Greater than 98.0% as determined by:
(a) Analysis by RP-HPLC.
(b) Analysis by SDS-PAGE.
The development of rBST began in the 1970s when scientists discovered and patented the gene responsible for producing bovine somatotropin . Using recombinant DNA technology, researchers were able to insert this gene into bacteria, enabling the bacteria to produce the hormone. This process allowed for the large-scale production of rBST, which could then be administered to dairy cows to enhance milk production .
Several pharmaceutical companies, including Monsanto, American Cyanamid, Eli Lilly, and Upjohn, developed commercial rBST products and sought approval from the US Food and Drug Administration (FDA) . Monsanto was the first company to receive FDA approval and marketed their product under the brand name "Posilac" . In 2008, Monsanto sold its rBST business to Eli Lilly and Company .
rBST works by increasing the levels of another hormone called insulin-like growth factor 1 (IGF-1) in cows. IGF-1 is essential for cell growth and replication, and its increased levels stimulate milk production in dairy cows . The synthetic hormone is typically administered through injections, leading to a significant boost in milk yield.
The use of rBST has been a subject of controversy due to concerns about its impact on animal welfare and human health. Studies have shown that cows treated with rBST are more prone to udder infections (mastitis), which often require antibiotic treatment . This increased use of antibiotics has raised concerns about the potential development of antibiotic-resistant bacteria .
In terms of human health, there have been debates about whether consuming milk from rBST-treated cows could increase the risk of cancer due to elevated levels of IGF-1 in the milk . However, the FDA, World Health Organization, and National Institutes of Health have stated that dairy products from rBST-treated cows are safe for human consumption .
Due to the controversies surrounding rBST, its use has been banned in several countries, including the European Union, Canada, Japan, Australia, New Zealand, and Argentina . In the United States, the FDA approved rBST in 1993, but products containing milk from rBST-treated cows must include a disclaimer stating that no significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows .