Frozen and freeze-dried solvent/detergent treated plasma: Two different pharmaceutical formulations with comparable quality.

Abstract

OctaplasLG is a frozen solvent/detergent-treated plasma product used for treating complex coagulation factor deficiencies or as substitution therapy in emergency situations where specific factor concentrates are not available. A new freeze-dried (also known as lyophilized) form of OctaplasLG, referred as OctaplasLG Lyo (Octapharma AG, Switzerland) offers rapid reconstitution and more flexible storage conditions, improving logistics and utilization. This study compared the biochemical quality of OctaplasLG Lyo with OctaplasLG and single-donor fresh frozen plasma units. Three batches of OctaplasLG Lyo, manufactured for production process qualification, and 12 batches of OctaplasLG were provided by Octapharma AB (Sweden). Twelve units of fresh frozen plasma were collected by the local FDA-licensed blood provider. All plasma samples were assessed for global coagulation parameters, coagulation factors and protease inhibitors, activation markers of coagulation and fibrinolysis, and important plasma proteins. Quality control assays were conducted in accordance with European Pharmacopeia requirements. Frozen and freeze-dried OctaplasLG demonstrated comparable quality profiles upon thawing or reconstitution. All coagulation factor and protease inhibitor activity parameters were in line with levels mandated by the European Pharmacopeia. Fresh frozen plasma units showed comparable coagulation factor activities, with higher protein S and plasmin inhibitor levels than the OctaplasLG products. Fresh frozen plasma parameters showed high lot-to-lot variations. The two pharmaceutical forms of OctaplasLG (frozen and freeze-dried) have comparable biochemical quality. Key features of OctaplasLG Lyo are rapid reconstitution time and storage flexibility, which may improve logistics and utilization, and have particular advantages in emergency situations and pre-hospital settings.