Description

Eptinezumab is a humanized monoclonal antibody specifically designed to target and inhibit the calcitonin gene-related peptide (CGRP) ligand, a key mediator in the pathophysiology of migraine. This targeted mechanism of action makes it a critical therapeutic agent for the preventive treatment of migraine in adults. It is primarily utilized by pharmaceutical manufacturers, biotechnology companies, and clinical research organizations engaged in the development and production of advanced biologic therapies. Eptinezumab CAS NO 1644539-04-7 represents a significant advancement in neurology-focused biologics, offering a solution for patients with frequent and debilitating migraine episodes.

Application

• Preventive Migraine Treatment: Primary therapeutic application for the prophylactic treatment of episodic and chronic migraine in adult patients.
• Pharmaceutical Active Ingredient: Serves as the key active pharmaceutical ingredient (API) in finished drug products, such as intravenous infusion solutions.
• Biopharmaceutical Research & Development: Used as a reference standard and investigational material in R&D for novel CGRP pathway inhibitors and next-generation migraine therapies.
• Clinical Trial Material: Supplied as a GMP-grade substance for use in Phase I-IV clinical studies to evaluate safety, efficacy, and dosage.
• Biosimilar Development: Acts as a critical comparator for companies developing biosimilar versions of this monoclonal antibody therapy.
• Academic & Mechanistic Studies: Employed in neuroscience and pharmacology research to further elucidate the role of CGRP in migraine and other neurological conditions.

Basic Information

Product Name	Eptinezumab
CAS No.	1644539-04-7
Molecular Formula	C6472H10012N1732O2010S46
Molecular Weight	Approx. 145 kDa
Synonyms	Eptinezumab-jjmr; VYEPTI™ (brand name); Anti-CGRP monoclonal antibody; ALD403; LY2951742 (related development code); Immunoglobulin G1, anti-(human calcitonin gene-related peptide) (human γ1-chain), disulfide with human κ-chain, dimer; Recombinant humanized anti-CGRP IgG1κ monoclonal antibody; CGRP ligand inhibitor
EINECS	Contact for details

Quality Control

Our Eptinezumab 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 a biopharmaceutical active substance. We provide full traceability and support regulatory submissions with detailed documentation. Certificates of Analysis (COA) are available upon request, detailing specifications and results for parameters such as assay, purity, host cell proteins, and endotoxin levels.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -70°C. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration specified on the certificate of analysis. Thaw under controlled conditions (e.g., 2-8°C) prior to use.

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
Assay (UV Spectroscopy)	90.0% - 110.0% of label claim
Protein Content	As per COA
Potency (Cell-Based Assay)	Within specified range
Host Cell Proteins (HCP)	≤ 100 ppm
Host Cell DNA	≤ 10 pg/mg
Endotoxin	< 1.0 EU/mg
pH	5.0 - 7.0 (for solution)

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