What Is Aflibercept Ophthalmic?
Aflibercept is a recombinant fusion protein composed of portions of human VEGF receptors 1 and 2 fused to the Fc portion of human IgG1. It acts as a soluble decoy receptor that binds VEGF-A, VEGF-B, and placental growth factor (PlGF) with higher affinity than their native receptors, effectively blocking angiogenesis in retinal neovascular diseases. Approved for wet AMD, DME, macular edema following retinal vein occlusion, and diabetic retinopathy. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Aflibercept Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Aflibercept 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
- Recombinant protein expression and purification requiring CHO cell culture systems
- Strict sterile manufacturing under aseptic conditions for intravitreal injection
- Protein aggregation and degradation control during formulation and storage
- Ultra-precise fill volume control (microliter-scale dosing)
- Cold chain management and light-protected packaging requirements
- Endotoxin control critical for intraocular administration
💡 Why Aflibercept Ophthalmic Is a Valuable Technology Transfer Opportunity
The anti-VEGF ophthalmic biologics market exceeds $15 billion annually, with aflibercept being a market leader. Growing prevalence of diabetic retinopathy and AMD worldwide creates sustained demand for affordable biosimilar alternatives, particularly in emerging markets building local manufacturing capacity.
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
Aflibercept 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.