Your Contract Development Manufacturing Operation Expert
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1. Process & Analytical Development
• Technology & Innovation
• DOE & QBD
• DOE & QBD
2. Scale-up and Clinical Supply
• HSE Support
• Program Management
• Program Management
3. Industrial Validation
• Process and Analytical Validation
• Supply-Chain Security
• Supply-Chain Security
4. Commercial Supply
• Continuous Process Improvement
• Lyfecycle Management
• Lyfecycle Management
5. Full CMC Regulatory Support
• Registrations in over 60 countries
• Paper or electronic submissions
• Paper or electronic submissions
With a long-term expertise in the development and industrial scale manufacturing of APIs, Cerbios is the ideal partner from clinical to commercial supply
HPAPIs
• Safebridge category 3 & 4
• OEL < 30ng/m3
• From few grams to 35kg/batch
• OEL < 30ng/m3
• From few grams to 35kg/batch
ADCs
• Monoclonal Antibody
• Payload (cytotoxic and not)
• Conjugation
• Payload (cytotoxic and not)
• Conjugation
Proteins & Antibodies
• Early Stage
• Master cell banks
• Clinical Batches
• Master cell banks
• Clinical Batches
Live Biotherapeutics
• Fermentation
• Drying
• Stabilization
• Drying
• Stabilization
