Eflapegrastim is a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF) biologic designed to stimulate neutrophil production. It consists of a recombinant G-CSF analog linked to the Fc fragment of human IgG4 through a polyethylene glycol (PEG)-derived linker, which extends its circulation time.
Eflapegrastim is classified as a long-acting myeloid growth factor and has been developed for the management of chemotherapy-induced neutropenia. Its G-CSF component promotes the proliferation and differentiation of neutrophil progenitor cells, supporting recovery of neutrophil counts following myelosuppressive chemotherapy.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical and biotechnology-related product information for Eflapegrastim API. Eflapegrastim is a recombinant protein biologic with a molecular weight of approximately 72 kDa and CAS Number 1384099-30-2.
The product is also known by identifiers including Eflapegrastim-xnst, HM10460A, HNK460 and SPI-2012. The FDA identifies the substance under UNII UT99UG9QJX.
Eflapegrastim acts through the granulocyte colony-stimulating factor pathway. The G-CSF component interacts with G-CSF receptors and promotes proliferation and differentiation of neutrophil precursor cells. The Fc component contributes to prolonged circulation and reduced clearance of the molecule.
Eflapegrastim is associated with supportive care in oncology, particularly for reducing the duration and severity of chemotherapy-induced neutropenia. FDA-approved Rolvedon (eflapegrastim-xnst) is administered subcutaneously approximately 24 hours after cytotoxic chemotherapy according to its prescribing information.
Eflapegrastim is a complex recombinant biologic. Quality evaluation should therefore include identity, purity, potency, protein-related impurities, aggregates, residual process-related impurities and other applicable biologic quality attributes according to the approved product or customer specification.
Note: Exact analytical acceptance criteria should be taken from the applicable approved specification, Certificate of Analysis (CoA), pharmacopoeial requirement where applicable, or customer-approved specification.
| 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) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |