Immunogenicity of aggregates of recombinant human growth hormone in mouse models

Aggregation of recombinant therapeutic protein products is a concern due to their potential to induce immune responses. We examined the immunogenicity of protein aggregates in commercial formulations of recombinant human growth hormone produced by freeze-thawing or agitation, two stresses commonly e...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2009-09, Vol.98 (9), p.3247-3264
Hauptverfasser:	Fradkin, Amber Haynes, Carpenter, John F., Randolph, Theodore W.
Format:	Artikel
Sprache:	eng
Schlagworte:	Agitation Animal models Animals Antibody Formation Biological and medical sciences Chemical Precipitation Female Freeze Drying Freeze-thawing General pharmacology Growth hormone Human Growth Hormone - immunology Human Growth Hormone - therapeutic use Humans Immune response Immunogenicity immunology Medical sciences Mice Mice, Inbred C57BL Particle Size Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Pregnancy Pressure protein protein aggregation Protein Conformation protein folding/refolding protein formulation Recombinant Proteins - immunology Recombinant Proteins - therapeutic use Solubility Stress structure transgenics
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