Description

Avelumab CAS NO 1537032-82-8 is a fully human monoclonal antibody designed as an immune checkpoint inhibitor, specifically targeting the programmed death-ligand 1 (PD-L1). This product matters as a critical active pharmaceutical ingredient (API) for the development and manufacture of advanced cancer immunotherapies. It is essential for pharmaceutical companies, biotechnology firms, and clinical research organizations engaged in oncology drug development, particularly for treatments targeting metastatic Merkel cell carcinoma and urothelial carcinoma.

Application

• Primary Active Pharmaceutical Ingredient (API) for the commercial manufacture of the immunotherapy drug Bavencio®.
• Critical component in pre-clinical and clinical research for novel PD-L1/PD-1 pathway-targeting cancer therapies.
• Used in the formulation of injectable biopharmaceutical products for the treatment of metastatic Merkel cell carcinoma (mMCC).
• Essential for the production of therapeutics for locally advanced or metastatic urothelial carcinoma (UC).
• Key reagent in bioanalytical development for pharmacokinetic (PK) and immunogenicity assays.
• Supplies research into combination therapies, pairing checkpoint inhibitors with other oncology agents.

Basic Information

Product Name	Avelumab
CAS No.	1537032-82-8
Molecular Formula	C6374H9848N1696O1998S46
Molecular Weight	Approx. 147 kDa
Synonyms	MSB0010718C; Anti-PD-L1 monoclonal antibody; Bavencio (trade name); Avelumab (INN); IgG1 lambda anti-PD-L1 monoclonal antibody; PD-L1 Inhibitor MSB0010718C; UNII-KXG2PJ551I
EINECS	Contact for details

Quality Control

Our Avelumab is manufactured under strict cGMP (current Good Manufacturing Practice) conditions suitable for pharmaceutical use. Quality is assured through a comprehensive battery of tests including identity confirmation, purity analysis, potency assays, and stringent impurity profiling. A detailed Certificate of Analysis (COA) is provided with each batch, documenting compliance with relevant pharmacopeial standards and in-house specifications for biopharmaceutical APIs.

Storage

Preserve in a tightly closed container, protected from light. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term stability, store frozen at -20°C to -70°C. Avoid repeated freeze-thaw cycles. Under recommended conditions, the product remains stable for the duration indicated on the certificate.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Potency (Cell-based Bioassay)	90% - 120% of reference
Protein Content (A280)	95% - 105% of label claim
Endotoxin (LAL)	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg
pH	5.5 - 6.5 (for solution)

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