Description

Nivolumab CAS NO 946414-94-4 is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that functions as a programmed cell death-1 (PD-1) immune checkpoint inhibitor. This product is critical for advanced pharmaceutical research and development, enabling targeted immunotherapy approaches. It is primarily required by biopharmaceutical companies, clinical research organizations, and academic institutions engaged in oncology drug discovery, bioassay development, and reference standard preparation.

Application

• Primary reference standard for the quality control and analytical testing of commercial Nivolumab drug substance and drug products.
• Critical reagent in bioanalytical method development and validation for pharmacokinetic (PK) and immunogenicity (ADA) studies.
• Research tool for investigating PD-1/PD-L1 pathway biology and mechanisms of immune checkpoint inhibition.
• Component in the development and calibration of cell-based bioassays to measure biological activity.
• Use in formulation studies for biosimilar development and comparability exercises.
• Non-clinical research applications to support investigative new drug (IND) filings.

Basic Information

Product Name	Nivolumab
CAS No.	946414-94-4
Molecular Formula	C6402H9872N1696O1998S46
Molecular Weight	Approx. 143.6 kDa
Synonyms	Nivolumab; BMS-936558; MDX-1106; ONO-4538; Anti-PD-1 Monoclonal Antibody; Opdivo (Trade Name); Immunoglobulin G4, Anti-(Human Programmed Cell Death Protein 1) (Human-Mus musculus Monoclonal BMS-936558 γ4-chain), Disulfide with Human-Mus musculus Monoclonal BMS-936558 Light Chain, Dimer
EINECS	Contact for details

Quality Control

Our Nivolumab is manufactured and controlled under a quality management system. Each batch is subjected to a comprehensive panel of analytical tests, including but not limited to identity confirmation by mass spectrometry, purity assessment by size-exclusion and capillary electrophoresis, biological activity in a cell-based assay, and rigorous testing for process-related impurities. A detailed Certificate of Analysis (COA) documenting compliance with stringent specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C to -70°C. Avoid repeated freeze-thaw cycles. Upon receipt and for short-term use, store at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spec)	Consistent with Nivolumab
Purity (SEC-HPLC)	≥ 98.0% Monomer
Purity (CE-SDS, Reduced)	≥ 95.0% Main peak
Protein Content (A280)	90% - 110% of label claim
Biological Activity (Cell-based Assay)	Meets acceptance criteria
Endotoxin	< 1.0 EU/mg
Sterility (where applicable)	Sterile

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