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  5. Examples of Accepted Emerging Technologies
  1. 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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