What Is Ranibizumab Ophthalmic?
Ranibizumab is a humanized monoclonal antibody Fab fragment that binds and inhibits all active forms of VEGF-A. Unlike full-length antibodies, the smaller Fab fragment (48 kDa) allows better retinal penetration after intravitreal injection. It was the first anti-VEGF agent specifically developed for intraocular use and has extensive clinical data supporting its efficacy in wet AMD, DME, diabetic retinopathy, and macular edema secondary to retinal vein occlusion. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Ranibizumab Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Ranibizumab Ophthalmic manufacturing requires GMP-compliant facilities with ophthalmic-grade cleanroom capabilities. The formulation process involves precise compounding, sterile filtration or aseptic processing, and quality control testing to ensure release specifications are met for intraocular or topical ophthalmic administration.
Key Manufacturing Challenges
- E. coli expression system with inclusion body refolding process
- Fab fragment purification requiring specific chromatography strategies
- Protein aggregation control in concentrated ophthalmic formulations
- Sterile manufacturing with endotoxin levels critical for intraocular use
- Stability maintenance of antibody fragment conformation
- Precise fill volume and container closure integrity for single-use vials
💡 Why Ranibizumab Ophthalmic Is a Valuable Technology Transfer Opportunity
Multiple ranibizumab biosimilars have been approved globally, validating the regulatory pathway. The established clinical evidence base and physician familiarity make it an ideal technology transfer candidate, with strong demand in markets transitioning to local biologics production.
What Is Included in the Technology Transfer Package
Master Batch Formula
Complete formula with API and excipient quantities, equipment specifications, and step-by-step manufacturing instructions with process flow charts.
Manufacturing Process
Detailed process description with critical process parameters, in-process controls, and validated acceptable ranges for scale-up.
Stability Data
Accelerated and long-term stability results under ICH conditions with degradation analysis and shelf-life projections.
CTD/eCTD Dossier
Pre-formatted regulatory templates for FDA, EMA, Health Canada, TGA, and PMDA submissions — ICH and PIC/S compliant.
Analytical Methods
Validated procedures for assay, impurity profiling, sterility, particulate matter, osmolality, pH, and complete release testing.
Expert Consultation
Direct access to Burrard's ophthalmic formulation scientists and regulatory specialists for hands-on technical guidance.
Regulatory Pathway
Burrard Pharmaceuticals provides CTD/eCTD dossier templates pre-formatted for submissions to FDA, EMA, Health Canada, TGA, and PMDA. All documentation complies with ICH guidelines and PIC/S standards. Our regulatory team can help adapt documentation for additional national authorities in your target markets.
Target Markets
Ranibizumab Ophthalmic technology transfer is particularly suited for pharmaceutical manufacturers in regions with growing ophthalmic care infrastructure: Eastern Europe, Middle East, CIS countries, Latin America, Southeast Asia, and Africa — markets with increasing demand for affordable, locally produced ophthalmic treatments.
Why Choose Burrard Pharmaceuticals
- Established since 2005: Nearly two decades of CDMO experience from Vancouver, Canada.
- GMP-compliant know-how: All documentation meets FDA, EMA, Health Canada, TGA, PMDA, PIC/S, and WHO GMP standards.
- Complete integrated package: Master formula through regulatory dossier in one delivery.
- Fast delivery: 2–21 business days via our secure digital portal.
- Ongoing support: Expert consultation hours included, plus 24/7 technical support after transfer.
- 70+ molecule portfolio: Cross-therapeutic expertise from oncology to ophthalmics.