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A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
Published on: September 22, 2011
Clinical use of biologicals produced in continuous cell lines
T Hoffman1, J Fratantoni, G Murano
1Center for Biologics Evaluation and Research, Bethesda, MD.
Abstract:
Recent advances in biotechnology, namely DNA cloning and hybridoma formation, have greatly increased the availability of biologicals for clinical use. cDNA directed proteins and monoclonal antibodies may now be produced in sufficient quantities for wide-ranging experimental uses and, in some cases, licensed applications. Furthermore, novel uses of biological substances produced in minute amounts for normal homeostasis may now be broached using "pharmacological" doses. Biologicals produced in continuous cell lines have found application in wide-ranging fields. These include: hormone replacement, vaccines, immunosuppression and immunotherapy, and control of homeostasis. Initial efforts have been focused in oncology and infectious disease, including HIV-infection. Currently, therapies for a wide variety of conditions including thrombo-hemorrhagic syndromes, inborn errors of metabolism, cataracts, and arthritis are being developed. Conceivably, virtually every aspect of medicine, including diagnosis and surgery, will be affected by this revolutionary approach.
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