What Is Latanoprostene Bunod Ophthalmic?
Latanoprostene bunod is a nitric oxide (NO)-donating prostaglandin F2α analog that is metabolized to two active moieties: latanoprost acid (a prostaglandin analog) and butanediol mononitrate (which releases NO). This dual mechanism reduces IOP by increasing both uveoscleral outflow through the prostaglandin pathway and trabecular meshwork outflow through NO-mediated relaxation of trabecular meshwork and Schlemm's canal cells. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Latanoprostene Bunod Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Latanoprostene Bunod 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
- Nitric oxide-donating prodrug stability requiring inert atmosphere processing
- Dual metabolite formation validation and pharmacokinetic characterization
- Low-concentration formulation with two active degradation pathways
- Temperature-sensitive storage and cold chain distribution requirements
- Light-protected packaging with oxygen-barrier container closure systems
- Complex impurity profiling for both prostaglandin and NO-donor moieties
💡 Why Latanoprostene Bunod Ophthalmic Is a Valuable Technology Transfer Opportunity
As the first NO-donating prostaglandin, latanoprostene bunod offers differentiated efficacy over traditional prostaglandin analogs by targeting the trabecular meshwork pathway. This novel mechanism addresses the primary site of outflow resistance in glaucoma, providing a compelling technology transfer opportunity.
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
Latanoprostene Bunod 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.