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

ABSTRACT:

Background

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.

Study design and methods

Three batches of OctaplasLG Lyo, manufactured for production process qualification, and 12 batches of OctaplasLG were provided by Octapharma AB (Sweden). Twelve units of fres

SUBMITTER: Heger A 

PROVIDER: S-EPMC10092463 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature