Description

Crizanlizumab is a humanized monoclonal antibody designed for targeted therapeutic intervention. This high-purity biological agent is critical for pharmaceutical research and development, offering a specific mechanism of action for advanced clinical studies. It is primarily utilized by biopharmaceutical companies and research institutions engaged in the development of novel treatments for specific hematological conditions.

Application

• Pharmaceutical Active Ingredient (API): Serves as the core active component in formulated drug products for clinical trials and commercial manufacturing.
• Biomedical Research: Used as a critical reagent in in vitro and in vivo studies to investigate disease pathways and therapeutic efficacy.
• Preclinical & Clinical Development: Essential for toxicity studies, pharmacokinetic/pharmacodynamic (PK/PD) modeling, and Phase I-III clinical trials.
• Reference Standard: Acts as a high-purity standard for analytical method development, validation, and quality control testing of drug substances and products.
• Process Development & Scale-Up: Supports optimization of upstream cell culture and downstream purification processes in biomanufacturing.

Basic Information

Item	Details
Product Name	Crizanlizumab
CAS No.	1690318-25-2
Molecular Formula	Contact for details
Molecular Weight	Approx. 145 kDa (Contact for exact specification)
Synonyms	SEG101; Crizanlizumab-tmca; ADX-629; Anti-P-Selectin Monoclonal Antibody (humanized); AJM300; Monoclonal Antibody Anti-P-Selectin; P-Selectin Inhibitor; Immunoglobulin G1, anti-(human P-selectin) (human-mouse monoclonal SEG101 γ1-chain), disulfide with human-mouse monoclonal SEG101 κ-chain, dimer
EINECS	Not listed / Contact for details

Quality Control

Our Crizanlizumab is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, potency, and safety. Release specifications align with ICH Q6B guidelines for biotechnological products. A comprehensive Certificate of Analysis (COA) detailing tests for purity (by SEC-HPLC and CE-SDS), biological activity, endotoxin, and host cell proteins is provided with each batch.

Storage

Preserve in the original container as supplied, tightly sealed, and 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 indicated on the certificate. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spec)	Conforms
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Purity (CE-SDS, Reduced)	≥ 95.0% (Main Peak)
Potency (Cell-Based Assay)	90.0% - 110.0% of Reference Standard
Protein Content (A280)	90.0% - 110.0% of Label Claim
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
pH	6.0 - 7.5 (for solution)

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