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

Lawrie, Andrew; Green, Laura; Canciani, Maria Teresa; Mackie, Ian; Peyvandi, Flora; Scully, Marie; Machin, Samuel J.

doi:10.1111/j.1423-0410.2010.01346.x

Cited by 34 publications

(33 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It should be noted that Octaplas in its current form is currently being replaced in several countries by OctaplasLG, a further prion inactivated product with higher concentrations of α2-antiplasmin. 18 We propose that possible disadvantages with Octaplas are well compensated for by pathogen reduction, 3,4 markedly decreased risk of TRALI, 5,6 standardized plasma protein content, 7 and reduced frequency of allergic/ immunologic adverse effects. 6 The incidence of TRALI in Norway is approximately 0.2 cases per 10,000 transfusions.…”

Section: Discussionmentioning

confidence: 99%

Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Haugaa

Taraldsrud

Nyrerød

et al. 2014

Clinical Medicine & Research

View full text Add to dashboard Cite

pathogen inactivation, the SD treatment secures pathogen reduction. [2][3][4] Due to dilution and possible neutralization of the responsible antibodies, SD-plasma has a markedly lower rate of allergic/immunologic reactions including no reported cases of transfusion related acute lung injury (TRALI) despite over 10 million units transfused. 5,6 Further, SD-plasma can be regarded as a biopharmaceutical product with Si gnificant perioperative bleeding and transfusions of plasma, red blood cells (RBCs), and platelets are considered part of the normal clinical course of orthotopic liver transplantation (OLT).1 By far the two most common plasma products available today are fresh frozen plasma (FFP) from single blood donors and solvent/detergent (SD)-treated pooled plasma. Whereas FFP does not undergo any kind of Background: Liver transplantation regularly requires transfusion of red blood cells (RBCs), plasma, and platelets. Compared to fresh frozen plasma (FFP) from single blood donors, solvent/detergent-treated plasma (SD-plasma) pooled from several hundred blood donors has advantages with respect to pathogen reduction, standardized content of plasma proteins, and significantly reduced risk of transfusion related lung injury and allergic/ immunologic adverse reactions. However, SD-plasma has been suspected to increase the incidence of hyperfibrinolysis and thromboembolic events. Study Design and Methods:We investigated the transfusion practices, hyperfibrinolysis parameters, and thrombosis outcomes in 195 consecutive adult primary liver transplants in our center using SD-plasma (Octaplas) as the exclusive source of plasma.Results: Perioperatively, median (interquartile range) 4 (1 to 9) RBC-units, 10 (4 to 18) plasma-bags, and 0 (0 to 2) platelet-units were transfused. Hyperfibrinolysis defined as LY30 ≤ 7.5% was detected in 12/138 thrombelastography-monitored patients (9%). These patients received significantly more RBCs, plasma, and platelets than did patients without hyperfibrinolysis. Thrombotic graft complications were observed in three patients (2%). Pulmonary embolism was not observed in any patient. Conclusion:SD-plasma is a safe plasma product for liver transplant recipients, and the incidences of hyperfibrinolysis and thromboembolic events are not significantly different from those seen in centers using FFP.

show abstract

Section: Discussionmentioning

confidence: 99%

Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Haugaa

Taraldsrud

Nyrerød

et al. 2014

Clinical Medicine & Research

View full text Add to dashboard Cite

show abstract

“…Again, the quality of the new product was evaluated by use of biochemical and immunochemical methods, and significantly higher levels of a-2-antiplasmin have been demonstrated. However, the levels of fibrinogen and high molecular weight multimeric forms of von Willebrand factor (vWF) still remain reduced [43,44]. Reduction of high molecular forms of these two proteins seems to be due to filtration and additional chromatographic steps that are applied in production of the S/Dtreated plasma [39].…”

Section: Whole-blood Plasmamentioning

confidence: 97%

“…Reduction of high molecular forms of these two proteins seems to be due to filtration and additional chromatographic steps that are applied in production of the S/Dtreated plasma [39]. Recent investigations have proven that the S/D treatment and affinity chromatography procedure do not appear to adversely affect the haemostatic quality of the final product [44].…”

Section: Whole-blood Plasmamentioning

confidence: 99%

Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

et al. 2011

View full text Add to dashboard Cite

An overview is given on the application of proteomic technology in the monitoring of different steps during the production of therapeutic proteins from human plasma. Recent advances in this technology enable the use of proteomics as an advantageous tool for the validation of already existing processes, the development and fine tuning of new production steps, the characterization and quality control of final products, the detection of both harmful impurities and modifications of the therapeutic protein and the auditing of batch-to-batch variations. Further, use of proteomics for preclinical testing of new products, which can be either recombinant or plasma-derived, is also discussed.

show abstract

“…Plasma Units octaplasLG used in the thawing studies was produced at Octapharma AB, Stockholm, Sweden [12][13][14]. Seven octaplasLG batches of different blood groups (i.e., 2 A units, 1 B unit, 2 AB units AB and 2 O units) were thawed per thawing device used.…”

Section: Methodsmentioning

confidence: 99%

“…octaplas was first licensed in Europe in 1992. The second-generation octaplasLG ® product with implemented prion removal step is available in Europe, Canada, and the USA [12,13]. octaplasLG is a pharmaceutical product, thus, guidelines issued for human blood and blood components are not obligatory for this product.…”

Section: Introductionmentioning

confidence: 99%

Thawing of Pooled, Solvent/Detergent-Treated Plasma octaplasLG®: Validation Studies Using Different Thawing Devices

Heger

Pock

Römisch

2017

Transfus Med Hemother

View full text Add to dashboard Cite

Background: The aim of this study was to perform validation of the thawing process for solvent/detergent-treated plasma octaplasLG® using different thawing devices. Optimized settings for temperature and thawing time should be defined based on the results of both temperature measurements and extensive biochemical characterization studies. Methods: octaplasLG units were thawed using water bath systems (i.e. MB-13A, QuickThaw® DH4), dry tempering systems (i.e. plasmatherm, SAHARA-III), and microwave oven (i.e. transfusio-therm® 2000). Optimized thawing conditions were defined. Subsequently, using the selected thawing conditions, octaplasLG units were thawed and tested on product release parameters. Results: The fastest thawing was observed for the microwave oven. All octaplasLG units thawed by different devices and optimized thawing conditions were clear and free of solid and gelatinous particles, indicating no protein denaturation or overheating. In addition, no significant differences were found in the coagulation and inhibition activity and hemostatic potency of octaplasLG when thawed by the different devices tested. All parameters after thawing were within the product release specification levels. Conclusion: Our study demonstrated that octaplasLG can be thawed using all above listed devices without any negative influence on the plasma quality, presupposed that optimized settings defined for this plasma product are used.

show abstract

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

Abstract: 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.

Cited by 34 publications

References 33 publications

Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

Thawing of Pooled, Solvent/Detergent-Treated Plasma octaplasLG®: Validation Studies Using Different Thawing Devices

Contact Info

Product

Resources

About