Description

Anifrolumab is a high-purity, human monoclonal antibody specifically designed to target the type I interferon receptor subunit 1. This product is critical for advanced pharmaceutical research and development, offering a targeted mechanism of action for modulating immune system pathways. It is primarily utilized by biopharmaceutical companies and research institutions engaged in the development of novel therapeutics for autoimmune and inflammatory diseases.

Application

• Primary active pharmaceutical ingredient (API) in biologic drug formulations.
• Reference standard for analytical method development and validation in QC laboratories.
• Critical reagent for preclinical and clinical research studies targeting type I interferon signaling.
• Key material for the development of biosimilar and bio-better therapeutic candidates.
• Used in immunological assays and diagnostic test development.
• Essential component for stability studies and formulation optimization.

Basic Information

Product Name	Anifrolumab
CAS No.	1326232-46-5
Molecular Formula	C6448H9916N1704O2018S46
Molecular Weight	Approx. 145 kDa
Synonyms	MEDI-546; Anifrolumab-fnia; Saphnelo; Anti-IFNAR1 Antibody; Type I Interferon Receptor Alpha Chain Blocker; IFNAR1 Antagonist; Immunoglobulin G1, anti-(human interferon alpha/beta receptor subunit 1) (human monoclonal MEDI-546 gamma1-chain), disulfide with human monoclonal MEDI-546 κ-chain, dimer
EINECS	Contact for details

Quality Control

Our Anifrolumab is manufactured 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 pharmaceutical-grade biologics. Certificates of Analysis (COA) detailing specifications such as purity by SEC-HPLC, host cell protein content, endotoxin levels, and biological activity are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C to -80°C. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive) and should be handled under controlled conditions to maintain integrity.

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)
Protein Content (UV)	95.0 - 105.0% of label claim
Potency (Cell-based assay)	90.0 - 115.0% of reference
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Sterility (where applicable)	Sterile

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