Description

Vedolizumab is a humanized monoclonal antibody designed for targeted therapeutic intervention. Its primary value lies in its selective action against the α4β7 integrin, a key mediator of gut-specific lymphocyte trafficking. This makes it a critical active pharmaceutical ingredient (API) for the formulation of advanced biologic drugs. It is essential for pharmaceutical manufacturers and research institutions developing treatments for moderate to severe ulcerative colitis and Crohn's disease.

Application

• Primary Active Pharmaceutical Ingredient (API) in biologic drug formulations for inflammatory bowel disease (IBD).
• Key component in the manufacture of finished dosage forms for targeted immunosuppressive therapy.
• Critical material for bioanalytical research and pharmacokinetic/pharmacodynamic (PK/PD) studies.
• Reference standard for quality control and assay development in pharmaceutical laboratories.
• Starting material for the development of novel conjugate drugs or next-generation biologics.
• Essential reagent in preclinical and clinical research investigating leukocyte migration and gut immunity.

Basic Information

Product Name	Vedolizumab
CAS No.	943609-66-3
Molecular Formula	C6528H10060N1732O2016S44
Molecular Weight	Approx. 147 kDa
Synonyms	MLN0002; LDP-02; Anti-Human Integrin alpha4beta7 Monoclonal Antibody; Entyvio (Brand Name); Vedolizumab (USAN); Immunoglobulin G1, anti-(human integrin α-4 β-7 heterodimer) (human-mouse monoclonal MLN02 gamma1-chain), disulfide with human-mouse monoclonal MLN02 light chain, dimer; TNX-562; Recombinant Humanized Anti-α4β7 Integrin IgG1κ Monoclonal Antibody
EINECS	Contact for details

Quality Control

Our Vedolizumab is manufactured and tested under strict quality management systems. Each batch is subjected to a comprehensive battery of analytical tests, including but not limited to identity confirmation, purity assessment by multiple orthogonal methods (e.g., SEC-HPLC, CE-SDS), potency analysis, and rigorous testing for process-related impurities and contaminants. We provide full traceability and Certificates of Analysis (COA) are available for every lot, ensuring compliance with cGMP and ICH guidelines for biopharmaceuticals.

Storage

Preserve in a tightly closed container, protected from light. Store at the recommended temperature as specified on the Certificate of Analysis, typically at 2-8°C for long-term stability. This product is hygroscopic (moisture-sensitive) and must be protected from humidity. Avoid repeated freeze-thaw cycles.

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)	Heavy Chain & Light Chain bands present; ≥ 95.0% Purity
Potency (Cell-Based Assay)	Within defined range
Protein Content (A280)	Within defined range
pH	6.0 - 7.0 (for solution)
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg
Sterility (for aseptic fill)	Sterile

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