The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables

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...

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Bibliographic Details
Published in:Vox sanguinis 2010-10, Vol.99 (3), p.232-238
Main Authors: Lawrie, A. S., Green, L., Canciani, M. T., Mackie, I. J., Peyvandi, F., Scully, M. A., Machin, S. J.
Format: Article
Language:English
Subjects:
Affinity chromatography
antithrombin
Blood Proteins - analysis
Chromatography, Affinity - methods
Coagulation factors
Detergents
endogenous thrombin potential
fresh-frozen plasma
Hemostatics - analysis
Humans
microparticles
Octaplas
OctaplasLG
Plasma
Plasma - chemistry
Prion protein
prion reduction
Prions
protein C
protein S
Proteinase inhibitors
prothrombin
S/D plasma
Solvents
Thrombin
thrombin generation test
Variables
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Summary: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, VWF:Ag, antithrombin, protein C and free protein S were all > 75 u/dl. ADAMTS‐13 activity levels were normal. Factor VIII and VWF:RCo 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.
ISSN:0042-9007
1423-0410
DOI:10.1111/j.1423-0410.2010.01346.x