Emapalumab is a recombinant human monoclonal antibody that binds to and neutralizes interferon gamma (IFN-γ). It is a targeted biological therapy used in the treatment of hemophagocytic lymphohistiocytosis (HLH). The FDA label identifies emapalumab-lzsg as a monoclonal antibody that neutralizes IFN-γ.
Emapalumab is a biological pharmaceutical ingredient rather than a conventional small-molecule API. Its development and quality control therefore require specialized characterization of protein identity, purity, aggregation, glycosylation, charge variants and biological potency.
The FDA originally approved emapalumab for adult and pediatric patients with primary HLH with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy. In 2025, the labeled indication was expanded to include HLH/macrophage activation syndrome associated with known or suspected Still's disease in specified patients.
Emapalumab is a specialized anti-IFN-γ monoclonal antibody relevant to pharmaceutical and biopharmaceutical research involving immune-mediated hyperinflammatory disorders.
| 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% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |