Pre-Commercial CDMO Services
Experienced in Optimizing Your Molecule's Success
At Cytovance Biologics, our emphasis on manufacturing process characterization, validation, and regulatory support are central pillars of our commitment to patient safety and our dedication to your success. Drawing on the cumulative experience gained with more than 350 APIs in clinical phase evaluation with multiple commercially approved products, we provide valuable input on your long-term design and regulatory strategy to minimize risk, timelines, and costs. We offer process characterization and subsequent process validation services using Quality by Design-based approaches that insulate your molecule from any unexpected roadblocks in the transition between phases of your project.
Partnering with the cross-functional experts at Cytovance ensures procedural and operational excellence with absolute regulatory compliance as your molecule progresses to market.
Life Cycle Management
Our strong regulatory history supports you from the start.
Identification of critical process parameters for a successful scale-up.
Demonstrating process robustness and reproducibility.
Ingenuity, On Demand
Thought Leadership from Team Cytovance
Process Characterization & Statistical Modeling — Transforming Data into Knowledge Throughout the Product Lifecycle
Regulatory Strategies for Gene Therapy Product Development
Phase Appropriate GMPs – A Regulatory Roadmap
The Power of Partnership
“Working with the encouraging and proactive Program Management team at Cytovance is better than the team at our previous CDMO.”
— Program Lead, Medium Biotech