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Advanced Cell Therapies - GMP Manufacturing

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Advanced Cell Therapies
Challenges and Solutions
for GMP manufacturing
Topics
Advanced Cell Therapies:
Trends and Challenges
Manufacturing Options:
Isolator or Clean Room?
Comecer Isolation Tec...
Trends and Challenges
Advanced Cell Therapies

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Advanced Cell Therapies - GMP Manufacturing

  1. 1. Advanced Cell Therapies Challenges and Solutions for GMP manufacturing
  2. 2. Topics Advanced Cell Therapies: Trends and Challenges Manufacturing Options: Isolator or Clean Room? Comecer Isolation Technology
  3. 3. Trends and Challenges Advanced Cell Therapies
  4. 4. ACT Trends
  5. 5. ACT Challenges Compliance Safety Reproducibility Effectiveness
  6. 6. ACT Challenges Compliance GMP Guidelines Directive 2003/94/EC Safety Risk Elimination Sterility assurance Cross- contamination avoidance Reproducibility Minimize operator tasks Eliminate unexpected situations Reduce workload Effectiveness Easy scalability
  7. 7. Manufacturing Options Advanced Cell Therapies
  8. 8. Isolator or Clean Room?
  9. 9. Isolation Technology is well known in pharmaceutical industry • To manage HAPI (Highly Active Pharmaceutical Ingredients) • To test batch sterility in pharma preparations • To aseptically dispense ingredients among different preparations • To aseptically prepare non sterilizable formulations • To conduct Research & Development
  10. 10. Isolation Technology is a path from user requirements to validation UNDERSTAND SHARE SKETCH DISCUSS GENERAL DESIGN DISCUSS DETAILED DESIGN DISCUSS MANUFACTURE FAT INSTALL SAT – IQ/OQ
  11. 11. Asepsis and containment can coexist with isolation technology ASEPSIS: protect product from operator’s environment • Physical and Aerodynamic Barrier (positive pressure) • Clean ability • Special attention to critical areas • Powerful Decontamination • Environmental Monitoring for Class A CONTAINMENT: protect operator from product • Physical and Aerodynamic Barrier (negative pressure) • Clean ability • Precautions for filter replacements • Powder handling • Explosion proof
  12. 12. Layout differences Isolator: all-in-one approach Clean Room: cascade approach
  13. 13. Space occupancy Isolator • Lower footprint • Less classified area • Lower investment per square meter of classified area • No airlocks Clean Room • Higher footprint and space requirement • Larger classified area • High investment per square meter of classified area • Needs airlocks
  14. 14. Time management Isolator • Fast access • Faster personnel • Modularity provides higher throughput Clean Room • Slow access • Slower personnel • Fixed configuration gives lower throughput
  15. 15. Control Management Isolator • Easy validation given small space • Easy microbio control • Reduced number of SOP and training needs Clean Room • Complex validation of large and different spaces • Complex microbio control • Huge SOP and training needs
  16. 16. Sanitization management Isolator • One product strategy: H2O2 vapour sterilization • Easy pass-through sterilization with H2O2 • Largely automated process Clean Room • Complex cleaning procedures for A and B areas • Uses many products • Fully manual process
  17. 17. Operational costs of an isolator are significantly lower than a clean room
  18. 18. Running costs of an isolator are one-third of those of a clean room 0 10000 20000 30000 Gowning Micro Bio Control Sanitization Electricity Hepa Filters Gloves Validation Isolator Clean Room (Cost estimates expressed in Euro)
  19. 19. Isolation technology is mentioned in GMP Annex I, 21 “The utilization of isolator technology to minimize human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products.”
  20. 20. Our isolation technology
  21. 21. ACT manufacturing with a Comecer Isolator Custom design Flexibility Incubator Lab in a box
  22. 22. Custom design
  23. 23. Flexible configurations 2, 3 and 4 glove modules
  24. 24. Flexible combinations
  25. 25. An incubator module in grade A environment Entire volume (up to 400 l) accessible from the interior of the isolator through 8 small doors. Each door contains two extractable trays.
  26. 26. “Lab in a box” Storage Refrigerator Microscope Centrifuge Transfer Hatch Viable & Non-Viable Monitoring
  27. 27. Integration of all critical areas under isolation technology for ACT Acceptable Convenient Beneficial to procedure Cost effective
  28. 28. A revolution for GMP manufacturing Isolators can be installed in a class D environment, while being validated internally as Class A. This fundamental ability is what primarily constitutes the revolution of this technology compared to the classical clean room approach.

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