Description

Daratumumab CAS NO 945721-28-8 is a fully human monoclonal antibody (mAb) specifically targeting CD38, a glycoprotein highly expressed on the surface of multiple myeloma cells. This targeted mechanism of action makes it a cornerstone therapeutic agent in oncology, offering a significant advancement in treatment efficacy. It is primarily utilized by pharmaceutical manufacturers, biotechnology companies, and clinical research organizations for the development and production of advanced therapies for hematologic malignancies.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in commercial drug products for the treatment of multiple myeloma.
• Combination Therapy Formulations: Used in combination with other standard-of-care regimens, such as lenalidomide and dexamethasone or bortezomib and dexamethasone, to enhance therapeutic outcomes.
• Clinical Research & Development: Serves as a critical reagent and reference standard in preclinical studies and clinical trials for new oncology indications.
• Biosimilar Development: Acts as the reference product for companies developing biosimilar versions of daratumumab.
• Diagnostic & Assay Development: Utilized in the development of companion diagnostic tests and analytical assays to monitor CD38 expression and treatment response.

Basic Information

Product Name	Daratumumab
CAS No.	945721-28-8
Molecular Formula	C6466H10006N1726O2010S44
Molecular Weight	Approx. 145 kDa
Synonyms	Daratumumab; Anti-CD38 Monoclonal Antibody; HuMax-CD38; JNJ-54767414; Darzalex (trade name); IgG1κ, anti-(human CD38) (human monoclonal JNJ-54767414 γ1-chain), disulfide with human monoclonal JNJ-54767414 κ-chain, dimer; UNII-4Z63YK6E0E
EINECS	Not applicable for biopharmaceuticals

Quality Control

Our Daratumumab is manufactured under strict quality systems. Each batch is subjected to a comprehensive panel of analytical tests to ensure identity, purity, potency, and safety, meeting the stringent requirements for biopharmaceutical active substances. Certificates of Analysis (COA) detailing specifications for purity (by SEC-HPLC and CE-SDS), potency (cell-based bioassay), host cell protein (HCP) levels, and endotoxin content are provided and support compliance with relevant ICH Q6B guidelines.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C to -80°C. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration indicated on the certificate of analysis.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (SEC-HPLC / CE-SDS)	Conforms to reference standard
Purity (Monomer by SEC-HPLC)	≥ 98.0%
Purity (CE-SDS, Reduced)	Heavy Chain & Light Chain bands present
Potency (Cell-based Bioassay)	90% - 110% of reference
Protein Concentration (A280)	As per COA
pH	5.5 - 6.5
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm

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