Thirty years of experience with solvent/detergent‐treated plasma for transfusion medicine

Racine‐Brzostek, Sabrina E.; Cushing, Melissa M.; Gareis, Michelle; Heger, Andrea; Mehta Shah, Trupti; Scully, Marie

doi:10.1111/trf.17836

Transfusion

2024

DOI: 10.1111/trf.17836

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Thirty years of experience with solvent/detergent‐treated plasma for transfusion medicine

Sabrina E. Racine‐Brzostek,

Melissa M. Cushing,

Michelle Gareis

et al.

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2024

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Validation of current commercially‐available devices to thaw pooled, solvent/detergent‐treated human plasma

Heger,

Gareis

2024

Transfusion Medicine

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BackgroundProper thawing procedures are required to preserve the quality of human fresh frozen plasma (FFP). octaplasLG (Octapharma AG, Switzerland) is a frozen solution of solvent/detergent (S/D)‐treated human plasma, produced to improve pathogen safety. This study aimed to validate the S/D plasma thawing process using the latest‐generation of commercially‐available thawing devices and to determine S/D plasma quality after thawing.Study Design and MethodsThawing of S/D plasma units was investigated using a microwave oven (Transfusio‐therm 3000) and dry tempering systems (SAHARA 4 and Plasmatherm V). Times to defrost plasma and reach 30°C product temperature, using the 37°C thawing programmes, were defined for all devices. Thawed S/D plasma units were tested against product release parameters, as well as for hemostatic capacity tested indirectly via global coagulation parameters, coagulation factors, protease inhibitors and markers of activated coagulation.ResultsThe fastest thawing was observed using the microwave oven; S/D plasma units were defrosted after 2–3 min. All S/D plasma units thawed by the different devices using optimised thawing conditions were clear and free of solid and gelatinous particles, indicating no local overheating or protein denaturation. Coagulation factor and inhibitor activities and hemostatic capacity of S/D plasma were comparable when thawed by the three different devices. With each device, all product parameters were within product release specification levels after thawing.ConclusionsS/D plasma can be thawed using the Transfusio‐therm 3000, SAHARA 4 or Plasmatherm V thawing devices using the optimised settings defined for this plasma product, with no negative influence on plasma quality.

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Validation of current commercially‐available devices to thaw pooled, solvent/detergent‐treated human plasma

Heger,

Gareis

2024

Transfusion Medicine

View full text Add to dashboard Cite

show abstract

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Thirty years of experience with solvent/detergent‐treated plasma for transfusion medicine

Cited by 1 publication

References 86 publications

Validation of current commercially‐available devices to thaw pooled, solvent/detergent‐treated human plasma

Validation of current commercially‐available devices to thaw pooled, solvent/detergent‐treated human plasma

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