Mirikizumab API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Mirikizumab API

Mirikizumab is a recombinant humanized monoclonal antibody that selectively targets interleukin-23 (IL-23) by binding to the p19 subunit of IL-23. It is a biologic therapeutic used in the treatment of inflammatory diseases, particularly moderate-to-severe ulcerative colitis. Mirikizumab is marketed under the brand name Omvoh.

As a biologic active pharmaceutical ingredient, Mirikizumab is produced using recombinant biotechnology and requires specialized manufacturing, purification and analytical characterization. The molecule is an IgG4 monoclonal antibody designed to selectively inhibit IL-23-mediated inflammatory signaling.

Mirikizumab API is relevant to pharmaceutical biotechnology, biologics development, analytical research, formulation development and manufacturing of finished pharmaceutical products.

Product Overview

Mirikizumab is a humanized monoclonal antibody directed against the p19 subunit of IL-23. IL-23 is a cytokine involved in the regulation of inflammatory immune responses.

By selectively binding to IL-23 and preventing its interaction with the IL-23 receptor, Mirikizumab inhibits IL-23-mediated signaling. This mechanism helps reduce inflammatory activity associated with certain immune-mediated diseases.

Mirikizumab is an important biologic molecule for research and pharmaceutical development involving IL-23 pathway inhibition, inflammatory bowel disease and targeted immunomodulatory therapies.

Key Features of Mirikizumab API

  • Recombinant humanized monoclonal antibody
  • IgG4-based biologic
  • Selective IL-23 inhibitor
  • Targets the IL-23 p19 subunit
  • Biologic active pharmaceutical ingredient
  • Relevant to inflammatory disease research
  • Used in biologic pharmaceutical development
  • Suitable for analytical and formulation research
  • Requires specialized biologic manufacturing and quality control
  • Relevant to pharmaceutical biotechnology

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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