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Trends in Korean Animal <strong>Biotechnology</strong><br />

Transgenic Goats<br />

Production of Human Granulocyte Colony-Stimulating Factor using Goat b-casein Promoter<br />

(Meddy) (Source of in<strong>for</strong>mation: 12 May 1999. Korea Herald Newspaper; 2003 Hanmi Company<br />

report. Patents WO0015808, US6635474)<br />

The pharmaceutical company Hanmi has produced the transgenic goat “Meddy” (inh<br />

collaboration with KAIST, KRIBB, and ChungNam National University) which produced<br />

human granulocyte colony-stimulating factor (hG-CSF), one of the hematopoietic factors that<br />

control the differentiation of pluripotent stem cells into many kinds of blood cells during hematopoiesis<br />

(Ko et al., 2000). It also plays a key role in the stimulation of proliferation and differentiation<br />

<strong>for</strong> other types of blood cells, in addition to granulocytes and macrophages. This is a<br />

promising drug <strong>for</strong> many kinds of disorders related to reduction of neutrophil and other blood<br />

cell levels. If the materials derived from the goat’s milk are effective, the price of G-CSF will be<br />

decreased. Humans produce on the average only small amounts of G-CSF, which has made the<br />

protein extremely expensive <strong>for</strong> white-cell-deficient cancer patients. The cost of producing G-<br />

CSF from genetically altered animals is one-tenth of the cost of obtaining it from mammalian<br />

cells, the method commonly used in advanced countries. The hG-CSF gene was subcloned into<br />

plasmid pGbc behind the 1.7 kb sequence of the goat b-casein promoter and named pGbc-hG-<br />

CSF. The expression cassette of pGbc-hG-CSF was microinjected into fertilized mouse eggs and<br />

goat eggs. One mouse and two transgenic goats named Meddy and Serry were identified by PCR<br />

analysis and Southern blotting. According to Hanmi, the company has established a method of<br />

purifying G-CSF from the milk of transgenic goats and has produced the fourth generation of<br />

Meddy, confirming the stable transfer of the G-CSF gene. Currently, one gram of G-CSF costs<br />

about KRW 900 million, and the global market <strong>for</strong> the protein is estimated at USD1.4 billion<br />

each year, according to KAIST. The Korean market <strong>for</strong> the protein is estimated at KRW 15<br />

billion. Each injection of G-CSF (400 micrograms) costs around KRW 260,000. Hanmi is<br />

currently working on large-scale breeding of the transgenic goat and is planning clinical trials<br />

with purified G-CSF in 2005.<br />

CONCLUSION<br />

Transgenic animal research has received firm support from the Korean government since<br />

the late 1990s and will be given a major stimulus in 2005 with the launching of the national<br />

grants program. Although the technology has yet to produce a final product, there have been<br />

several successfully created transgenic farm animals. It is expected that the first successful<br />

product that can undergo clinical trials will be produced within the next few years.<br />

REFERENCES<br />

Datamonitor. Therapeutic Proteins: Strategic Market Analysis and Forecast to 2010. 2002.<br />

Dimond P.F. Transgenic technology in the production of therapeutic proteins. Innovations in<br />

Pharmaceutical Technology 1996; 92–97.<br />

Egrie J.C., Browne J.K. Development and characterization of novel erythropoiesis stimulating<br />

protein (NESP). Nephrology Dialysis Transplantation 2001; 16: 3–13.<br />

Fisher J.W. Erythropoietin: physiology and pharmacology update. Experimental Biology and<br />

Medicine 2003; 228: 1–14.<br />

Greer J.W., Milam R.A., Eggers P.W. Trends in use, cost, and outcomes of human recombinant<br />

erythropoietin, 1989–98. Health Care Finanial Revue 1999; 20(3): 55–62.<br />

GTC company press release 2004. http://www.gtc-bio.com/pressreleases/pr022704.html. 2004.<br />

Hammer R.E., Pursel V.G., Rexroad C.E. Jr., Wall R.J., Bolt D.J., Ebert K.M., Palmiter R.D.,<br />

Brinster R.L. Production of transgenic rabbits, sheep and pigs by microinjection. Nature<br />

1985; 315(6021): 680–683.<br />

Houdebine L.M. Transgenic animal bioreactors. Transgenic Research 2000; 9: 305–320.

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