Description

Fremanezumab is a fully humanized monoclonal antibody (mAb) designed as a targeted therapeutic agent. It functions as a highly specific calcitonin gene-related peptide (CGRP) antagonist, offering a novel mechanism of action for preventive treatment. This product is essential for pharmaceutical manufacturers and research institutions developing advanced biologic therapies for chronic neurological conditions. It is supplied as a high-purity active pharmaceutical ingredient (API) under stringent quality control protocols.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of injectable biologic drugs for migraine prevention.
• Clinical Research: Utilization in preclinical and clinical studies to investigate the efficacy and safety of CGRP pathway inhibition.
• Biosimilar Development: Serves as a reference standard for companies developing biosimilar versions of CGRP antagonist therapies.
• Drug Delivery System Research: Used in studies exploring novel delivery mechanisms for monoclonal antibodies, such as sustained-release formulations.
• Biochemical Research: Application in in-vitro assays and studies to understand CGRP receptor binding kinetics and signal transduction.

Basic Information

Item	Detail
Product Name	Fremanezumab
CAS No.	1655501-53-3
Molecular Formula	Contact for details
Molecular Weight	Approx. 146 kDa
Synonyms	TEV-48125; Fremanezumab-vfrm; AJOVY (Brand Name); Anti-CGRP monoclonal antibody; LBR-101; RN-307; PF-04427429
EINECS	Contact for details

Quality Control

Our Fremanezumab is manufactured and tested under a quality management system designed for biologic APIs. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A Certificate of Analysis (COA) documenting critical quality attributes including purity by SE-HPLC, host cell protein levels, endotoxin content, and sterility is provided with every shipment.

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. The product is hygroscopic (moisture-sensitive) and must be handled under controlled, low-humidity conditions to maintain stability and prevent degradation.

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)	≥ 98.0% (Monomer)
Protein Content (UV)	95.0% - 105.0% of label claim
Potency (Cell-based assay)	90% - 115% of reference
Endotoxin	< 1.0 EU/mg
Host Cell Proteins (HCP)	< 100 ppm
Sterility	Sterile

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