Bovine Spongiform Encephalopathy (BSE, “Mad Cow Disease”) has been very much in the spotlight in the past. Because humans are susceptible to BSE, one of the questions asked is: “What precautions are in place to prevent the transmission of this disease via medicinal products that have been manufactured using bovine serum?”
Guidance on this applies to a wide range of ruminant-derived materials and focusses on risk minimization. In order to establish compliance, companies must submit detailed information covering all aspects of sourcing, collection and processing for expert review.
There is no evidence that BSE has ever been transmitted via a medicinal product and experts have documented that no infectivity has been found in the blood of afflicted cattle.
Although BSE is a relatively new disease, similar diseases called transmissible spongiform encephalopathies (TSEs) have been known for a long time in both animals and humans.
The exact nature of the agents that cause these TSEs is still under investigation, but they are very resistant to many of the chemical and physical treatments that efficiently destroy bacteria, viruses, and other microorganisms.
It is not possible to effectively “treat” a material like bovine serum to inactivate the BSE agent, so precautions must be taken to ensure that the material is free from the BSE agent at the outset and that it is manipulated in such a way as to avoid its introduction.
The OIE monitors the incidence of BSE in the world and publishes this information on a regular basis. Regulatory authorities and processors use it as one of the critical determinants in deciding which countries may be used as a source of serum.
BSE is a disease of older animals. This gives rise to an additional safeguard. Source animals for bovine serum must be less than three years old – a cut-off that is based upon scientific input and consensus