Biosimilar

Bevacizumab Biosimilar Pipeline Development Service

Comprehensive Solutions for VEGF-A-Targeted Biosimilar Development

Creative Biolabs delivers complete Bevacizumab biosimilar development solutions, supporting clients through every stage from molecular characterization to market authorization. Our team's deep expertise in monoclonal antibody engineering and VEGF pathway modulation enables the creation of high-quality biosimilars with scientifically validated therapeutic equivalence. We employ a streamlined development process incorporating cutting-edge analytical methods and optimized manufacturing protocols. Our regulatory specialists provide strategic guidance to efficiently navigate global approval pathways, helping overcome technical and compliance challenges. By combining innovative technologies with proven methodologies, we accelerate development timelines while ensuring robust data packages that meet international standards, ultimately facilitating faster patient access to affordable cancer treatments worldwide.

At a glance of Bevacizumab

Service Overview

Bevacizumab is a humanized monoclonal antibody that selectively binds to vascular endothelial growth factor (VEGF), a critical mediator of angiogenesis. By neutralizing VEGF-A, it inhibits the formation of new blood vessels, thereby starving tumors of oxygen and nutrients. This anti-angiogenic mechanism has proven effective in treating various cancers, including metastatic colorectal, lung, and ovarian cancers, often combined with chemotherapy. Additionally, it's used in ophthalmology for neovascular age-related macular degeneration. While generally well-tolerated, potential adverse effects include hypertension, bleeding, and impaired wound healing. As a pioneering anti-angiogenic therapy, bevacizumab has paved the way for biosimilar development and requiring rigorous analytical. Ongoing research explores its potential in other VEGF-driven pathologies and optimized dosing strategies.

Basic Information

Drug Type: Monoclonal antibody

Synonyms: Bevacizumab(Genetical Recombination); rhuMAb-VEGF; Bevacizumab

Target: VEGF-A

Action: Inhibitors

Mechanism: VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors); Angiogenesis inhibitors

Inactive Indication: Acidemia, Isovaleric; Acute Basophilic Leukemia; Acute Eosinophilic Leukemia

Originator Organization: Genentech, Inc.

Inactive Organization: Roswell Park Comprehensive Cancer Center; The University of California, San Francisco; Celgene Corp.

First Approval Date: United States (26 Feb 2004)

Most Recent Events

Date	Events
28 JUL 2025	IMFINZI® (durvalumab ) granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers
28 JUL 2025	Imfinzi granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers

Pipeline Status

Our Bevacizumab Biosimilar Pipeline Offers

Fig.1 Bevacizumab Biosimilar Pipeline. (Creative Biolabs Original)

Development Workflow of Bevacizumab Biosimilar Pipeline

Early Development & Analytical Characterization
1	Reference Product Characterization	Comprehensive Analytical Profiling: Primary structure (LC-MS peptide mapping, N-glycan analysis) Higher-order structure (CD, FTIR, HDX-MS for conformational integrity) Functional attributes (VEGF-A binding kinetics via SPR, anti-angiogenic activity in HUVEC assays)
2	Cell Line Engineering & Upstream Process	High-Producing CHO Clone Development: Targeted integration of bevacizumab light/heavy chains using CRISPR-Cas9 Microscale bioreactor screening for optimal productivity Perfusion Process Optimization: Continuous culture with cell retention technologies Metabolite control via Raman spectroscopy-based feeding
3	Downstream Innovation	Novel Purification Strategies: Mixed-mode chromatography for acidic variant removal Affinity ligand alternatives to Protein A (e.g., Fc-mimetic resins) Viral Clearance Validation: Modular parvovirus filtration (20nm) + low pH hold
Non-Clinical Development
4	In Vitro Functional Characterization Testing	Target Binding & Neutralization: VEGF-A binding affinity (SPR/BLI) with ≤1.5-fold difference vs. reference Inhibition of VEGF-induced HUVEC proliferation (EC50 comparison) Fc Functionality: FcγRIIIa binding (ADCC reporter assay) Complement C1q binding (ELISA)
5	In Vivo Pharmacology	Pharmacodynamic Models: Matrigel plug assay (murine angiogenesis inhibition) Patient-derived xenograft (PDX) tumor growth suppression Toxicology: 4-week repeat-dose GLP study in cynomolgus monkeys Reproductive toxicity waiver justification via VEGF pathway conservation

Available Packages

Creative Biolabs offers flexible service packages for Bevacizumab biosimilar development. Choose our predefined modules or work with our experts to create a solution tailored to your specific goals and timelines.

NO.	Item Name	Includes	Deliverables
1	Analytical Characterization & Lead Selection	High-titer transient expression (HEK293/CHO) Multi-attribute analysis (HPLC-MS, icIEF, DLS) Target binding affinity (SPR/BLI) FcγRIIIa engagement (ADCC reporter assay)	Lead candidate report Glycosylation profile Stability study datasets
2	Cell Line & Process Development	Stable CHO pool generation (CRISPR-edited) Perfusion process optimization Scale-down model qualification Viral clearance validation	Master Cell Bank (MCB) Process performance qualification (PPQ) protocol Resin lifetime data
3	Preclinical Support	In vitro studies In vivo efficacy (PDX tumor model)	Non-Clinical Data

Why Choose Us

Unmatched Technical Excellence

Cutting-Edge Characterization: Our high-resolution analytics platform delivers 360° molecular profiling beyond standard compendial methods.

Functional Relevance

Client-Centric Flexibility

Phase-Appropriate Engagement: From standalone analytical services to fully integrated development - pay only for what you need.

Ready to Advance Your Bevacizumab Biosimilar Program

Contact us to architect a biosimilar-specific strategy—whether you need cost benchmarking, scientific advisory sessions, or detailed service catalogs.

For research use only. Not intended for any clinical use.

Send Inquiry

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.