Description

Durvalumab is a high-affinity, human monoclonal antibody designed as a programmed cell death-ligand 1 (PD-L1) blocker. This compound is critical for its role in cancer immunotherapy, specifically by inhibiting the PD-1/PD-L1 pathway to help restore anti-tumor immune responses. It is primarily required by pharmaceutical manufacturers, biotechnology research institutions, and clinical diagnostic developers focused on oncology therapeutics and immuno-oncology research.

Application

• Oncological Therapeutics: As the active pharmaceutical ingredient (API) in the manufacture of finished drug products for the treatment of specific cancers, such as unresectable non-small cell lung cancer (NSCLC) and urothelial carcinoma.
• Biopharmaceutical Research: Used in preclinical and clinical research to study PD-L1 inhibition mechanisms, combination therapies, and novel immuno-oncology pathways.
• Reference Standard: Serves as a high-purity reference standard in analytical laboratories for quality control, method development, and validation of related biological assays.
• Drug Formulation Development: Employed in the development and optimization of stable parenteral formulations, including lyophilized powders and liquid solutions.
• Clinical Trial Materials: Supplied as a critical raw material for the production of clinical trial supplies under Good Manufacturing Practice (GMP) guidelines.

Basic Information

Product Name	Durvalumab
CAS No.	1428935-60-7
Molecular Formula	C6472H10012N1720O2016S46
Molecular Weight	Approx. 147 kDa
Synonyms	MEDI4736; Imfinzi (Trade Name); Anti-PD-L1 Monoclonal Antibody; Immunoglobulin G1, anti-(human protein B7-H1) (human-mouse monoclonal MEDI4736 γ1-chain), disulfide with human-mouse monoclonal MEDI4736 κ-chain, dimer; Anti-B7-H1; Anti-CD274; Durvalumab (USAN); UNII-28X28X9OKV
EINECS	Contact for details

Quality Control

Our Durvalumab is manufactured and controlled under a quality management system. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. Certificates of Analysis (COA) detailing specifications such as purity by SE-HPLC, host cell protein levels, and biological activity are provided.

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. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions upon opening.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spectrometry)	Conforms
Purity (SE-HPLC)	≥ 98.0% (Monomer)
Protein Content (UV Absorption)	95.0% - 105.0% of label claim
Potency (Cell-Based Bioassay)	90% - 125% of reference standard
pH	5.5 - 6.5 (for solution)
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Sterility (Membrane Filtration)	Sterile

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