Description

Mepolizumab CAS NO 196078-29-2 is a humanized monoclonal antibody that specifically targets interleukin-5 (IL-5). This product is a critical active pharmaceutical ingredient (API) for the formulation of targeted biologic therapies. It is primarily required by pharmaceutical manufacturers and advanced research institutions developing treatments for severe eosinophilic conditions, such as asthma and hypereosinophilic syndrome.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of biologic drug products targeting IL-5.
• Primary component in the formulation of Nucala® (mepolizumab) and other biosimilar or branded therapeutics.
• Critical raw material for clinical research and development of novel treatments for eosinophilic diseases.
• Reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Used in preclinical and clinical studies to investigate the role of IL-5 in inflammatory pathways.
• Essential for process development and scale-up activities in biopharmaceutical manufacturing.

Basic Information

Product Name	Mepolizumab
CAS No.	196078-29-2
Molecular Formula	C~2100~H~3220~N~560~O~660~S~20~ (Approximate for IgG1 antibody)
Molecular Weight	Approx. 146,000 - 149,000 Da
Synonyms	Mepolizumab; SB-240563; Anti-IL-5 Monoclonal Antibody; IL-5 Inhibitor; Nucala (Brand Name); hIL-5 mAb; GlaxoSmithKline 240563; Immunoglobulin G1, anti-(human interleukin 5) (human-mouse monoclonal SB-240563 γ1-chain), disulfide with human-mouse monoclonal SB-240563 light chain, dimer
EINECS	Contact for details

Quality Control

Our Mepolizumab is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting stringent specifications for biologic APIs. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for critical quality attributes including purity by SE-HPLC, monomer content, biological activity, endotoxin levels, and host cell protein residuals. Production adheres to cGMP guidelines suitable for advanced clinical and commercial applications.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C or below. Avoid repeated freeze-thaw cycles. Under ambient conditions for short-term handling, maintain at 2-8°C. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SE-HPLC, Monomer)	≥ 98.0%
Assay (Protein Content)	95.0% - 105.0% of label claim
Potency (Cell-Based Bioassay)	90% - 125% of reference
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Host Cell DNA	< 10 pg/mg
pH	6.0 - 7.5 (for solution)
Moisture Content (KFT)	< 3.0% (for lyophilized powder)

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