Description

Belimumab is a fully human monoclonal antibody specifically designed to target and inhibit the B-lymphocyte stimulator (BLyS) protein. This targeted mechanism of action makes it a critical therapeutic agent for modulating B-cell activity in autoimmune disorders. It is primarily utilized by pharmaceutical manufacturers and research institutions focused on advanced biologic therapies. Our supply ensures high purity and consistency, meeting the stringent demands of global biopharmaceutical production and development.

Application

• Active Pharmaceutical Ingredient (API): Primary use as the key biologic component in finished drug products for the treatment of systemic lupus erythematosus (SLE).
• Biopharmaceutical Research: Serves as a critical reference standard and investigational material in preclinical and clinical studies for autoimmune diseases.
• Drug Formulation Development: Used in the development and optimization of stable liquid or lyophilized parenteral formulations.
• Biosimilar Development: Acts as a reference molecule for the analytical characterization and development of biosimilar candidates.
• Process Development & Scale-up: Employed in upstream and downstream process development for mammalian cell culture-based production.

Basic Information

Product Name	Belimumab
CAS No.	356547-88-1
Molecular Formula	C6848H10544N1820O2108S44
Molecular Weight	Approx. 147 kDa
Synonyms	Benlysta; LymphoStat-B; Anti-BLyS Monoclonal Antibody; Human Anti-BLyS IgG1λ; BIIB023; Belimumab (USAN/INN); Recombinant Human Anti-BLyS IgG1 Lambda Monoclonal Antibody
EINECS	Contact for details

Quality Control

Our Belimumab 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 Q6B guidelines for biotechnological products. A detailed Certificate of Analysis (COA) is provided, documenting critical quality attributes such as purity by SEC-HPLC, charge variant profile, biological activity, and endotoxin levels.

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) and should be handled under controlled conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spec)	Conforms
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Potency (Cell-based Bioassay)	90% - 110% of Reference Standard
Protein Content	As per COA
Endotoxins	< 1.0 EU/mg
Host Cell Proteins	< 100 ppm
Sterility (where applicable)	Sterile

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