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ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
ISPE-KC [October 2011]
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ISPE-KC [October 2011]

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  • 1. ®cGMP, cGTP Facility Design for Production of Human Cells, Tissues and Tissue based products Presented by Kris Chatrathi atInternational Society for Pharmaceutical Engineering-Midwest Chapter October 11, 2011 www.burnsmcd.com/pharma
  • 2. ® Introduction• Regenerative Therapies Overview• FDA, cGMP, CGTP• Facility Introduction• CFD Evaluation of Room• Architectural Alternatives• HVAC Design
  • 3. ® Regenerative Therapies• Repair, replace, restore, regenerate damaged or diseased cells, tissues and organs: – Heart Muscle – Skin for Burn Victims – Spinal Cord Injury – Pancreatic Tissue to Produce Insulin• Cell therapy, tissue engineering, biomaterials engineering, growth factors and transplantation science
  • 4. ® Artificial Vessels• Typically used for by-pass operations
  • 5. ® Artificial Skin for Ulcers and Burns
  • 6. ® Replacement Cartilage• Mimics usual cartilage environment – Cartilage cells – Collagenous scaffold The close up image of cells in the replacement cartilage
  • 7. ® Engineering Bone Grafts• Change stem cells into bone cells – with proper growth factors in cell culture media A 3D calcium phosphate scaffold From Becton Dickinson
  • 8. ® Replacement Cells for DiabetesIn vivo Islet of Langerhans in Pancreas
  • 9. ® A New Bladder To make a bladder a scaffold, along with several different types of cells, are needed.
  • 10. Transplants That Match the Patient ®1. Remove cells from patient.2. Grow in culture with or without biomaterials.3. Give appropriate chemicals to make cells do what is needed.4. Replace into patient.
  • 11. ® FDA• CBER (Center for Biologics Evaluation and Research): vaccines, blood and blood products, human tissue/tissue products for transplantation, cell therapy, gene therapy, donor screening tests for blood and tissue safety, devices – Office of Cellular, Tissue and Gene Therapies• Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps)
  • 12. ® cGMP• Ensure Products are Manufactured by a Controlled Auditable Process• cGMP elements – Facilities and Equipment – Personnel and Training – Documentation and Validation – SOP and Error Management – Process Control – Labeling – Auditing
  • 13. ® cGMP/cGTP Focus• Guidance recommendations are focused on preventing infectious disease contamination and cross contamination (including mix-ups) during manufacture• Prevention of the introduction, transmission, or spread of communicable diseases• Evaluate the type of area that a task would require in order to prevent contamination or cross- contamination• Procedures must be established and maintained to prevent contamination or cross-contamination
  • 14. ® Facility User Requirement Specification• Scope• Facility and Process Description• User Requirements: – Barriers, physical barriers to ensure particulate and microbial level do not exceed defined limits – Construction, floors, walls, ceilings and finishes – Atmosphere, requirements for the monitoring and control in classified areas – Processing Equipment – Auxiliary Services – Material Handling and Storage Requirements – Laboratory Functional Requirements
  • 15. ® CFD Objectives• Objective of Baseline Analyses – Simulate flow in lab room – Examine flow environment near bio safety cabinets • Understand impact of installation of cabinet near returns • Determine if room air flows onto interior work surface
  • 16. ® CFD Scope•Scope of Baseline Analysis -Build room and cabinets using supplied data -Define model constraints and parameters •Supply and return flows from TAB report •Balance of airflow exits through gaps around doors -Run cabinet characterization simulation -Run full lab room simulation
  • 17. ® CFD Results• Results – Flow travels from supplies to returns; little mixing occurs – Exhaust flow at cabinet is significant relative to supplies – Air stagnates along wall opposite the returns – Location of cabinet near return creates bias at air curtain • ISO-7 room air extends into cabinet on upstream side • ISO-7 air region extends 19.7 inches into cabinet • Peak air speed at curtain is 80 FPM at center of cabinet (20% reduction) – Increasing air changes/hr will likely increase bias at air curtain
  • 18. ® CFD Results Continued• Other Considerations/Recommendations – Air passing by the cabinets has already passed over the incubators, tables, and occupants – Very low air velocities near the incubators and along the wall opposite the returns could likely be improved • Create an array of overhead diffusers and install returns around perimeter
  • 19. ® Contaminant Study – ComparisonBio Safety Cabinet in Standard Room Bio Safety Cabinet in Lab Room Room air extends 6.9” from Room air extends 19.7” from front of unit @ 4” from sidewall front of unit @ 4” from sidewall
  • 20. ® ConclusionKris Chatrathikchatrathi@burnsmcd.com816-349-6731 AcknowledgementsDavid Leever, Burns & McDonnellDavid Findlay, Burns & McDonnell

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