As any immunologist knows, antibodies are a critical reagent used by many researchers on a daily basis, from scientists in academia and industry to hospitals and diagnostic labs. A wide range of experimental and clinical diagnostic techniques, including western blots, immunohistochemistry, ELISAs and flow cytometry, require the use of antibodies. Moreover, antibodies are commonly used as treatments for various forms of cancer or autoimmune disease.
Since antibodies are crucial across many fields of biomedical research, naturally, demand for them is very high. Many major biotech companies provide antibodies in large quantities to researchers, and prominent amongst them is Santa Cruz Biotechnology (SCBT). SCBT is one of the largest antibody suppliers on the market, owning half the market share of the $1.6 billion antibody industry (according to a survey done in 2012 by The Scientist). Yet earlier this year, it was forced to shut down its antibody production and to pay an unprecedented fine of $3.5 million by the United States Department of Agriculture (USDA).
The process of deriving antigen-specific antibodies is almost identical to the vaccination process. Simply put, it involves injecting an antigen (any biological substance that would trigger an antibody response) into the bloodstream of an animal, with goats, rabbits or mice being the most common. The presence of this antigen triggers an antigen-specific humoral response in the animal, which allows for the extraction of antibodies from their serum. Producing antibodies on a large scale requires the raising, caring and sacrificing of many animals; as such, these processes are subjected to tight regulations to ensure ethical treatment of the animals involved.
In the case of SCBT, however, reports from various sources alleged that animal abuse had been occurring for years. Complaints against SCBT had been filed with the USDA as early as 2007 regarding violations of the Animal Welfares Act (AWA). Since then, investigations by the USDA have uncovered 3 separate reports of animal mistreatment. Most notably, an unaccounted animal facility owned by SCBT containing 814 goats, 12 of which were found to be in poor conditions including untreated coyote bites and tumours, was found in 2013 (although the company denied its existence). Furthermore, just last year, over 2000 rabbits and 3000 goats disappeared from their antibody production facility. While SCBT ultimately reached the aforementioned settlement for these numerous violations, after years of legal battles between the USDA, no charges were brought against any personnel.
While ethics committees and veterinarians are present at research facilities to ensure the well-being and ethical treatment of animals, the practices of antibody suppliers have a much greater impact on animal well-being given the scale on which they operate. This incident with SCBT has caught the attention of researchers in all fields, and may be a key step in making antibody suppliers more accountable to the broader research community. Policy makers around the world have the moral and social obligation to better enforce animal use regulations to ensure that commercial enterprises – such as antibody suppliers – are giving animals the best possible treatment. Additionally, the industry must be able to police itself to avoid mistreatment of animals and increase transparency regarding their practices. Ultimately, everyone involved in the commercial research enterprise is responsible for ensuring that ethical standards of animal care are upheld while still providing us with fundamental tools for research and healthcare.
- Antibody producer settles USDA case, relinquishes AWA credentials. American Physiological Society 2016.
- Bird, C. Antibodies user survey. The Scientist. May 1, 2012.
- Ferguson, C. Valuable antibodies at a high cost. The New Yorker. February 12, 2014.
- Lowe, D. Trouble at Santa Cruz Biotechnology. In the Pipeline [Science Translational Medicine]. May 23, 2016.
- Reardon, S. Thousands of goats and rabbits vanish from major biotech lab. Nature News. February 19, 2016. doi:10.1038/nature.2016.19411
- Reardon, S. US government issues historic $3.5-million fine over animal welfare. Nature News. May 20, 2016. doi:10.1038/nature.2016.19958
- Shen, H. Discovery of goat facility adds to antibody provider’s woes. Nature News. January 14, 2013. doi:10.1038/nature.2013.12203