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Dev Biol (Basel). 2002;109:107-18. Related articles, Links
The use of an animal immunogenicity model in the development of Protropin somatrem (methionyl human growth hormone).
Jones AJ.
Department of Analytical Chemistry, Genentech Inc., South San Francisco, CA 94080, USA. aj@gene.com
The clinical development of methionyl human growth hormone, with particular emphasis on immunogenicity and the effects of antibody development, are summarized. In an animal model in rhesus monkeys, the immunogenicity of dinical preparations was reduced by the inclusion of additional purification steps in the manufacturing process. The immunogenic response in patients was also decreased by these improvements. No safety consequences related to antibody formation were observed and the occurrence of growth attenuation due to antibodies was found to be extremely low (<0.1%). The data suggest that the immunogenicity was not due to the N-terminal methionine or E. coli protein impurities: rather it was probably caused by small amounts of growth hormone with subtle structural alterations whose nature remains unknown.
Dev Biol (Basel). 2002;109:107-18. Related articles, Links
The use of an animal immunogenicity model in the development of Protropin somatrem (methionyl human growth hormone).
Jones AJ.
Department of Analytical Chemistry, Genentech Inc., South San Francisco, CA 94080, USA. aj@gene.com
The clinical development of methionyl human growth hormone, with particular emphasis on immunogenicity and the effects of antibody development, are summarized. In an animal model in rhesus monkeys, the immunogenicity of dinical preparations was reduced by the inclusion of additional purification steps in the manufacturing process. The immunogenic response in patients was also decreased by these improvements. No safety consequences related to antibody formation were observed and the occurrence of growth attenuation due to antibodies was found to be extremely low (<0.1%). The data suggest that the immunogenicity was not due to the N-terminal methionine or E. coli protein impurities: rather it was probably caused by small amounts of growth hormone with subtle structural alterations whose nature remains unknown.
