Iparomlimab is a humanized monoclonal antibody of the immunoglobulin G4 kappa (IgG4κ) class that specifically targets programmed cell death protein 1 (PD-1), also known as CD279 or PDCD1. It is also known by the development code QL-1604 and is designed to block the inhibitory PD-1/PD-L1 and PD-1/PD-L2 immune checkpoint pathways.
Iparomlimab is a recombinant biological drug substance produced using mammalian cell culture technology. The antibody is composed of humanized monoclonal antibody chains and belongs to the IgG4 subclass. It recognizes human PD-1 and can interfere with PD-1-mediated inhibitory signaling, thereby supporting T-cell immune activity against tumor cells.
Iparomlimab has CAS Number 2417649-33-1 and FDA UNII FN3VWV28BC. Unlike conventional chemically synthesized pharmaceutical APIs, Iparomlimab is a large protein molecule and therefore does not have a conventional small-molecule molecular formula. Its reported molecular weight is approximately 146.7 kDa.
Iparomlimab is characterized as a human IgG4 kappa monoclonal antibody. The antibody is directed against human programmed cell death protein 1 (PD-1/CD279/PDCD1). Its biological activity is based on binding to PD-1 and blocking immune checkpoint signaling.
PD-1 is an inhibitory immune checkpoint receptor expressed on immune cells including activated T cells. Binding of PD-1 to its ligands PD-L1 and PD-L2 can suppress T-cell activity. Iparomlimab binds to human PD-1 and inhibits this checkpoint pathway, potentially restoring or enhancing T-cell-mediated immune responses against tumor cells.
Iparomlimab has been developed as an anti-PD-1 immunotherapeutic agent for oncology applications. Clinical investigation has evaluated Iparomlimab in patients with advanced solid tumors. Its therapeutic development is based on immune checkpoint inhibition through selective targeting of PD-1.
As a biological monoclonal antibody, Iparomlimab requires characterization using protein and immunological analytical techniques rather than conventional small-molecule API tests. Relevant analytical approaches may include size-exclusion chromatography, SDS-PAGE, protein concentration determination, purity assessment, identity testing and binding or functional activity assays.
Product-specific acceptance criteria should be established according to the applicable manufacturing process, regulatory requirements and batch-specific Certificate of Analysis. Numerical purity or assay values should not be assigned to the generic substance unless supported by the applicable product specification.
Iparomlimab is a biological protein and requires controlled storage conditions to maintain molecular integrity and biological activity. Research-grade product information recommends storage according to the applicable Certificate of Analysis, with protection from repeated freeze-thaw cycles. The exact storage condition should be taken from the manufacturer-specific specification for the supplied material.
Iparomlimab can be supplied as a biological monoclonal antibody for pharmaceutical development, analytical research and other qualified applications. Availability, presentation, formulation, concentration, packaging and regulatory documentation should be confirmed according to the specific batch and intended application.
For Iparomlimab requirements, customers can request product specifications, Certificate of Analysis, analytical documentation, formulation details, packaging information and regulatory documentation. Biological drug substance specifications should be reviewed against the applicable quality and regulatory requirements before procurement.
| Parameter | Specification |
|---|---|
| Appearance | 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% |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |