About the Company
Eli Lilly and Company is an American drug firm whose head office is situated in Indianapolis, Indiana, U.S.A (Drugs.com, 2016). Other branches of the company are found in Puerto Rico and 17 other countries. The company sells its commodities to about 125 countries. Eli Lilly and Company were instituted in 1876 by Colonel Eli Lilly who served as a pharmacological chemist (Lilly, 2015a). Eli was a former participant of the American Civil War. The company was then named after him.
The company is renowned for the large-scale production of drugs such as penicillin, insulin, and Salk polio vaccines. Eli Lilly and Company pioneered in the manufacture of human insulin through the use of recombinant DNA technology. The company is also the biggest producer and supplier of psychiatric drugs worldwide. In 2009, the company was involved in a medical ethics scandal for selling one of its psychotic medications for purposes other than those endorsed by the US Food and Drug Administration. Consequently, the company was forced to pay half a billion US dollars as a penalty for the misdemeanor, which was among the largest criminal fines in history.
Nevertheless, the company was included among Fortune 500 corporations with a revenue of over $20 billion US dollars in 2008, ranking it the 148th largest company in the US and the 10th biggest conglomerate by international drug sales.
Biotechnology Method
The production of human insulin using recombinant DNA technology entails the use of Escherichia coli (E. coli) bacteria as cloning and expression vectors for DNA that codes for human insulin. An attenuated strain of E. coli, which is a resident flora of the human gastrointestinal tract, is used in this process. The genetic code for insulin exists in genomic DNA in the upper part of the short arm of chromosome 11 (Onengut-Gumuscu et al., 2015).
The size of the gene is 153 base pairs with 63 bases coding for the A chain of the protein and 90 bases responsible for the B chain. Initially, diabetic patients used insulin derived from pigs and cows. Despite the fact that insulin from cows and pigs resembled the insulin from humans, there were small variations that elicited immune responses such as the production of antibodies in some of the patients. The immune reactions countered the actions of the insulin and led to inflammation at the injection sites. Additionally, there were fears that the long-term production of animal-derived insulin was not sustainable (Brange, 2012).
These factors prompted investigators at Eli Lilly and Company to synthesize human insulin (Humulin) with the same chemical attributes as the natural protein using genetic engineering methods. Also, this method showed more promise regarding sustainability in the long run than the extraction and purification of the slaughterhouse byproduct.
The initial step towards this endeavor is to use a chemical process to synthesize the DNA that codes for the A and B chains of insulin in vitro. The synthetic synthesis of insulin DNA is possible because the amino acid sequences of the A and B chains have already been characterized and reported. An additional stop codon at the end of each chain is included to direct the termination of protein synthesis. Each chain has an anticodon that includes the amino acid methionine at the start. The role of the anticodon is to facilitate the extraction of insulin from E. coli cells’ amino acids.
A plasmid DNA is removed from an E. coli cell and cut up with restriction enzymes at specific sites. The plasmid is then incubated with synthetic pieces of DNA that code for the human insulin in the presence of the enzyme DNA ligase. The insulin DNA contains cohesive ends that are complementary to those generated in the plasmid by the restriction enzymes because the same restriction enzyme that is used to cut the plasmid is used to cut the DNA containing the insulin gene.
The artificial DNA sequences coding for the A and B chains are then interleaved independently into the B-galactosidase gene that is present in the vector’s plasmid. Therefore, there is a complementary base pairing between the sticky ends of the plasmid and those of the insulin DNA. DNA ligase acts as the molecular glue in recombinant DNA technology while restriction enzymes act as molecular scissors (Stewart, 2008).
The plasmid containing the insulin DNA, which is now referred to as a recombinant plasmid, is then inserted into E. coli cells. The cells are cultured under suitable conditions that allow for the replication of the original implanted DNA alongside the plasmid DNA, which induces the cell to express the gene leading to the production of insulin. Wild-type E. coli exudes biological catalysts that rapidly destroy extraneous proteins including insulin. To circumvent this problem, mutant strains devoid of these enzymes are used. B-galactosidase regulates the transcription of the insulin genes in E. coli hence the need to link the insulin gene to this enzyme (Ho, 2014).
The resultant protein comprises B-galactosidase linked to the A or B chain of insulin. These chains are removed from the B-galactosidase portion and refined. Thereafter, a chemical reaction links the two chains. Consequently, the biological activity of the proteins is instigated by the new protein configuration due to the availability of disulfide cross bridges. In this way, wholesome, artificial human insulin is produced through biotechnology.
Products or Services Provided by the Company
The firm produces, promotes, and disseminates more than 37 drugs in the US. These drugs are sold under different names in various countries. The company’s range of drugs includes medications in the fields of diabetes (insulin and glucagon injection), oncology, cardiovascular, critical care, immunology, and musculoskeletal complications. Products to cater to male-specific health are also available, for example, testosterone and tadalafil, which go by the brand names Axiron and Cialis respectively (Lilly, 2015b).
Eli Lilly and Company have a subdivision known as Elanco, which is dedicated to the manufacture of proteins, animal health products, and ensuring food safety. The substances produced by Elanco have been reported to be beneficial in food animal production and the wellbeing of livestock for more than six decades. These products contribute to the production of safe, wholesome, and reasonably priced food.
In addition, Elanco enriches animal wellbeing and helps pet owners to foster the human-pet bond. The Elanco Companion Animal Health division produces a wide variety of pet drugs, which play a significant role in prolonging pets’ lives. On the other hand, Elanco Food Solutions sells food-safety commodities and offers food-safety solutions to food animal trade.
Eli Lilly and Company also cares about its clientele by monitoring the benefits and risks of its drugs. The firm has a dedicated team of proficient regulators and healthcare providers who work towards this endeavor. Lilly maintains a pharmacovigilance system, which is tasked with gathering data throughout the life span of each product. This system is intended to uphold and appraise each item’s benefit/risk profile. The firm notifies physicians, patients, and regulatory bodies whenever any safety issues arise. The company’s patient safety organization employs more than 300 staff, including doctors, pharmacists, nurses, and other healthcare professionals.
References
Brange, J. (2012). Galenics of insulin: The physico-chemical and pharmaceutical aspects of insulin and insulin preparations. New York: Springer Science & Business Media.
Drugs.com (2016). Eli Lilly and Company: Company information. Web.
Ho, M. W. (2014). Evolution by natural genetic engineering. Science Society, 63, 18-23.
Lilly. (2015a). About Lilly. Web.
Lilly. (2015b). Our current products. Web.
Onengut-Gumuscu, S., Chen, W. M., Burren, O., Cooper, N. J., Quinlan, A. R., Mychaleckyj, J. C.,… & Achuthan, P. (2015). Fine mapping of type 1 diabetes susceptibility loci and evidence for colocalization of causal variants with lymphoid gene enhancers. Nature Genetics, 47(4), 381-386.
Stewart, N. (2008). Plant biotechnology and genetics: Principles, techniques and applications. Hoboken, NJ: John Wiley & Sons.