Tislelizumab API is a recombinant, humanized monoclonal antibody and an immune checkpoint inhibitor targeting the programmed cell death protein 1 (PD-1) receptor. It belongs to the immunoglobulin G4 (IgG4) monoclonal antibody class and is engineered with Fc modifications designed to minimize interaction with Fc gamma receptors.
Tislelizumab binds to PD-1 on T cells and blocks interaction with its ligands PD-L1 and PD-L2. This inhibition can restore T-cell-mediated antitumor immune responses and supports its use as an oncology biologic.
Swapnroop Pharma offers Tislelizumab API for pharmaceutical and biopharmaceutical development, formulation manufacturing and qualified bulk requirements.
Tislelizumab, also known as BGB-A317, is a recombinant anti-PD-1 monoclonal antibody produced using recombinant Chinese Hamster Ovary (CHO) cells.
The antibody consists of two heavy chains and two light chains. Each heavy chain contains 445 amino acid residues and each light chain contains 214 amino acid residues. The theoretical molecular weight calculated from the amino acid sequence is 144,080 Da, while the intact glycosylated antibody has an approximate molecular weight of 147 kDa.
Tislelizumab has been developed as an immune checkpoint inhibitor for oncology applications and is marketed as TEVIMBRA (tislelizumab-jsgr) in the United States.
Product Name: Tislelizumab
API Name: Tislelizumab
CAS Number: 1858168-59-8
Alternative Development Name: BGB-A317
UNII: 0KVO411B3N
Molecular Type: Recombinant Monoclonal Antibody
Antibody Class: Humanized IgG4
Target: Programmed Cell Death Protein 1 (PD-1)
Pharmacological Class: PD-1 Blocking Antibody / Immune Checkpoint Inhibitor
Production System: Recombinant Chinese Hamster Ovary (CHO) Cells
Heavy Chain: 445 amino acid residues
Light Chain: 214 amino acid residues
Total Amino Acid Residues: 1,318
Theoretical Molecular Weight: 144,080 Da
Approximate Intact Molecular Weight: 147 kDa
Dosage Form: Sterile solution for intravenous administration in the approved finished product
Tislelizumab binds to the PD-1 receptor expressed on T cells and prevents interaction between PD-1 and its ligands PD-L1 and PD-L2.
Blocking PD-1 signaling can remove an inhibitory pathway affecting T-cell activity and support immune-mediated antitumor responses.
Tislelizumab has Fc engineering intended to minimize binding to Fc gamma receptors and C1q, thereby reducing Fc-mediated effector functions such as antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis and complement-dependent cytotoxicity.
Tislelizumab is an oncology biologic used in the development and manufacture of immuno-oncology therapies.
Its pharmaceutical applications include:
Approved indications vary by jurisdiction and should be described according to the applicable regulatory label for the intended market.
Swapnroop Pharma provides Tislelizumab API for qualified pharmaceutical and biopharmaceutical customers requiring recombinant monoclonal antibody materials.
Tislelizumab is a biologic drug substance rather than a conventional small-molecule API. Accordingly, its quality evaluation relies on a combination of physicochemical, biochemical, purity, identity, potency and process-related impurity assessments.
Product specifications, analytical documentation, stability information and regulatory documentation can be supplied according to the applicable product grade and customer requirements.
Tislelizumab is suitable for qualified biopharmaceutical development and manufacturing requirements where recombinant monoclonal antibody drug substance is required.
Bulk supply conditions, storage requirements, container configuration and documentation should be established according to the actual drug-substance specification and applicable stability data.
Depending on product grade and customer requirements, documentation may include:
Tislelizumab drug substance is a protein biologic and requires controlled storage conditions based on validated stability data.
The EMA assessment documentation reports that the tislelizumab drug substance is stored frozen and that its established shelf life is supported by ICH-compliant stability studies.
The approved finished product is supplied as a sterile, preservative-free solution for intravenous administration.
Commercial handling and storage should always follow the actual manufacturer's approved specification and validated stability conditions.
For pharmaceutical and biotechnology companies seeking Tislelizumab API in India, Swapnroop Pharma provides product sourcing support for oncology biologic development, formulation and qualified manufacturing requirements.
Contact Swapnroop Pharma for Tislelizumab API availability, specifications, documentation, packaging and bulk commercial requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |