Freeze-Dried Plasma as a Treatment Option in Pre-Hospital and Emergency Settings

The key features of freeze-dried plasma (FDP) are rapid reconstitution time and storage flexibility (refrigerated/room temperature), which may improve logistics and utilization, and have advantages in emergency situations and pre-hospital settings. OctaplasLG powder is a new pharmaceutical form of the OctaplasLG pharmaceutically-licensed, pooled, solvent/detergent-treated, standardized human plasma for transfusion. This study aimed to compare the biochemical quality of OctaplasLG powder with single-donor fresh frozen plasma (FFP), the OctaplasLG frozen variant and FDP comparators. OctaplasLG powder is filled and lyophilized in glass vials and can be reconstituted within 5–10 min right before use with water for injection provided in a flexible bag. The lyophilized product can be stored at room temperature for up to 2 years. OctaplasLG batches, both frozen and freeze dried, all manufactured at Octapharma AB (Sweden) were investigated. Single-donor FFP units were used as frozen plasma variants, while LyoPlas N (DRK-Blutspendedienst West, Germany) and Bioplasma FDP (National Bioproducts Institute, South Africa) were used as FDP comparators. All products were assessed for global coagulation parameters, coagulation factors and protease inhibitors, as well as activation markers of coagulation and fibrinolysis. After reconstitution, OctaplasLG powder was clear and free of solid or gelatinous particles. All coagulation factor and protease inhibitor activity parameters were comparable to that found in the frozen product, and in line with the product release specifications (Figure A). Single-donor FFP and LyoPlas N units after thawing/reconstitution showed increased turbidity. Coagulation factor and inhibitor activities in FFP and LyoPlas N were comparable to that of OctaplasLG batches, with significantly higher levels of plasmin inhibitor in the comparators (Figure A). All coagulation factor and inhibitor activities were notably lower in Bioplasma FDP compared to all other products investigated. The freeze-dried OctaplasLG product shows reliably high biochemical quality comparable to the frozen product. The new pharmaceutical form, in addition, enables advantages in logistics and utilization, especially in emergency situations and pre-hospital settings.