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Unused Plasma Plasma Fractions Thierry Burnouf HPPS, Lille, France

WHF Forum 2005. Topic

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Unused Plasma Plasma Fractions Thierry Burnouf HPPS, Lille, France

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    1. WHF Forum 2005 Unused Plasma & Plasma Fractions Thierry Burnouf HPPS, Lille, France

    2. WHF Forum 2005 Topic & questions WFH encourages plasma collectors and fractionators to find ways to exploit plasma or plasma fractions that are currently being unused Questions: How much? Which ones? Limiting factors?

    3. WHF Forum 2005 Unused plasma?

    4. WHF Forum 2005 Availability of plasma from whole blood ? ~ 80 M whole blood collections worldwide* Theoretical volume plasma: ~ 16 M L / year * GDBS, WHO, 1999

    5. WHF Forum 2005 Use of plasma from whole blood ~ 3 M L plasma for transfusion (FFP) ~ 13 M L theoretically available for fractionation ~ 50% fractionated, mostly in developed countries A potential of ~ 50% not fractionated

    6. WHF Forum 2005 Plasma « unused » for fractionation Fragmented collection centers in developing countries: Lack of coordinated national blood transfusion system Small quantity / center Large % of family / replacement donors Quality criteria for plasma for fractionation not met NRA still lacks direct hands-on experience on regulation of plasma and plasma products

    7. WHF Forum 2005 Unused fractions ?

    8. WHF Forum 2005 Unused industrial cryoprecipitate? Developed countries: Cryo used directly by fractionator or sold to another producer Essentially no cryo available in developed countries (except Canada)

    9. WHF Forum 2005 Situation in China Driving protein is albumin Most plasma not used to make FVIII or FIX Production of Factor VIII from ~ 10% of the total volume of plasma Cryo from ~ 4.5 M L not exploited

    10. WHF Forum 2005 Factor IX / PCC Made from cryo-poor plasma Less clinical needs than FVIII Recovery twice that of FVIII Cryo-poor plasma and Factor IX intermediates are liquid: difficult to transport

    11. WHF Forum 2005 Examples of factors making difficult the use of plasma and plasma intermediates

    12. WHF Forum 2005 Quality and regulatory issues Plasma or intermediates do not meet quality criteria (e.g. testing, freezing, or storage conditions, etc) of the fractionator and/or NRA Significant regulatory work needed to qualify plasma or intermediates as a source of medicinal products

    13. WHF Forum 2005 Cost and Quantity issues Cost and quantity of source materials + manufacturing cost must allow return on sales and economy of scale justifying efforts on: Ensuring compliance of the starting plasma and/or intermediates Regulatory work to license end-products

    14. WHF Forum 2005 Legal issues National laws/regulations may prohibit export of human plasma material

    15. WHF Forum 2005 Liability issues Liability for product side-effects including pathogens transmission: Plasma? Manufacturing process? Clinical use?

    16. WHF Forum 2005 Capacity (developed countries) Lack of capacity to handle plasma; potential production « bottle-necks » Less issues for cryoprecipitate than for plasma

    17. WHF Forum 2005 Equipment (other countries) No equipment for cold plasma thawing and cryoprecipitation No freeze-drying capacity

    18. WHF Forum 2005 Technology Technology license agreements between fractionators may prohibit its use for export market or contract fractionation activities

    19. WHF Forum 2005 Conclusion Availability: Unused recovered plasma available in developing countries Unused cryo Marginal quantity in developed countries Potentially available in other countries

    20. WHF Forum 2005 Conclusion Issues (developing countries): Quality standards of plasma/fractions for fractionation are not met Plasma collection practices not harmonized at national level Build-up technical expertise of local NRA and of local plasma producer

    21. WHF Forum 2005 Dr. D. Armstrong, South-Africa Dr. M. El-Ekiaby, Egypt Mr. T. Evers, IPFA Mr. D. Murphy and Mr. M. Crowley, USA Dr. A Padilla, WHO Mr. C. Waller, PPTA Dr. F-L Zhou, China

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