By a News Reporter-Staff News Editor at Biotech Week -- Investigators publish new report on Hormones. According to news reporting originating in Boulder, Colorado, by NewsRx journalists, research stated, "Evaluation and mitigation of the risk of immunogenicity to protein aggregates and particles in therapeutic protein products remains a primary concern for drug developers and regulatory agencies. To investigate how the presence of protein particles and the route of administration influence the immunogenicity of a model therapeutic protein, we measured the immune response in mice to injections of formulations of recombinant murine growth hormone (rmGH) that contained controlled levels of protein particles."
The news reporters obtained a quote from the research from the University of Colorado, "Mice were injected twice over 6 weeks with rmGH formulations via the subcutaneous, intraperitoneal, or intravenous (i.v.) routes. In addition to soluble, monomeric rmGH, the samples prepared contained either nanoparticles of rmGH or both nano- and microparticles of rmGH. The appearance of anti-rmGH IgG1, IgG2a, IgG2b, IgG2c, and IgG3 titers following the second injection of both preparations implies that multiple mechanisms contributed to the immune response. No dependence of the immune response on particle size and distribution was observed. The immune response measured after the second injection was most pronounced when i.v. administration was used."
According to the news reporters, the research concluded: "Despite producing high anti-rmGH titers mice appeared to retain the ability to properly regulate and use endogenous growth hormone."
For more information on this research see: Recombinant Murine Growth Hormone Particles are More Immunogenic with Intravenous than Subcutaneous Administration. Journal of Pharmaceutical Sciences, 2014;103(1):128-139. Journal of Pharmaceutical Sciences can be contacted at: Wiley-Blackwell, 111 River St, Hoboken 07030-5774, NJ, USA. (Wiley-Blackwell - www.wiley.com/; Journal of Pharmaceutical Sciences - onlinelibrary.wiley.com/journal/10.1002/(ISSN)1520-6017)
Our news correspondents report that additional information may be obtained by contacting M. Christie, University of Colorado, Dept. of Chem & Biol Engn, Boulder, CO 80309, United States. Additional authors for this research include R.M. Torres, R.M. Kedl, T.W. Randolph and J.F. Carpenter (see also Hormones).
Keywords for this news article include: Boulder, Colorado, United States, Growth Hormones, Peptide Hormones, North and Central America, Anterior Pituitary Hormones
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