The WOAH (an intergovernmental organization) is responsible for establishing and publishing the animal health status of countries/regions.
The diseases monitored by WOAH include many diseases that are transmitted from animal to animal (e.g., foot and mouth disease) and also potentially zoonotic diseases (i.e., transmissible from animals to human).
Source countries must also have in place an infrastructure that includes authority-licensed slaughterhouses/abattoirs, acceptable to national and international bodies and dedicated to the processing of healthy animals. The animals must be inspected by qualified authority-recognized experts before slaughter, and meat from the animals must be passed as fit for human consumption.
ISIA member companies have Quality Assurance systems for the monitoring and evaluation of equipment, facilities, and training of staff.
As an additional safeguard fetal bovine and donor serum is often gamma irradiated using controlled procedures in facilities specially validated for this purpose. To learn more about Gamma irradiation, click here.
All the above is comprehensively documented to ensure that procedures can be seen to have been followed, and that relevant test results are available for every step and for every batch of processed serum that is produced.
The “traceability” of all the material that makes up each batch of serum from collection to product is recognized by ISIA member companies as being imperative; it provides the necessary assurances that a specified batch of serum cannot have been substituted with another of unknown quality (and thus unknown safety). The ISIA has therefore established a very comprehensive traceability policy. Click here.
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