Description

Benralizumab is a humanized monoclonal antibody designed to target the interleukin-5 receptor alpha (IL-5Rα). This product is a critical active pharmaceutical ingredient (API) for the formulation of targeted biologic therapies. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of advanced treatments for severe eosinophilic asthma and other inflammatory disorders.

Application

• Pharmaceutical API: Primary use as the active ingredient in biologic drug formulations.
• Therapeutic Development: For the treatment of severe eosinophilic asthma by depleting eosinophils.
• Clinical Research: Used in investigational studies for other eosinophil-driven diseases, such as chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilic granulomatosis with polyangiitis (EGPA).
• Biologic Manufacturing: Serves as a key component in large-scale GMP production of monoclonal antibody therapies.
• Reference Standard: Utilized as a high-purity standard in analytical and quality control laboratories.
• Drug Discovery: Employed in preclinical research to study IL-5 pathway inhibition and its therapeutic effects.

Basic Information

Product Name	Benralizumab
CAS No.	1044511-01-4
Molecular Formula	C6472H10012N1732O2016S44
Molecular Weight	Approx. 146 kDa
Synonyms	MEDI-563; Anti-IL5Rα monoclonal antibody; Fasenra (trade name); IL-5Rα inhibitor; Benralizumab-axnq; Immunoglobulin G1, anti-(human interleukin 5 receptor α-chain) (human-mouse monoclonal MEDI-563 γ1-chain), disulfide with human-mouse monoclonal MEDI-563 κ-chain, dimer
EINECS	Contact for details

Quality Control

Our Benralizumab is manufactured and tested under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, meeting the stringent requirements for a biologic API. Certificates of Analysis (COA) detailing specifications and results for parameters such as purity (by SEC-HPLC and CE-SDS), bioactivity, endotoxin levels, and host cell protein content are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at -20°C or below. Under these conditions, the product is stable for at least 24 months. Reconstituted or diluted solutions should be used immediately. The product is hygroscopic (moisture-sensitive) and must be protected from humidity.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (Mass Spec)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Purity (CE-SDS, Reduced)	Heavy Chain & Light Chain bands present, ≥ 95.0%
Potency (Cell-based Assay)	90% - 110% of reference
Protein Content (A280)	90% - 110% of label claim
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Residual DNA	< 10 pg/mg
Moisture (KFT)	< 3.0%

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