Ramucirumab is a recombinant human IgG1 monoclonal antibody and a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist. It specifically binds to VEGFR2 and blocks activation by its ligands, including VEGF-A, VEGF-C and VEGF-D. This inhibits VEGFR2-mediated signaling involved in endothelial-cell proliferation, migration and tumor angiogenesis.
Ramucirumab is a biological pharmaceutical active ingredient produced using genetically engineered mammalian NS0 cells. The FDA describes ramucirumab as having an approximate molecular weight of 147 kDa.
Ramucirumab is used in oncology formulations for several approved cancer indications, including gastric or gastroesophageal junction adenocarcinoma, non-small cell lung cancer, colorectal cancer and hepatocellular carcinoma.
Product Name: Ramucirumab
API Category: Biological API / Monoclonal Antibody
Therapeutic Class: Antineoplastic / Antiangiogenic
Drug Class: VEGFR2 Antagonist
CAS Number: Not applicable as a conventional small-molecule API identifier
Molecular Formula: Not applicable; recombinant monoclonal antibody
Approximate Molecular Weight: 147 kDa
Biological Source / Expression System: Genetically engineered mammalian NS0 cells
Brand: CYRAMZA
INN: Ramucirumab
Protein Class: Recombinant human IgG1 monoclonal antibody
Ramucirumab is a protein biologic rather than a conventional small-molecule chemical API, so parameters such as molecular formula, exact mass, melting point and small-molecule physicochemical descriptors are not appropriately represented as standard API specifications.
Ramucirumab is a recombinant human IgG1 monoclonal antibody designed to specifically recognize and bind vascular endothelial growth factor receptor 2 (VEGFR2).
Because it is a large recombinant protein, its characterization relies on biological and biophysical analytical techniques rather than conventional small-molecule chemical characterization alone.
The FDA identifies an approximate molecular weight of 147 kDa and states that ramucirumab is produced in genetically engineered mammalian NS0 cells.
The marketed injectable formulation is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution at 10 mg/mL. The formulation contains glycine, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride and Water for Injection, with a formulation pH of 6.0.
Ramucirumab is an established oncology biologic used for the treatment of specified advanced or metastatic cancers.
FDA-approved applications include:
Depending on the indication, ramucirumab may be administered as a single agent or in combination with chemotherapy or targeted therapy.
Ramucirumab specifically binds to VEGFR2 and blocks binding of the VEGF ligands VEGF-A, VEGF-C and VEGF-D.
This prevents ligand-stimulated activation of VEGFR2 and inhibits downstream processes including endothelial-cell proliferation and migration. By interfering with VEGFR2 signaling, ramucirumab inhibits angiogenesis that supports tumor growth.
As a recombinant monoclonal antibody, Ramucirumab requires a biological-product characterization strategy rather than conventional small-molecule API testing alone.
Quality evaluation may include:
Numerical release limits for these attributes are product-specific and manufacturing-process dependent and should not be presented as universal values without an applicable regulatory or pharmacopoeial specification.
Ramucirumab is produced using genetically engineered mammalian NS0 cells. Manufacturing of the biological API involves controlled cell-culture production followed by purification and formulation processes designed to maintain antibody identity, purity, potency and structural integrity.
Typical manufacturing controls may include:
The FDA label specifies the approximate molecular weight, expression system, concentration, appearance and formulation pH.
Ramucirumab injection is supplied as a 10 mg/mL sterile solution in single-dose vials:
The current FDA labeling specifies storage of vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. The vial should not be frozen or shaken.
Typical documentation for a biological API may include:
Ramucirumab is a complex recombinant monoclonal antibody requiring specialized biological manufacturing and analytical characterization.
A qualified Ramucirumab API Manufacturer in India should maintain appropriate controls across cell culture, purification, viral clearance, protein characterization, potency testing, microbiological quality and cold-chain storage.
Because Ramucirumab is a biological API, its quality specifications should be established according to the validated manufacturing process, regulatory requirements and product-specific analytical methods rather than applying small-molecule API specifications.
| 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% |
| pH (1% Solution) | 6.0 |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |