PB0541 - Freeze-dried plasma development and assessment of biochemical quality

Background: OctaplasLG® is a frozen solvent/detergent-treated, coagulation active plasma product for treating complex coagulation factor deficiencies and can be used as substitution therapy in situations where specific factor concentrates are not available, or in emergency situations where precise laboratory diagnosis is not possible. The recently developed freeze-dried pharmaceutical form, OctaplasLG® Lyo, a more convenient lyophilized form, offers faster reconstitution and more flexibility in storage conditions (refrigerated/room temperature), thus increasing ease of logistics and utilization.

Aims: To compare the biochemical quality of OctaplasLG® Lyo with OctaplasLG® and single-donor fresh frozen plasma (FFP) units.

Methods: Three OctaplasLG® Lyo batches for process performance qualification were manufactured at Octapharma AB (Stockholm, Sweden), freeze-dried, and reconstituted with sterilized water. Twelve batches of OctaplasLG® and FFP units were used for comparison. All plasma samples were assessed for global coagulation parameters, coagulation factors and protease inhibitors, activation markers of coagulation and fibrinolysis, as well as important plasma proteins.

Results: Frozen OctaplasLG® and freeze-dried OctaplasLG® Lyo demonstrate identical quality profiles upon thawing and reconstitution, respectively. All coagulation factor and protease inhibitor activity parameters were in line with levels mandated by the European Pharmacopoeia (Figure 1). FFP units show comparable coagulation factor activities, with higher protein S and plasmin inhibitor levels compared with the OctaplasLG® products. OctaplasLG® and OctaplasLG® Lyo parameters show lower bag-to-bag variation compared with FFP.

Conclusion(s): OctaplasLG® frozen and freeze-dried products have equally high biochemical quality. The key features of the new freeze-dried OctaplasLG® Lyo are the fast reconstitution time and flexibility of storage conditions (refrigerated/room temperature), which has advantages in emergency situations and in prehospital settings. In addition, the standardized content of plasma proteins in both OctaplasLG® products facilitates appropriate planning of high efficacy treatment.