November 10, 2015
Presenter: Dr. Linhardt
Department: Chemistry & Chemical Biology
Topic: Bioengineering and Metabolic Engineering of Heparin Drugs
Modern medicine would cease to exist without heparin. Heparin is an anticoagulant (prevents clotting), extensively used during surgery, transplants, and dialysis. The market for pharmaceutical heparin is approximately worth $7 billion (1 Bill Gates). It is obtained from pig intestines and the product is unregulated during its early stages, which has led to contamination of the drug (lives lost). Additionally, a majority of the production is controlled by China (hard to enforce regulations and could mean instability in supply). There is an essential need for an “alternative and more controlled source of heparin” because it would be nearly impossible to perform complex medical procedures that save lives without heparin.
Linhardt and his students are using biomolecular engineering and metabolic engineering to attempt to manufacture an alternative source of heparin. Heparin production would then be reliant on microorganisms which would produce the product by complex a complex metabolic process including the production of enzymes (biomolecular engineering). Heparin is a carbohydrate and therefore not made by ‘simply’ hijacking bacterial DNA in the manner that is used to produce proteins. The metabolic engineering project is attempting to manufacture heparin through fermentation in bacteria. The issue is that bacteria are not compartmentalized, and lack a Golgi body, thus making it difficult to organize the processes. Additionally, a problem with making an alternative source is scalability (increase production in 11 orders of magnitude) and intellectual property (patents). Once research approaches a certain stage it has to be performed at companies and not universities, because universities require publication and intellectual property protection requires secrecy.
Linhardt’s research for an alternative source of heparin is essential to medicine. Medicine affects many political and economical decisions. Heparin could lead to war if the supply became inadequate since it is currently an unstable supply chain. It can be only be produced at the large scale by pigs and the industry is controlled by China. Currently, foreign diplomacy is necessary to ensure the product’s supply. Conflicts with China could lead to a scarcity of the product. Also, an inefficient process is used to produce Heparin (one pig only gives 2 doses) and diseases (if many pigs were suddenly affected by a disease)) could endanger the product. Corruption and military takeover (rationing) could result if the quantity of the product becomes insufficient. The U.S. currently maintains strategic reserves of the product in case of contamination. The distribution of the drug would have to be prioritized in case of an emergency. It is also a $7 billion industry so foreign companies are always looking for ways to improve their profit. Adulteration has previously occurred, risking the purity and safety of the drug (effectiveness). If a new source for heparin was found, developing nations could also benefit from the drug and modern medicine practices since it may be available in larger quantities. Additionally, the U.S. would not have to rely on other countries.
Connections:
· Ms Moldoff- Government regulations apply in chemical and civil engineering.
· Clean room/ PN Junctions- It is difficult to manufacture bacteria that produce heparin, because bacteria are at the nanoscale and are alive. PN Junctions were difficult to produce because they had to be manufactured at the nanoscale.
· MILL- The goal is to make the U.S. self sufficient, and develop an effective and efficient manufacturing process (preferable assembly line process). It involves research and grant proposals to fund the cost ($2 million/ year). We are looking to manufacture in large quantities (economies of scale) to make it cheaper.
· Dr. Silva – chemical engineering process, and scalability issues/complexities
Terms Defined:
· Dialysis- It is used to purify blood (filter toxins) if kidney is not working properly.
· Adulteration- To make impure by adding foreign or inferior substance.
· Natural Product- It is a substance (chemical/ biological elements) derived or obtained from nature. Not all natural substances are good, e.g. radioactive Uranium isotopes and cyanide are both ‘natural’
· Synthetic Product- It is an artificial compound made through chemical reactions.
Sources
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