What Is Omalizumab?
Omalizumab is a anti-ige monoclonal antibody used for severe allergic asthma. Humanized monoclonal antibody against IgE for severe allergic asthma and chronic urticaria. Burrard Pharmaceuticals offers complete technology transfer know-how packages for Omalizumab manufacturing, including master batch formulas, manufacturing process parameters, stability data, and CTD/eCTD regulatory dossier templates.
Manufacturing Overview
Omalizumab manufacturing requires GMP-compliant facilities with sterile manufacturing capabilities. The formulation process involves precise compounding, pH adjustment, sterile filtration, aseptic filling, and lyophilization to produce stable powder for reconstitution.
Key Manufacturing Challenges
- Sterile manufacturing under aseptic conditions
- Lyophilization cycle optimization for cake quality and reconstitution
- Sterile filtration and aseptic filling validation
- Impurity control and degradation pathway management
- Light and/or moisture sensitivity during manufacturing
- Scale-up from lab to commercial production
💡 Why Omalizumab Is a Valuable Technology Transfer Opportunity
Global demand for severe allergic asthma treatments continues to grow, creating significant market opportunity for manufacturers who can produce quality Omalizumab formulations. Burrard's complete know-how package accelerates your time-to-market by providing proven manufacturing processes, regulatory documentation, and expert support — eliminating years of independent development.
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, dissolution, content uniformity, and complete release testing.
Expert Consultation
Direct access to Burrard's formulation scientists and regulatory specialists for hands-on technical guidance and troubleshooting.
Regulatory Pathway
Burrard Pharmaceuticals provides CTD/eCTD dossier templates pre-formatted for submissions to the United States FDA, European Medicines Agency (EMA), Health Canada, Australia's TGA, and Japan's PMDA. All documentation complies with ICH guidelines and PIC/S standards. Our regulatory consultation can help adapt documentation for additional national authorities in your target markets including ANVISA (Brazil), COFEPRIS (Mexico), NAFDAC (Nigeria), and others.
Target Markets
Omalizumab technology transfer is particularly suited for pharmaceutical manufacturers in regions building local production capacity: Eastern Europe (Poland, Romania, Bulgaria), Middle East (Saudi Arabia, UAE, Iran), CIS countries (Russia, Kazakhstan, Uzbekistan), Latin America (Brazil, Mexico, Argentina), Southeast Asia (Indonesia, Vietnam, Philippines), and Africa (South Africa, Nigeria, Kenya). These markets have growing demand for affordable, locally produced treatments for severe allergic asthma.
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 — no fragmented sourcing.
- Fast delivery: 2–21 business days via our secure digital portal.
- Ongoing support: Expert consultation hours included, plus 24/7 technical support after transfer.
- 60+ molecule portfolio: Cross-therapeutic expertise from oncology to biosimilars.