SIOUX FALLS, S.D.--(BW HealthWire)--Aug. 12, 2002 Scientists today reported the successful application of proprietary cloning techniques to produce four calves that express a human chromosome fragment coding for the broad range of human antibodies. The research was the result of an ongoing joint effort between Hematech, LLC and Kirin Brewery Company, Ltd, to develop a system for the production of human polyclonal antibody-based therapeutics. The study design and results of this scientific achievement are published in today's advanced online edition of Nature Biotechnology, nature.com. Source: Hematech, LLC 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 the application is limited because human donors cannot be optimally immunized. "The development of a system for the production of unlimited quantities of human polyclonal antibodies against any disease agent represents a promising platform to help alleviate the current shortages of human immunoglobulin and to produce many novel therapeutics," commented James Robl, Ph.D., President and Chief Scientific Officer of Hematech. "In contrast to other human antibody production systems, a bovine system for the production of human polyclonal antibodies would be fast and easily scalable to tons of product. A cow carrying complete human antibody genes could simply be immunized against the target disease agent and human antibodies could be collected in a couple of months." "We believe, that the success of our collaboration with Hematech in producing transchromosomic calves carrying human antibody genes complements and extends our previous work in mice on human monoclonal antibodies, and opens up a vast new field of potential antibody therapeutic applications," said Isao Ishida, Ph.D., Leader of Antibody Development for Kirin's Human Antibody Section. About the Study Scientists from Kirin prepared a human chromosome fragment containing the un-rearranged sequences of two human genes that code for IgH and Ig-lambda, the two immunoglobulin proteins that make up the antibody molecule. The chromosome fragment was transferred from a hamster carrier cell line to a bovine cell line by a microcell fusion approach. 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 the advanced online edition of the September 2002 issue of the journal, Nature Biotechnology, Volume 20, DOI:10.1038/nbt727. The study was lead by James M. Robl of Hematech, LLC and Isao Ishida of the Pharmaceutical Division, Kirin Brewery Co., Ltd., in collaboration with scientists from Hematech, Kirin PD, 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 on mice and developed a novel human antibody-producing mouse named TC Mouse(TM), which carries the human heavy chain and kappa light chain immunoglobulin gene repertoire and is capable of producing a variety of fully human monoclonal antibodies. For more information on TC Mouse technology, visit the website at www.tcmouse.com. In addition, the pharmaceutical division is applying its knowledge of biotechnology to the development of advanced pharmaceutical products in the fields of nephrology, immunology and allergy-related diseases, oncology and blood cell production. 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. |