Description

Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that specifically binds to and neutralizes vascular endothelial growth factor (VEGF). This targeted action is critical for inhibiting angiogenesis, the process of new blood vessel formation, which is a key driver in several pathological conditions. It is an essential active pharmaceutical ingredient (API) for the formulation of targeted biologic therapies, primarily serving the global pharmaceutical and biotechnology sectors in oncology and ophthalmology.

Application

• Oncological Therapeutics: Primary API for the manufacture of anti-cancer biologics targeting metastatic colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, renal cell carcinoma, and ovarian cancer.
• Ophthalmic Formulations: Key ingredient in intravitreal injections for treating neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).
• Biosimilar Development: Reference molecule for the research, development, and analytical characterization of bevacizumab biosimilars.
• Clinical Research: Used as a standard or investigational agent in preclinical studies and clinical trials exploring new anti-angiogenic therapies and combination regimens.
• Biopharmaceutical Manufacturing: Serves as a critical raw material for fill-finish operations in aseptic processing facilities under cGMP conditions.

Basic Information

Product Name	Bevacizumab
CAS No.	216974-75-3
Molecular Formula	C6638H10160N1720O2108S44
Molecular Weight	Approx. 149 kDa
Synonyms	Anti-VEGF Monoclonal Antibody; rhuMAb VEGF; Avastin (Trade Name); Recombinant Humanized Anti-VEGF Monoclonal Antibody; VEGF Inhibitor; Monoclonal Antibody hF1; Immunoglobulin G1, anti-(human vascular endothelial growth factor) (human-mouse monoclonal rhuMAb-VEGF γ1-chain), disulfide with human-mouse monoclonal rhuMAb-VEGF light chain, dimer
EINECS	Contact for details

Quality Control

Our Bevacizumab is manufactured and tested under strict quality management systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. A Certificate of Analysis (COA) detailing specifications for purity (by SEC-HPLC and CE-SDS), biological activity (cell-based assay), endotoxin levels, and host cell protein/DNA content is provided with every shipment to guarantee compliance for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at 2-8°C. Reconstituted or liquid formulations should be stored as directed by the specific product monograph, typically at 2-8°C and protected from light. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (SEC-HPLC / CE-SDS)	Conforms to reference standard
Purity (Monomer by SEC-HPLC)	≥ 98.0%
Purity (CE-SDS, Reduced & Non-reduced)	Conforms to reference standard
Protein Content (A280)	95.0 - 105.0% of label claim
Potency (Cell-based Bioassay)	90.0 - 115.0% of reference potency
pH	5.5 - 6.5 (for solution)
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg

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