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Asthma, allergic asthma and chronic idiopathic urticaria are almost invariably accompanied by elevated levels of IgE. Omalizumab is a recombinant DNA-derived humanized monoclonal antibody that selectively binds to human immunoglobulin (IgE). The antibody has a molecular weight of approximately 149 kDa. The liquid formulations of omalizumab are pharmacologically effective at high concentrated formulation, results in substantial increase in the protein-protein interaction and thereby increasing the viscosity of the formulation. The present study attempts to develop and optimize high concentration liquid formulation for omalizumab having high monomer, low aggregates, and desirable viscosity. The formulations were prepared by using different buffers, amino acids, and surfactants. All formulations were analysed for viscosity at fixed protein concentration. Based viscosity data, formulations were short listed and charged for stability at 37℃ up to one month. Stability samples at different time points were analysed for aggregation behaviour. Samples were also analysed for acidic and basic species. Based on data trend, the formulation was finalized and applied in the treatment of Asthma, allergic asthma and chronic idiopathic urticaria as subcutaneous administration.
Keywords:
Omalizumab, anti-IgE antibody, high concentration.
Cite Article:
"Development of high concentrated IgE antibody for anti-asthmatic therapy", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 6, page no.17 - 22, June-2023, Available :http://www.ijrti.org/papers/IJRTI2306004.pdf
Downloads:
000205171
ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator