Plasma fractionation issues

Biologicals

Volumn 37, Issue 2, 2009, Pages 88-93

  Farrugia, Albert ^a   Evers, Theo ^b   Falcou, Pierre Francois ^c   Burnouf, Thierry ^d   Amorim, Luiz ^e   Thomas, Sylvia ^f  

^a Office of Devices   (Australia)

^b Europ Plasma Fractionation Assoc   (Netherlands)

^c LFB   (France)

^d HUMAN PROTEIN PROCESS SCIENCES   (France)

^e Hemobras   (Brazil)

^f Brazilian Federation of Hemophilia   (Brazil)

Author keywords

Factor VIII; IVIG; Procurement of plasma; Protein fractionation; Viral inactivation

Indexed keywords

ALBUMIN; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; HEPATITIS B ANTIBODY; IMMUNOGLOBULIN; PLASMA PROTEIN; PLASMA SUBSTITUTE;

ARTICLE; BLOOD DONOR; BLOOD STORAGE; BRAZIL; COST BENEFIT ANALYSIS; FRACTIONATION; FREEZING; HEMOPHILIA; PLASMA; PRIORITY JOURNAL; RISK ASSESSMENT; SCREENING; VIRUS INACTIVATION;

BLOOD BANKS; BLOOD COMPONENT REMOVAL; BLOOD DONORS; BLOOD SPECIMEN COLLECTION; BRAZIL; HEMOPHILIA A; HUMANS; INFECTION CONTROL; MANDATORY TESTING; PLASMA; QUALITY CONTROL;

HEPATITIS B VIRUS; HEPATITIS C VIRUS;

EID: 63249113806     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.01.005     Document Type: Article

References (15)

1. Burnouf T. Modern plasma fractionation. Transfus Med Rev 21 (2007) 101-117
2. Farrugia A. Plasma for fractionation: safety and quality issues. Haemophilia 10 (2004) 334-340
3. Burnouf T., and Radosevich M. Reducing the risk of infection from plasma products: specific preventative strategies. Blood Rev 14 (2000) 94-110
4. Farrugia A. International movement of plasma and plasma contracting. Dev Biol (Basel) 120 (2005) 85-96
5. CHMP. Guideline on requirements for plasma master file (PMF) certification (2004). CPMP/BWP/4663/03
6. CHMP. Guideline on the scientific data requirements for a plasma master file (PMF) (2004), European Medicine Evaluation Agency. EMEA/CPMP/BWP/3794/03
7. WHO. Recommendations for the production, quality control and regulation of plasma for fractionation (2005).
8. PIC/S GMP guide for blood establishments - PE005-2: pharmaceutical inspection convention (2004)
9. Burnouf T. Plasma fractionation in the world: current status. Transfus Clin Biol 14 (2007) 41-50
10. [accessed 25.08.07].
11. O'Mahony B. Guide to national tenders for the purchase of clotting factor concentrates (2006), World Federation of Hemophilia. Available from:
12. Albert Farrugia. Guide for the assessment of clotting factor concentrates. © World Federation of Hemophilia. PDF file at ; 2003.
13. Comprasnet (for acquisition of goods and services by federal government). .
14. The proceedings of the World Federation of Hemophilia's Fourth Global Forum on the safety and supply of treatments for bleeding disorders (2005), © World Federation of Hemophilia. Available from:
15. Brooker M. Price usage and variation. WFH Fourth Global Forum on the safety and supply of treatment products for bleeding disorders (2005). Available from: