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HUMAN GROWTH HORMONE BIOASSAY

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					                                      HUMAN GROWTH HORMONE BIOASSAY

              This is a cell line which can be used to assay human growth hormone. Currently
              manufacturers of human growth hormone use an animal model for quality control
              which costs several million dollars per year. For a fraction of that cost, this cell line
              offers: simpler ease of use, and greater sensitivity and specificity.


              Market Need and Opportunity
              Manufacturers of human growth hormone (hGH) currently use a hypophysectomised rat model
              (removal of pituitary gland) to assay the potency and efficacy of hGH in their quality control
              procedures. This model is expensive and extremely labour intensive. Furthermore ethical and public
              relations considerations dictate that pharmaceutical companies should, wherever possible, phase out
              animal testing. The use of this cell line would provide obvious benefits in terms of cost, ease of use
              and specificity to the manufacturers.

              The total global human growth hormone market currently stands at over US$2.2 billion dollars and the
              leading manufacturers of recombinant hGH include Novartis (Sandostatin LAR), Pfizer (Genotropin),
              Eli Lilly (Humatrope), Novo Nordisk (Norditropin), Genentech (Nutropin), Serono (Saizen, Serostim)
              and Ipsen (Somatuline) among others.


              IMBcom’s Position

              Technology
              The technology relates to a human growth hormone receptor (hGHR) expressing cell line (mouse
              proB) developed by Professor Waters at the University of Queensland’s Institute for Molecular
              Bioscience. The cell line has been independently shown, by Lucky Goldstar Life Science (LGLS)s, to
              provide much greater sensitivity and specificity than the hypophysectomized rat assay currently used.
              The LGLS studies also showed that the hGHR cell line was superior in terms of specificity and
              selectivity to a cell line they (LGLS) had developed in house.

              Intellectual Property
              In collaboration with Alpharma Pty Limited a validation report has been produced which includes
              standard operating procedures and performance characteristics, all of which were developed under
              good laboratory practice frameworks.




IMBcom Pty Ltd (the commercialisation company for the institute for molecular bioscience)

Level 4 Queensland Bioscience Precinct                                       PO Box 6415                Telephone +61 7 3346 2180
306 Carmody Road, The University of Queensland                               St Lucia Queensland 4067    Facsimile +61 7 3346 2181
Brisbane Queensland 4072, Australia                                          Australia                         www.imbcom.com.au

				
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Description: HUMAN GROWTH HORMONE BIOASSAY