Omalizumab is a recombinant humanized monoclonal antibody and an important biological pharmaceutical API used in the development and manufacture of medicines targeting IgE-mediated allergic and inflammatory conditions. Unlike conventional small-molecule active pharmaceutical ingredients, Omalizumab is a complex biological molecule produced using recombinant biotechnology. FDA describes Omalizumab as a recombinant DNA-derived humanized IgG1κ monoclonal antibody with an approximate molecular weight of 149 kilodaltons. It is produced using a Chinese hamster ovary (CHO) cell suspension culture.
The API is identified by CAS Number 242138-07-4 and UNII 2P471X1Z11. Omalizumab is also associated with identifiers including IGE25, RG-3648, rhuMab-E25 and the anti-IgE monoclonal antibody E25.
Omalizumab is not a conventional low-molecular-weight chemical substance. It is a large, structurally complex antibody consisting of protein chains with defined higher-order structure, disulfide bonds and glycosylation characteristics. Consequently, a conventional molecular formula is not normally the most useful way to describe the pharmaceutical substance.
For CMS purposes, molecular weight approximately 149 kDa is a more meaningful identifier than a conventional small-molecule molecular formula. FDA documentation specifically reports an approximate molecular weight of 149 kDa.
Omalizumab belongs to the IgG1κ monoclonal antibody class. Its biological target is human immunoglobulin E (IgE). By binding IgE, Omalizumab reduces the amount of free IgE available to interact with the high-affinity FcεRI receptor on mast cells, basophils and other relevant immune cells.
Omalizumab is an established therapeutic monoclonal antibody used in several IgE-associated inflammatory and allergic conditions. The European Medicines Agency identifies Omalizumab as the active substance in Xolair and lists indications including severe allergic asthma, chronic spontaneous urticaria and severe chronic rhinosinusitis with nasal polyps.
The mechanism of action is based on the antibody's ability to bind circulating IgE. This decreases free IgE concentrations and subsequently reduces FcεRI receptor expression on relevant immune cells. In allergic asthma, this can reduce IgE-mediated inflammatory activity.
Omalizumab has therefore become an important molecule in the field of biological medicines, monoclonal antibody development and anti-IgE therapies.
Manufacturing Omalizumab is fundamentally different from manufacturing conventional chemical APIs. As a recombinant monoclonal antibody, its production involves biological expression systems, cell culture, downstream purification and extensive analytical characterization.
FDA identifies CHO cell suspension culture as the production system for Omalizumab.
For a biological API such as Omalizumab, quality evaluation generally focuses on critical quality attributes including molecular identity, purity, aggregation, charge variants, glycosylation, potency, protein concentration, host-cell-derived impurities, residual process-related impurities and microbiological quality.
The exact acceptance criteria for these attributes are generally established within the manufacturer's validated specification and applicable regulatory filing. They should therefore not be replaced with generic small-molecule API limits.
Quality control of Omalizumab API requires a biological-product approach. Analytical characterization may involve techniques such as chromatographic analysis, electrophoretic methods, peptide mapping, mass spectrometry, size-exclusion analysis, charge-variant analysis and biological or cell-based potency testing, depending on the approved analytical control strategy.
For a monoclonal antibody, identity and biological activity are particularly important because the molecule's therapeutic performance depends not only on its amino-acid sequence but also on its higher-order structure and other product-quality attributes.
WHO's guidance for monoclonal antibodies emphasizes that quality control of these products requires consideration of the biological nature and complex structural characteristics of monoclonal antibodies and related products.
Omalizumab Bulk API refers to the active biological substance intended for further pharmaceutical manufacturing or development rather than the finished dosage form. Because Omalizumab is a biologic, bulk-material handling and storage requirements should be determined according to the validated manufacturing process and approved product-specific conditions.
The finished Xolair presentations illustrate the distinction between the active substance and the final pharmaceutical product. FDA describes the marketed vial presentation as a sterile, preservative-free, lyophilized powder, while newer presentations include prefilled syringes and autoinjectors. These are drug-product characteristics and should not automatically be entered as API specifications.
India has an established biotechnology and pharmaceutical manufacturing sector, including capabilities related to recombinant proteins and monoclonal antibodies. Organizations searching for an Omalizumab API Manufacturer India should evaluate the source based on biological manufacturing capability, quality systems, analytical characterization, process consistency, regulatory documentation and cold-chain requirements where applicable.
For Omalizumab API Manufacturer searches, technical identification should clearly specify that the required substance is Omalizumab, a recombinant humanized IgG1κ monoclonal antibody, rather than a chemically synthesized small molecule.
The principal chemical identifier is CAS 242138-07-4, while the FDA GSRS identifier is UNII 2P471X1Z11.
Proper documentation is particularly important when sourcing a biological API. A technical package for Omalizumab may include:
A major difference between Omalizumab and conventional APIs is the type of specification used. Parameters such as Loss on Drying, Residue on Ignition, Heavy Metals, Melting Point and Specific Rotation are not appropriate universal quality specifications for a recombinant monoclonal antibody.
For example, FDA describes Omalizumab as a protein with an approximate molecular weight of 149 kDa and a recombinant biological manufacturing process rather than defining it through conventional small-molecule physicochemical specifications.
Accordingly, your CMS should use N/A / Product-Specific Specification for fields where a universal numerical value cannot be responsibly verified. This is much safer and technically more accurate than inserting generic values such as "NMT 0.5%" or "pH 2.0–4.0."
Omalizumab is a specialized biological pharmaceutical API with established applications in allergic and inflammatory diseases. It is a recombinant humanized IgG1κ monoclonal antibody directed against human IgE, with an approximate molecular weight of 149 kDa. FDA confirms its recombinant DNA-derived nature and CHO-cell production system.
For organizations researching Omalizumab API Manufacturer in India, Omalizumab API Supplier India, Omalizumab Pharmaceutical API, Omalizumab Bulk API or Omalizumab Manufacturer India, technical evaluation should focus on biological identity, potency, purity, structural integrity, aggregation, glycosylation, process-related impurities and regulatory quality documentation.
Omalizumab should be specified and evaluated as a monoclonal antibody biological substance, not as a conventional small-molecule API. This distinction is essential when preparing a reliable technical specification, product page and pharmaceutical procurement dataset.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Melting Point | 150–160°C |