Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Toripalimab API manufacturer and supplier in India, supporting qualified pharmaceutical manufacturers, biotechnology companies, formulation developers, research organizations, and bulk procurement requirements.
Toripalimab is a recombinant, humanized IgG4-kappa monoclonal antibody targeting programmed cell death protein 1 (PD-1). It is also known as JS001, JS-001, TAB001, and toripalimab-tpzi. Toripalimab binds to PD-1 and blocks interaction with PD-L1 and PD-L2, thereby restoring T-cell-mediated antitumor immune activity.
Toripalimab has a CAS number of 1924598-82-2 and a molecular weight reported at approximately 147.3 kDa in the USAN structural record. Other regulatory characterization sources report an average molecular mass of approximately 149.7 kDa, reflecting the glycosylated antibody.
Toripalimab is a humanized IgG4-kappa monoclonal antibody produced using recombinant DNA technology in a Chinese hamster ovary (CHO) cell expression system. The antibody consists of two identical heavy chains of 452 amino acids and two identical light chains of 219 amino acids. It contains an N-linked glycosylation site at heavy-chain residue N302.
The antibody incorporates an S233P substitution to minimize Fab-arm exchange, an important structural characteristic of this modified IgG4 molecule.
Toripalimab is an immune checkpoint inhibitor used in oncology. It blocks PD-1 signaling by preventing PD-L1 and PD-L2 from binding to PD-1 on T cells. This mechanism helps restore antitumor immune responses.
In the United States, toripalimab-tpzi (LOQTORZI) was approved by the FDA in October 2023 for use with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma, and as a single agent for certain recurrent unresectable or metastatic nasopharyngeal carcinoma.
The European Medicines Agency lists Loqtorzi (toripalimab) for combination treatment of eligible patients with nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.
Swapnroop supports qualified customers requiring Toripalimab API / drug substance for pharmaceutical development, formulation, analytical, and commercial manufacturing applications.
As a monoclonal antibody, Toripalimab is not appropriately represented using conventional small-molecule API specifications such as assay 98–102%, melting point, residue on ignition, or loss on drying. Its quality is evaluated through a combination of identity, purity, protein concentration, structural characterization, biological activity, aggregation, charge variants, glycosylation, process-related impurities, and microbiological controls.
The approved LOQTORZI drug product is supplied as a sterile, preservative-free solution in a single-dose vial. Each vial contains 240 mg in 6 mL, equivalent to 40 mg/mL, and the finished product has a formulation pH of 6.0.
These values describe the finished drug product, not a universal bulk Toripalimab drug-substance specification.
Depending on the applicable supply arrangement, documentation may include:
Swapnroop Drugs & Pharmaceuticals provides Toripalimab API/drug-substance supply support for qualified pharmaceutical, biotechnology, formulation, research, and bulk procurement requirements.
| 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 |
| Melting Point | 150°C – 154°C |