Kirin and Hematech, LLC report on the successful production of human antibodies in cloned calves creating a potential new source of human antibodies from cows.
Scientists reported on the successful application of proprietary cloning techniques to produce four calves that express a human chromosome fragment coding for a broad range of human antibodies. The research was the result of an ongoing joint effort between Hematech, LLC of Sioux Falls, South Dakota and Kirin Brewery Co., Ltd. of Japan to develop a system for the production of human polyclonal antibody-based therapeutics. The study design and results of this scientific achievement have been published in Nature Biotechnology http://www.nature.com/nbt/ .
These results are the first step in the development of a large-scale system for producing human polyclonal antibodies that could be used to prevent and/or treat a wide variety of diseases, including antibiotic resistant infections, autoimmune diseases, cancer and diseases resulting from bioterrorism. Currently, there is a substantial need for immunoglobulin, or broad-spectrum human polyclonal antibodies, for the treatment of many immune system disorders. However, the supply is limited to that which can be obtained from human donors and as such the application is limited because human donors cannot be optimally immunized.
The human antibody producing cloned calves (TC Cow™), represent a unique and efficient technology platform capable of producing unlimited quantities of human polyclonal antibodies against any disease agent that will help to alleviate current shortages in the human immunoglobulin supply. Being a bovine system, The TC Cow™ platform represents a fast and easily scalable production system for human polyclonal antibodies; once immunized with the target disease antigen, antibodies can be collected from the TC Cow™ within a matter of a few months.
About the Study
Scientists from Kirin prepared a human chromosome fragment containing the unrearranged sequences of two human immunoglobulin genes that code for the IgH and Igλ loci. The chromosome fragment was transferred from a hamster carrier cell line to a bovine cell line using microsome mediated chromosome transfer, or MMCT, a proprietary technology developed by Kirin scientists. Scientists at Hematech fused the bovine cells, containing the human chromosome fragment into cow eggs and transferred the resulting embryos into recipient cows to produce four cloned transchromosomic calves. The human chromosome fragment was retained in the calves and the human antibody genes carried on the chromosome fragment underwent normal processing. Human antibody proteins were detected in the blood of newborn calves.
The study was reported in a paper titled “Cloned Transchromosomic Calves Producing Human Immunoglobulin”, published in an advanced online edition of the September 2002 issue of the journal Nature Biotechnology. The study was led by Dr. James M. Robl of Hematech, LLC and Dr. Isao Ishida of the Pharmaceutical Division of Kirin Brewery Co., Ltd. in collaboration with scientists from Kirin, Hematech, Amherst College, Baylor College of Medicine, and the Department of Veterinary and Animal Science, University of Massachusetts, Amherst.
About Kirin Brewery Company, Ltd
Kirin Brewery's Pharmaceutical Division has developed a novel technology to introduce human chromosome fragments into animals. Kirin has applied this technology to mice and have developed a novel human antibody-producing mouse called the TC Mouse™, which carries the human heavy chain and kappa light chain immunoglobulin gene repertoire. The TC Mouse™ is capable of producing a variety of fully human monoclonal antibodies. For more information on the TC Mouse™ technology, please visit the website at www.TCMouse.com. In addition, the pharmaceutical division is applying its knowledge of biotechnology to the development of pharmaceutical products to treat renal disease, immune-related disease, allergy, oncology and hematology. Kirin's recombinant DNA-based ESPO (erythropoietin) and GRAN (G-CSF), co-developed with Amgen, have annual sales of about $400 million in Asia.
About Hematech, LLC
Hematech is a pioneer in the development and production of antibodies for therapeutic uses. Hematech's patented bovine transgenic technologies enable the company to rapidly produce unlimited quantities of uniform, high affinity, fully human antibodies for a wide variety of disease targets. Hematech intends to build a diversified portfolio of antibody products that the company will commercialize itself or through licensing arrangements with multiple pharmaceutical partners. For more information on Hematech, visit the company's website at www.hematech.com.
Click here to return to the news page.