What Is Bimatoprost Ophthalmic?
Bimatoprost is a synthetic prostamide analog structurally related to prostaglandin F2α. It reduces intraocular pressure (IOP) by increasing both uveoscleral and trabecular outflow of aqueous humor. Unlike traditional prostaglandin analogs, bimatoprost works as a prostamide rather than a free-acid prodrug, providing a distinct pharmacological profile. The 0.01% formulation with increased BAK concentration provides equivalent efficacy to 0.03% with improved tolerability. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Bimatoprost Ophthalmic manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Bimatoprost 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
- Ultra-low concentration formulation (0.01%) requiring precise analytical quantification
- Preservative system optimization (BAK concentration affects both efficacy and tolerability)
- Chemical stability of prostamide structure against oxidation and isomerization
- Container-closure adsorption studies for low-dose ophthalmic formulations
- Sterile manufacturing with validated filtration for viscous solutions
- Multi-dose packaging with antimicrobial effectiveness testing
💡 Why Bimatoprost Ophthalmic Is a Valuable Technology Transfer Opportunity
Glaucoma affects over 80 million people worldwide and is the leading cause of irreversible blindness. Prostaglandin analogs including bimatoprost are first-line therapy, with strong and growing demand for affordable generics particularly in developing markets with limited access to ophthalmic care.
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
Bimatoprost 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.