200 likes | 548 Views
WHF Forum 2005. Topic
E N D
1. WHF Forum 2005 Unused Plasma & Plasma Fractions Thierry BurnoufHPPS, 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