Drug Product Devlopment

At Glogene, we are committed to advancing global healthcare by delivering biosimilar drug products that match the highest benchmarks of quality, safety, and clinical performance. Our core strength lies in translating scientific rigor into reliable products that expand patient access-without compromising therapeutic integrity.

Our Core Expertise:

• Characterization & Comparability: Advanced analytic and biological testing to confirm similarity in structure, function, and purity
• Thorough Analytical Characterization: Comprehensive physicochemical and biological testing to demonstrate bio similarity in structure, purity, and function
• Regulatory Excellence: Preparing robust, globally aligned documentation packages that streamline regulatory approvals across FDA, EMA, and ICH frameworks
• Rigorous Stability Assurance: Conducting extensive stability studies to guarantee product integrity and shelf life under recommended storage conditions