Racotumomab is a murine anti-idiotype monoclonal antibody developed as a therapeutic cancer vaccine. It is the 1E10 monoclonal antibody, an IgG1-kappa antibody that functionally mimics the tumor-associated ganglioside antigen N-glycolyl GM3 (NeuGcGM3) and stimulates an immune response against tumor cells expressing this antigen.
Racotumomab is identified by CAS 946832-34-4 and FDA GSRS UNII 52G405U1E5. It is a biologic rather than a conventional chemically synthesized small-molecule API.
Racotumomab is a full-length murine monoclonal antibody with an IgG1-kappa isotype. The antibody is directed against the idiotype of the P3 monoclonal antibody and consequently induces an immune response against NeuGcGM3-containing gangliosides expressed on malignant cells.
The antibody is associated with the therapeutic cancer-vaccine product Vaxira. Current Argentine product information lists 1.00 mg racotumomab per vial, together with aluminum hydroxide and formulation excipients.
| Parameter | Details |
|---|---|
| Product Name | Racotumomab |
| Synonym | 1E10 monoclonal antibody |
| CAS Number | 946832-34-4 |
| FDA UNII | 52G405U1E5 |
| Molecular Type | Monoclonal antibody |
| Antibody Format | Full-length antibody |
| Origin | Murine / mouse-derived |
| Isotype | IgG1 |
| Light Chain | Kappa |
| Approx. Molecular Weight | 146.13 kDa |
| Molecular Formula* | C₆₄₇₆H₉₉₂₂N₁₇₁₂O₂₀₄₈S₅₀ |
| Target/Specificity | Anti-idiotype P3 antibody; mimics NeuGcGM3 antigen |
| Therapeutic Class | Therapeutic cancer vaccine / monoclonal antibody |
| Biological Category | Antineoplastic immunotherapy |
*The formula and approximately 146.13 kDa molecular weight are database/recombinant-antibody reference representations and should not be treated as a universal release specification for the intact biological drug substance. A commercial antibody reference lists MW 146,133.55 Da.
Racotumomab is an anti-idiotype cancer vaccine designed to induce immune responses against NeuGcGM3 gangliosides, which are expressed on a range of malignant cells.
Documented therapeutic and development applications include:
Racotumomab has been approved in Argentina and Cuba and has been marketed for recurrent or advanced NSCLC.
Because Racotumomab is a monoclonal antibody, quality testing should follow biological-product/mAb principles rather than conventional small-molecule API testing.
WHO guidance for therapeutic monoclonal antibodies covers identity, purity, impurities, potency, physicochemical characterization, process-related impurities and other critical quality attributes.
Appropriate Racotumomab analytical characterization may include:
The Indian National Institute of Biologicals specifically states that therapeutic monoclonal antibodies are evaluated for physicochemical parameters and in-vitro biological activity, with testing according to pharmacopoeial or manufacturer in-house specifications where no monograph exists.
Manufacturing Racotumomab requires a controlled mammalian-cell expression and purification process appropriate for a therapeutic monoclonal antibody. Unlike a conventional synthetic API, the quality of Racotumomab depends on both molecular identity and biological function.
Important manufacturing controls include:
Racotumomab drug substance and finished biological products require validated temperature-controlled storage and protection from conditions that may cause protein aggregation or degradation.
The commercial Vaxira product is supplied as an injectable preparation containing racotumomab together with aluminum hydroxide and formulation components. Current Argentine product information identifies 1 mg racotumomab per vial.
For API/drug-substance handling, the actual storage temperature, container system and shelf life should be established from validated stability data rather than applying a generic small-molecule storage condition.
Racotumomab API documentation may include:
Racotumomab requires a specialized biological manufacturing and analytical-control strategy. Consistent antibody identity, purity, aggregation profile, biological potency and process-related impurity control are more relevant than conventional small-molecule parameters such as melting point, residue on ignition or specific rotation.
A suitable Racotumomab manufacturing program should therefore follow applicable monoclonal-antibody quality principles and use validated physicochemical and biological assays.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.2% |
| Total Impurities | NMT 1.0% |
| Melting Point | 150–200°C |