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Permits HOWIE compliant sleeves

Permits HOWIE compliant sleeves. Most Processes are “closed”. Although some transfers are “open”. Unlike traditional “clean rooms”, cell therapy production labs require processing equipment. Processes are often complex and require multiple disposables and hence storage. What does it cost?.

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Permits HOWIE compliant sleeves

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  1. Permits HOWIE compliant sleeves

  2. Most Processes are “closed” Although some transfers are “open”

  3. Unlike traditional “clean rooms”, cell therapy production labs require processing equipment. Processes are often complex and require multiple disposables and hence storage.

  4. What does it cost? RECURRENT CAPITAL • Facilities - £800k • Extra staff – • Director (p/t) £15k p/a • QA manager (p/t) £18k p/a • Processing scientist £35k p/a • Additional contracts – • Cleaning £1.5k p/a • Plant monitoring £ 2k p/a • Environmental £ 4k p/a • Equipment calibration £1.2k p/a • Additional disposables – • Hats / overshoes / lab coats £1.9k p/a£78.6k pa £800k

  5. Have these changes reduced microbial contamination of therapeutic cell products? • ALL HPC collections received into RFH Cell Therapy Lab since 1979 have been tested for microbial contamination at receipt. • ALL HPC stored and/or released since 1979 have been tested for microbial contamination post-processing. • In 2003 we moved to grade B processing labs. • In 2006 we audited the effect of this move on incidence of microbial contamination.

  6. Audited workload

  7. 4. Was there any effect on patient outcome?

  8. The current requirements of the EUT&CD 2006/86/EC • “Open” procedures to be undertaken in a grade A environment within a minimum of a grade D background • Individual MS may apply a higher standard • HTA has accepted the directive standard

  9. Hepatitis B transmission from contaminated cryopreservation tankTedder et al Lancet 1995:346:137-40 • 1992-94: Six transplant patients with Hep B infections, five post-transplant, one, (patient “A”) with marrow stored in liquid nitrogen tank from 1992 onwards • All marrow autografts stored in same liquid nitrogen • Aqueous Cryotank “sludge” tested -1ng/ml HBsAg • Identical HBV DNA sequence to patient A in three affected transplant patients available for testing

  10. Gambro “Haemofreeze” bags

  11. Conclusions • Grade B working environment is excessive and oppressive for staff performing complex and prolonged procedures • Much time wasted “in process” monitoring • GMP compliant gowns are not HOWIE compliant • Grade B environment can be achieved without Annex 13 gowning • Adoption of Grade B had no impact on product sterility NOR on clinical outcome • Greatest risk to patient is cross-contamination • EUT&CD standards exceed those of FDA, FACT/JACIE and are adequate.

  12. Acknowledgements • Paul O’Gorman “Children with Leukaemia” • Grant Prentice and his processing staff • Maryam Sekhavat • Fiona O’Brien • Kwok Pang • Ed Samuel • Mihai Vasilcan • Mike Watts

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