BIOT 645 Insulin Detemir Discussion
Identify a protein of interest that your company will be manufacturing (e.g. a HER2 targeted antibody). The choice of protein is important, so please read ahead to understand the assignments in week 10 and week 12. In choosing a protein, please choose one that is already manufactured by another company in real life (though it will be “new” to your company), one for which there is published literature so you can find details on the production process and please do not choose one of the proteins that we have looked as so far in class.
Identify an appropriate model system and expression system in which your protein of interest will be expressed (e.g. CHO cells with double selection procedure)
Identify an appropriate biomanufacturing process for your protein using your model and expression system (e.g. Fig 3 in http://www.mdpi.com/2306-5354/1/4/188/htm)
Write a paper in prose (not outline) of up to five pages in length describing : The upstream and downstream processing steps involved in manufacturing the protein [including: what facilities / equipment are needed, what are the critical steps, how will the product be separated and purified?
The protein of Interest in “INSULIN detemir”
Insulin detemir, sold under the brand name Levemir among others, is a long-acting insulin used to treat both type 1 and type 2 diabetes. It is used by injection under the skin. It is effective for up to 24 hours.
Common side effects include low blood sugar, allergic reactions, pain at the site of injection, and weight gain. Use in pregnancy and breastfeeding appears safe. It works by increasing the amount of glucose that tissues take in and decreasing the amount of glucose made by the liver.
Insulin detemir was approved for medical use in the European Union in June 2004, and in the United States in June 2005. It is on the World Health Organization’s List of Essential Medicines. In 2019, it was the 121st most commonly prescribed medication in the United States, with more than 5 million prescriptions.
It is used to treat both type 1 and type 2 diabetes. A recent Cochrane systematic review also compared the effects of insulin detemir to NPH insulin and other insulin analogues (insulin glargine, insulin degludec) in both children and adults with Type 1 diabetes. With respect to blood sugar management, it appears to work better than NPH insulin, however this finding was inconsistent across included and previous studies. In the same systematic review no other clinically significant differences were found between different insulin analogues in either adults nor children.
Common side effects include low blood sugar, allergic reactions, pain at the site of injection, and weight gain. Use in pregnancy and breastfeeding appears safe.
It is an insulin analogue in which a fatty acid (myristic acid) is bound to the lysine amino acid at position B29. It is quickly absorbed after which it binds to albumin in the blood through its fatty acid at position B29. It then slowly dissociates from this complex.
Society and culture
On 13 June 2009, the U.S. Food and Drug Administration (FDA) issued a public health advisory for insulin determir after learning that 129,000 stolen vials reappeared and were being sold in the U.S. market. The FDA warned that the stolen vials “may not have been stored and handled properly and may be dangerous for patients to use.” The stolen vials were identified as lots XZF0036, XZF0037, and XZF0038.