The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables.
Vox Sang
; 99(3): 232-8, 2010 Oct.
Article
in En
| MEDLINE
| ID: mdl-20840338
ABSTRACT
BACKGROUND:
Octapharma PPGmbH has recently modified its manufacturing process for solvent/detergent-treated plasma to incorporate a prion reduction step, in which a 3 log reduction has been demonstrated. The current study was undertaken to assess the impact of this procedure on haemostatic variables in the new product OctaplasLG in comparison with standard Octaplas.METHODS:
Production batches of standard Octaplas (n=4) and OctaplasLG (n=16) were assessed for levels of coagulation factors, physiological protease inhibitors, markers of activation and procoagulant microparticles. Global haemostasis was assessed by a thrombin generation test (TGT) and rotational thromboelastometry (ROTEM).RESULTS:
Mean levels of factors II, V, VII, IX, X, XI, XII and XIII, VWFAg, antithrombin, protein C and free protein S were all >75 u/dl. ADAMTS-13 activity levels were normal. Factor VIII and VWFRCo were >55 u/dl. TGT and ROTEM were similar in both preparations, and microparticles were present at negligible levels. Two units of OctaplasLG had slightly elevated levels of Prothrombin Fragments 1+2, but D-Dimer and thrombin-antithrombin complexes were normal in all batches.CONCLUSION:
These studies indicate that the affinity chromatography procedure used in OctaplasLG does not appear to adversely affect the proven haemostatic quality of Octaplas, while offering a selective reduction in the concentration of pathological prion proteins.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Plasma
/
Prions
/
Hemostatics
/
Blood Proteins
Limits:
Humans
Language:
En
Journal:
Vox Sang
Year:
2010
Document type:
Article
Affiliation country:
United kingdom