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Dr Mark W Lowdell Director Paul O’Gorman Laboratory of Cellular Therapeutics

Environmental conditions for the processing and storage of haemopoeitic progenitor cells – past and present. Dr Mark W Lowdell Director Paul O’Gorman Laboratory of Cellular Therapeutics Royal Free & University College Medical School. History of HSCT & Cell Therapy.

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Dr Mark W Lowdell Director Paul O’Gorman Laboratory of Cellular Therapeutics

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  1. Environmental conditions for the processing and storage of haemopoeitic progenitor cells – past and present Dr Mark W Lowdell Director Paul O’Gorman Laboratory of Cellular Therapeutics Royal Free & University College Medical School

  2. History of HSCT & Cell Therapy • 1950’s - Experimental animal BMT • 1957 - First safe allogeneic clinical BMT – Ed Donnell Thomas • 1960’s - HLA discovered – TRM reduced from ~100% to ~50% • 1970’s – Establishment of BMT units in Specialist Centres TCD with SRBC – ex-vivo manipulation Autologous BMT – cryopreservation - DMSO • 1980’s - Expansion of BMT & PBSCT First ever use of therapeutic mAbs Purging Bone banks & tissue banks Cellular immunotherapy trials – ex-vivo culture • 1990’s - Rapid expansion of PBSCT FA(H)CT standards • 1997 - “Guidance Notes on the Processing, Storage and Issue of Bone Marrow and Blood Stem Cells”– DoH • 2001 - Tissue Banking CoP – DoH • 2003 - First JACIE standards • 2004 - HTAct • 2006 - EUT&C directive • 2007 - FACT/JACIE combined standards – Worldwide accreditation

  3. Commonly used facilities pre-1997 for processing HPC • Routine category 2 laboratory (often within research department – no filtered air • Processing within class II microbiological safety cabinet • Most (all) procedures “open” • Products cryopreserved in liquid nitrogen • NB – most products BM

  4. Conventional laboratory “Open” processing

  5. Facilities – in response to Guidance Notes 1997 • Dedicated laboratory with restricted access • Processing in “closed” system OR within class II microbiological safety cabinet • Products cryopreserved double-bagged in nitrogen vapour-phase

  6. Dedicated laboratory with restricted access • Specific lab coats • Two-stage entry

  7. “Closed” processing

  8. DoH Code of Practice for Tissue Banks - 2001 • Code of Practice for Tissue Banks 1/4/2003covers: • All human tissues used for therapeutic purposes, including clinical trials (no distinction I / II or III) • Haematopoietic progenitor cells • Donor leucocytes / granulocytes • Autologous cell systems • Excludes • Blood and products subject to other national requirements (NBS) • Tissues for research other than clinical trials • Cells and cell lines used for gene therapy (GTAC) • Commercially manufactured cell products (Medicines Act)

  9. CoP “recommendations” • All products • Good Manufacturing Practice • Good Laboratory Practice • Screening of donors • Hep B/C; HIV-1&2, HIV-1 Ag, HTLV-1, CMV, EBV, HAV, VZV, HSV • Serology for syphilis and toxoplasmosis • Microbial screening of processed products • Cryo storage in nitrogen vapour

  10. Facilities - 2001 • Dedicated Grade B laboratory (minimum 25Pa) with restricted access via a Grade C gowning area (minimum 15Pa) • Monitored 24/7 to confirm environment • Critical response times • Monitored weekly for microbial contaminants • In process • At rest • Monitored 1/4ly for particulates • Processing in “closed” system OR within grade A laminar flow cabinet – Annex 13 GMP • Monitored weekly for microbial contaminants • In process • At rest • All critical equipment monitored for performance

  11. Typical pharmaceutical laminar air flow work station Open aspect No operator protection

  12. Typical Class II microbiological laminar air flow safety cabinet Closed aspect Adequate operator protection

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