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GTP Scenario # 2

GTP Scenario # 2. September 17,2005. Scenario # 2. Dr. Good received IND approval for CD8 depletion of allogeneic PBMC for a Phase I/II clinical trial. Laboratory Information. Cell Therapy Laboratory: Unclassified facility. BSC cleaned with 10% bleach before use (1 product per BSC).

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GTP Scenario # 2

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  1. GTP Scenario # 2 September 17,2005

  2. Scenario # 2 • Dr. Good received IND approval for CD8 depletion of allogeneic PBMC for a Phase I/II clinical trial.

  3. Laboratory Information • Cell Therapy Laboratory: • Unclassified facility. • BSC cleaned with 10% bleach before use (1 product per BSC). • BSC is certified annually. • Depletion is performed in the general laboratory area (not within BSC). • Product sampling is performed in the BSC. • What level of EM and Cleaning is required?

  4. What should be considered? • Evaluate the conditions. • The process is ‘functionally closed’. • The product is a 351 IND product. • The laboratory in which the depletion process occurs is an unclassified room. • Other processing (sampling, antibody addition) occurs in the BSC.

  5. Product Monitoring • Sterility: Pre & Post processing? • Recommended • Periodic audit review of sterility results? • Recommended

  6. BSC Environmental Monitoring • Settle plates during processing? • Recommend as part of process validation. Determine need based on data. • Surface sampling after cleaning? • Perform as part of validation and as periodic check of cleaning procedure. • Airborne sampling during processing? • Not recommended.

  7. Facility Monitoring • Perform air particle counts during processing? • Recommend monthly checks during laboratory ‘working hours’ (dynamic monitoring).

  8. Personnel Monitoring • Perform on day of processing after the staff completes the process? • Recommend performing during processing only if products begin to have positive sterility results.

  9. EM & PM Result Review • How often? • Recommend monthly review. • Does this need to be done before product release? • Review cannot be part of product release; the product is infused immediately after processing (fresh).

  10. Cleaning • BSC? • Depletion Device? • Lab benchtops? • Lab floors? • Document Review?

  11. Cleaning Recommendations • BSC • Cleaning with 10% bleach before & after use. • Unless post-processing cultures become positive (investigation outcome).

  12. Cleaning Recommendations • Depletion Device & Benchtops: • Clean before & after use; Device using manufacturer’s instructions, Benchtop using 70% IPA. • Floors: • Clean on a periodic basis. • Unless post-processing cultures become positive (investigation outcome). • Unless there is a spill.

  13. Cleaning Document Review • How often? • Recommend periodic document review. • Does this need to be done before product release? • Review should not be part of product release.

  14. Variation # 1 • Would you do anything differently if the blood had to be ficolled in conical tubes before depletion? • Yes, refer to ‘open’ process recommendations.

  15. Variation # 2 • Would you change anything if this were a Phase III study? • No, unless required by the FDA.

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