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Business Potential for Agricultural Biotechnology - Asian Productivity ...

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<strong>Business</strong> <strong>Potential</strong> <strong>for</strong> <strong>Agricultural</strong> <strong>Biotechnology</strong> Products<br />

• Production of biological products usable in the food industry amounting to 15% of the<br />

need of the country.<br />

Benefiting from biotechnology is considered a way to decrease overuse of basic resources<br />

and contribute to their sustainability.<br />

Trends in Korean Animal <strong>Biotechnology</strong> and Production of Transgenic Livestock Harboring<br />

Recombinant Human Proteins in Milk and Urine<br />

The Republic of Korea has a large number of government institutes which undertake<br />

research on GMOs. Although the issue of GM food safety has not been settled, several GM<br />

crops are currently being imported as food ingredients as well as <strong>for</strong> industrial purposes. On the<br />

other hand, many researchers as well as biocompanies are in favor of GMOs that produce useful<br />

materials, since the organisms are accepted more easily by the general public when compared<br />

with GM food itself. The field of animal biotechnology has produced the most promising results<br />

in Korea, with special emphasis on the production of therapeutic proteins from transgenic<br />

animals, which is a highly cost-effective process. Although manufacture of pharmaceutical<br />

human proteins from transgenic animals is considered feasible using cost-effective bioreactor<br />

systems, only a few existing businesses seem successful in producing such animals. Only a<br />

single product has completed clinical trials and reached the market, after decades of research, but<br />

researchers and the pharmaceutical industry have continued pursuing the technology in the hope<br />

of achieving this goal within the next few years.<br />

There are two major targets <strong>for</strong> the production of <strong>for</strong>eign protein from the transgenic<br />

animal: milk and urine. In Korea, the National Livestock Research Institute (NLRI), Suwon, has<br />

been a leader in Korean livestock research since 1906. The Institute has a well-organized research<br />

system covering almost every aspect of farm animal research. Although the Animal <strong>Biotechnology</strong><br />

Division is relatively new, it has focused on current technologies, including the field<br />

of livestock cloning and transgenic animals. Using mouse whey acidic protein promoter as an<br />

expression controller, NLRI scientists designed a human erythropoietin (EPO) transgenic expression<br />

vector and introduced it into pig embryos via microinjection. The founder male was<br />

born in 1998. After the identification and analysis of hEPO proteins in its milk, NLRI has been<br />

producing TG progeny. NLRI researchers have also microinjected cloned transgene constructs<br />

into a one-celled embryo, which was then transferred to a surrogate sow. The resulting piglets<br />

were identified by PCR using genomic DNA from each piglet’s tail. In 1998, a transgenic<br />

founder was identified out of 47 candidate piglets using PCR and Southern blot analysis. The<br />

founder was later named “Saerome,” meaning “novel one” in Korean. Since 1999, a transgenic<br />

pig herd has been propagated. The milk from the transgenic female has about 880 units of<br />

human EPO in one milliliter of pig’s milk. After removal of glycosylation, this EPO showed the<br />

same molecular weight as commercial EPO that is identical to natural EPO without glycosylation.<br />

Amino acid sequence analysis showed that the EPO is indeed human EPO, not porcine<br />

EPO. Since Saerome, NLRI has produced a number of transgenic pig lines harboring human<br />

genes encoding therapeutic proteins such as human blood coagulation factor VIII or tissue plasminogen<br />

activator (t-PA) under regulatory control of mammary-gland-specific promoters (whey<br />

acidic protein or beta-casein promoter) or urinary-bladder-specific uroplakin II (UPII) promoter.<br />

NLRI has already shortened the timelines <strong>for</strong> the production of transgenic pigs.<br />

The Korea Research Institute of Bioscience and <strong>Biotechnology</strong> (KRIBB) announced that a<br />

transgenic cow, “Boram,” that can express human lactoferrin (hLF) in its milk, was generated<br />

utilizing microinjection. hLF is a pivotal protein, abundant in mother’s milk, that confers antibacterial<br />

functions on babies and elevates their immune responses. The complete gene encoding<br />

the hLF was isolated from a cosmid library and its structure was characterized. The expression<br />

level of hLF protein in a transgenic animal ranged from 0.1 to 34 g per ml.<br />

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