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In this section: Center for Drug Evaluation and Research (CDER)

Examples of Accepted Emerging Technologies

Emerging technologies for small molecules

Continuous manufacturing of drug substance
Continuous manufacturing of drug product
Model-based control strategy for continuous manufacturing
Continuous aseptic spray drying
3D printing manufacturing
Ultra-long-acting oral formulation

Emerging technologies for biological molecules

Controlled ice nucleation for lyophilization processes
Advanced process control such as predictive modeling for process monitoring and closed loop bioreactor control
Multi-attribute method
Next generation sequencing
Continuous manufacturing for downstream processes
Pharmacy on demand (a small manufacturing platform for continuous bioprocesses)

Emerging technologies for multiple products

Closed aseptic filling system
Isolator and robotic arm for aseptic filling
Novel container and closure systems for injectable products

Emerging Technology Program Main Page

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