Description

Ranibizumab is a recombinant humanized monoclonal antibody fragment (Fab) designed for therapeutic use. This highly specific biologic agent is engineered to bind and inhibit vascular endothelial growth factor A (VEGF-A), a key signaling protein involved in pathological angiogenesis and vascular permeability. It is an essential active pharmaceutical ingredient (API) for the formulation of ophthalmic solutions, primarily serving the needs of pharmaceutical manufacturers and advanced biopharmaceutical research institutions focused on developing treatments for retinal diseases.

Application

• Ophthalmic Pharmaceutical Manufacturing: Primary use as the active ingredient in injectable solutions for treating neovascular (wet) age-related macular degeneration (AMD).
• Retinal Disease Therapeutics: Formulation component for therapies targeting diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
• Biopharmaceutical Research & Development: Critical reference standard and material for preclinical and clinical studies investigating anti-VEGF mechanisms of action.
• Biosimilar Development: Serves as the reference molecule for companies developing and validating biosimilar versions of the innovator product.
• Advanced Drug Delivery Systems: Used in research for novel sustained-release formulations, including implants and microparticles, to extend therapeutic duration.

Basic Information

Product Name	Ranibizumab
CAS No.	347396-82-1
Molecular Formula	C2158H3282N562O669S12
Molecular Weight	~48 kDa
Synonyms	Ranibizumab; rhuFab V2; Anti-VEGF Fab; Lucentis (Trade Name); Recombinant Humanized Anti-VEGF Monoclonal Antibody Fragment; VEGF Inhibitor Fab; Monoclonal Antibody Fragment Ranibizumab; VEGF-A Inhibitor
EINECS	Contact for details

Quality Control

Our Ranibizumab is manufactured under strict cGMP (current Good Manufacturing Practice) conditions to ensure the highest standards of purity, potency, and consistency. Each batch undergoes a comprehensive battery of analytical tests, including identity confirmation by peptide mapping and mass spectrometry, purity assessment by size-exclusion and reverse-phase HPLC, and rigorous testing for biological activity, endotoxins, and process-related impurities. Certificates of Analysis (COA) detailing all specifications and test results are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized (freeze-dried) powder at -20°C or below. Once reconstituted in appropriate buffer, the solution should be used immediately or stored at 2-8°C for short periods as validated. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or cake
Identification (Peptide Map)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% Monomer
Purity (RP-HPLC)	≥ 95.0% Main Peak
Potency (Cell-based Bioassay)	90% - 115% of reference
Protein Content (A280)	Within approved range
Endotoxin	< 1.0 EU/mg
Residual Host Cell DNA	< 10 pg/mg
Residual Protein A	< 10 ppm
Moisture Content (KF)	< 3.0%

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