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GTP Scenario # 1. September 17,2005. Scenario # 1. J Smith is 10 months old with leukemia in remission. He is scheduled to receive a PBPC transplant from HLA matched, ABO major incompatible sibling . Product has excessive RBCs and CD34 + cells. Lab is to:

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Gtp scenario 1

GTP Scenario # 1

September 17,2005


Scenario 1
Scenario # 1

  • J Smith is 10 months old with leukemia in remission. He is scheduled to receive a PBPC transplant from HLA matched, ABO major incompatible sibling.

  • Product has excessive RBCs and CD34+ cells.

  • Lab is to:

    • Perform a density gradient separation in 50 ml conical tubes.

    • Freeze ‘excess’ cells.


Laboratory information
Laboratory Information

  • Cell Therapy Laboratory:

    • Unclassified facility.

    • BSC cleaned with an appropriate cleaning agent before use (1 product per BSC).

    • BSC is certified annually.

    • Centrifuge cleaned as part of preventive maintenance (not before use).

  • What level of EM and Cleaning is required?


What should be considered
What should be considered?

  • Evaluate the conditions.

    • The process is ‘open’.

    • The product is a 361 GTP product.

    • The laboratory is an unclassified room.

    • Cell manipulations occur in the BSC.


Product monitoring
Product Monitoring

  • Sterility: Pre & Post processing?

    • Recommended

  • Periodic audit review of sterility results?

    • Recommended


Bsc environmental monitoring
BSC Environmental Monitoring

  • Settle plates during processing?

    • Recommend performing as part of process validation. Review data and determine need based on risk assessment.

  • Surface sampling after cleaning?

    • Perform as part of validation and as periodic check of cleaning procedure.

  • Airborne sampling during processing?

    • Only perform if settle plate data inconclusive or trending upward.


Facility monitoring
Facility Monitoring

  • Perform air particle counts during processing?

    • Recommend periodic checks during laboratory ‘working hours’ (dynamic monitoring).


Centrifuge monitoring
Centrifuge Monitoring

  • Perform EM sampling of the surfaces (buckets)?

    • Recommend performing as part of process validation.

    • Recommend performing after preventive maintenance.

    • Recommend performing during processing only if products begin to have positive sterility results.


Personnel monitoring
Personnel Monitoring

  • Perform on day of processing after the staff completes the process?

    • Recommend performing as part of process validation and/or employee training.

    • Recommend performing during processing only if products begin to have positive sterility results.


Em pm result review
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).


Cleaning
Cleaning

  • BSC?

  • Centrifuge?

  • Lab benchtops?

  • Lab floors?

  • Control rate freezer?

  • Document Review?


Cleaning recommendations
Cleaning Recommendations

  • BSC: Clean before & after use with an appropriate cleaning agent.

    • Unless validation EM/PM results indicate this is not adequate.

    • Unless post-processing cultures become positive (investigation outcome).

    • Unless there is a spill.


Cleaning recommendations1
Cleaning Recommendations

  • Centrifuge & Benchtops:

    • Clean before & after use with appropriate cleaning agent.

  • Control Rate Freezer:

    • Clean on a periodic basis as per manufacturer’s instructions.

  • Floors:

    • Clean on a periodic basis.

  • Unless validation EM/PM results indicate this is not adequate.

  • Unless post-processing cultures become positive (investigation outcome).

  • Unless there is a spill.


Cleaning document review
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.


Variation
Variation

  • Would you do anything differently if the donor were HCV positive?

    • Consider whether cleaning agent in use is viricidal


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