Imdevimab is a recombinant human IgG1 monoclonal antibody developed to specifically target the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. It was developed as one component of the casirivimab–imdevimab antibody combination for targeted neutralization of SARS-CoV-2.
Imdevimab binds to an epitope on the SARS-CoV-2 spike RBD that is distinct from the epitope recognized by casirivimab. Together, the two antibodies can block interaction of the viral RBD with the human ACE2 receptor.
Imdevimab is a complex biological pharmaceutical ingredient manufactured using recombinant DNA technology in Chinese hamster ovary (CHO) cell culture. Because it is a monoclonal antibody, manufacturing and quality control require specialized biological production, purification and characterization processes.
Quality evaluation focuses on antibody identity, purity, aggregation, charge variants, glycosylation, potency, host-cell proteins, residual DNA and other process-related impurities.
CAS Number: 2415933-40-1
Molecular Formula: C6396H9882N1694O2018S42
Molecular Weight: Approximately 144.14 kDa
Molecule Type: Recombinant Human Monoclonal Antibody
Antibody Isotype: IgG1λ
Drug Class: Monoclonal Antibody
Target: SARS-CoV-2 Spike Protein RBD
Therapeutic Area: Infectious Diseases / Virology
The molecular formula, approximate molecular mass and CAS number are reported in regulatory product information.
Imdevimab binds to the receptor-binding domain of the SARS-CoV-2 spike protein. This binding interferes with the interaction between the viral spike RBD and the human ACE2 receptor, thereby inhibiting viral attachment and entry into susceptible host cells.
Imdevimab and casirivimab recognize non-overlapping epitopes, which was the basis for their development as a combination antibody therapy.
Imdevimab was developed primarily as part of casirivimab and imdevimab for:
However, regulatory status is jurisdiction- and variant-dependent. In the United States, the FDA revoked the EUA for casirivimab and imdevimab on December 13, 2024, and the product is no longer available for use there.
Imdevimab is produced using recombinant DNA technology in CHO cell suspension culture. Key manufacturing stages can include:
Each stage requires appropriate process controls and validation for a biological pharmaceutical product.
Imdevimab quality evaluation may include:
Imdevimab-containing pharmaceutical products require controlled storage conditions appropriate for the validated stability profile of the biologic. Regulatory product information describes the finished injection as a sterile, preservative-free solution and specifies controlled handling conditions.
Imdevimab is relevant to research involving:
Imdevimab is a recombinant human IgG1λ monoclonal antibody with CAS Number 2415933-40-1 and an approximate molecular weight of 144.14 kDa. It targets the SARS-CoV-2 spike protein receptor-binding domain and was developed for use with casirivimab as a neutralizing antibody combination.
| 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 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |