Description

Tislelizumab is a humanized monoclonal antibody designed as a programmed cell death protein 1 (PD-1) inhibitor. This compound is a critical active pharmaceutical ingredient (API) in advanced immunotherapy, offering a targeted mechanism to block the PD-1 pathway and enhance the immune system's ability to fight cancer. It is essential for pharmaceutical manufacturers and research institutions developing innovative oncology treatments. The product is supplied under the identifier CAS NO 1858168-59-8.

Application

• Oncology Drug Manufacturing: Primary use as the active pharmaceutical ingredient (API) in the formulation of injectable immunotherapies for various cancers.
• Clinical Research & Development: Serves as a key reference standard and material for preclinical studies and clinical trials investigating PD-1 inhibition.
• Biopharmaceutical Synthesis: Used in the downstream processing and purification stages of monoclonal antibody production.
• Combinatorial Therapy Development: Employed in research to develop combination treatments with other chemotherapeutic or immunotherapeutic agents.
• Diagnostic Reagent Development: Potential use in the development of companion diagnostic assays to identify patient populations likely to respond to therapy.

Basic Information

Product Name	Tislelizumab
CAS No.	1858168-59-8
Molecular Formula	C6472H10028N1732O2016S46
Molecular Weight	Approx. 145 kDa
Synonyms	BGB-A317; Tislelizumab Injection; Anti-PD-1 Monoclonal Antibody BGB-A317; PD-1 Inhibitor BGB-A317; JS001 (historical); IBI308 (historical); BAT1306; Tislelizumab (USAN/INN)
EINECS	Contact for details

Quality Control

Our Tislelizumab is manufactured under strict cGMP (current Good Manufacturing Practice) guidelines to ensure the highest standards of purity and consistency for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including identity confirmation by mass spectrometry, purity assessment by size-exclusion and ion-exchange HPLC, and rigorous testing for bioburden, endotoxins, and host cell proteins. A comprehensive Certificate of Analysis (COA) documenting all release specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at -20°C or below. Reconstituted or liquid formulations should be stored at 2-8°C and used promptly. This product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spec)	Conforms
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Purity (CE-SDS)	≥ 95.0% (Reduced & Non-reduced)
Potency (Cell-based Bioassay)	90% - 120% of Reference Standard
Protein Content (A280)	90% - 110% of Label Claim
pH	5.5 - 6.5 (for solution)
Endotoxin	< 1.0 EU/mg
Bioburden	Meets Ph. Eur. 2.6.12 / USP <61>
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.