The United States’ fourth case of mad cow disease (bovine spongiform encephalopathy) was discovered in Central California, the United States Department of Agriculture (USDA) reported Tuesday. The infected dairy cow was discovered at a rendering facility as part of routine testing for mad cow disease. While the meat was not intended for the food supply and USDA’s Chief Veterinarian, John Clifford stated “USDA remains confident in the health of the national herd and the safety of beef and dairy products,” it reminds us that the threat of contamination from adventitious agents is still present. The USDA has an ongoing surveillance program where 40,000 cattle are tested annually. The finding of 1 case in 40,000 implies that 850 cattle were likely positive for mad cow disease across the 34 million cattle slaughtered in the US in 2011. Today, not all cattle are tested prior to slaughter, so we don’t really know the actual number that were positive for mad cow disease, or any other prion-based disease for that matter. For this reason, there have been suggestions to test every animal prior to slaughter.
In biomanufacturing, where Fetal Bovine Serum (FBS) and other animal-derived ingredients are still used regularly, there is an ever-present risk of contamination from adventitious agents, such as viruses and prions including the infectious causative agents associated with Mad Cow Disease. In recent years, the use of animal derived cattle by-products have been restricted from use in feeding cattle. This is believed to reduce the incidence and spread of prions. However, this has not been implemented in biomanufacturing. Particularly affected are areas of biomanufacturing where animal products are still used regularly including vaccine production and stem cell manufacturing. Because alternatives exist to the use of FBS and other animal proteins, it is now possible to cost effectively remove of animal serum and blood derived products from biomanufacturing. And, because animal component and blood component free supplements are more consistent and well defined, it seems now is the time to move the industry away from animal and blood derived components. It would be foolish to wait and have this forced on the industry by government regulators.
Please see the following blogs for more information:
- In “Recombinant Protein Supplements Reduce the Threat of Adventitious Agents in Biomanufacturing,” we discuss the concerns associated with using animal derived ingredients and include ideas for efficient removal of animal products from culture.
- In “Quality vs. Cost in Biopharmaceutical Manufacturing – Ways to Achieve Both” we discuss the balance between reducing cost and maintaining the highest quality manufacturing practices, including removing animal ingredients from production.
- Lastly in “Exciting Treatment Possibilities with Stem Cells; What is the Best Culture Method?” we examine the promise of stem cells as a therapy and the pressing need to find a way to remove serum from stem cell culture before clinical manufacturing.