What Is Faricimab Ophthalmic?
Faricimab is the first bispecific antibody approved for ophthalmic use. It simultaneously binds and neutralizes both VEGF-A and angiopoietin-2 (Ang-2), addressing two distinct pathways involved in retinal vascular disease. By inhibiting both targets, faricimab offers potentially longer treatment intervals compared to single-target anti-VEGF therapies, reducing treatment burden for patients with wet AMD and DME. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Faricimab Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Faricimab 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
- Bispecific antibody expression requiring specialized cell line engineering
- Dual-target binding validation and potency assay development
- Complex protein purification with multiple chromatography steps
- Formulation stability for extended shelf life at controlled temperatures
- Sterile fill-finish for intravitreal injection at precise volumes
- Comparability and biosimilarity assessment for two distinct binding domains
💡 Why Faricimab Ophthalmic Is a Valuable Technology Transfer Opportunity
As the newest entrant in the anti-VEGF ophthalmic market, faricimab represents a significant advancement with its bispecific mechanism. The extended dosing interval potential creates strong market differentiation, and early technology transfer positioning allows manufacturers to capture growing demand as the molecule gains global adoption.
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
Faricimab 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.