Description

Dinutuximab is a chimeric monoclonal antibody specifically designed to target the GD2 disialoganglioside expressed on neuroblastoma cells. This targeted immunotherapy is a critical component in the treatment of high-risk neuroblastoma in pediatric patients, offering a mechanism to induce antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) against tumor cells. It is essential for pharmaceutical manufacturers, clinical research organizations, and biotechnology companies engaged in the development and production of advanced oncological therapeutics.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in the formulation of targeted cancer immunotherapies.
• High-Risk Neuroblastoma Treatment: A key therapeutic agent in combination regimens for pediatric patients with high-risk neuroblastoma.
• Clinical Research & Development: Serves as a critical reference standard and material for preclinical studies and clinical trials in oncology.
• Biopharmaceutical Manufacturing: Used in the large-scale GMP production of monoclonal antibody-based drugs.
• Drug Conjugate Development: Potential candidate as a targeting moiety for antibody-drug conjugates (ADCs) in next-generation cancer therapies.

Basic Information

Product Name	Dinutuximab
CAS No.	1363687-32-4
Molecular Formula	Contact for details
Molecular Weight	Approx. 150 kDa
Synonyms	Ch14.18; Dinutuximab beta; Unituxin; Anti-GD2 monoclonal antibody ch14.18; Immunoglobulin G1, anti-(human disialoganglioside GD2) (human-mouse monoclonal ch14.18 γ1-chain), disulfide with human-mouse monoclonal ch14.18 κ-chain, dimer
EINECS	Contact for details

Quality Control

Our Dinutuximab is manufactured under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing specifications for purity (by SEC-HPLC and CE-SDS), potency (cell-based bioassay), endotoxin levels, and sterility is provided with every shipment to guarantee compliance for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -80°C. Avoid repeated freeze-thaw cycles. Under ambient conditions, this product is hygroscopic (moisture-sensitive) and must be handled in a controlled environment to maintain integrity.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Immunoassay)	Complies
Purity (SEC-HPLC)	≥ 98.0% Monomer
Purity (CE-SDS, Reduced)	Heavy Chain & Light Chain bands present
Potency (Cell-based Cytotoxicity)	Within specified range
Protein Content (A280)	As per COA
Endotoxin	< 1.0 EU/mg
Sterility	Sterile

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