title: A biochemical comparison of a pharmaceutically licensed coagulation active plasma (Octaplas) with a universally applicable development product (Uniplas) and single-donor FFPs subjected to methylene-blue dye and white-light treatment.
abstract: The strive for more standardised and highly efficacious products is one of the important mainstays in modern haemotherapy. Coagulation active plasma for transfusion is the product of choice when treating hereditary or acquired isolated or complex coagulopathies, when no specific concentrate is available. The aim of this study was to perform an extensive biochemical comparison of the pharmaceutically licensed coagulation active plasma named Octaplas with an identical, but universally applicable, development product (Uniplas, working title) and single-donor fresh-frozen plasma (FFP) units subjected to a medical device treatment using a combination of methylene-blue dye and subsequent white-light exposure (MB plasma). Our study showed that there are differences in the biochemical characteristics between Octaplas and MB plasma, while Uniplas revealed the same quality as Octaplas. The variability of selected plasma proteins in the 20 individual MB plasma units tested was high compared to Octaplas/Uniplas. Beyond the reported decreased levels of protein S and plasmin inhibitor found in Octaplas/Uniplas, and the significant loss of fully functional fibrinogen in MB plasma and its impact on selected global coagulation parameters, the latter product additionally revealed several coagulation factor activities outside the ranges given for normal single-donor FFP. It is important for plasma prescribers to be aware of the major inherent differences between Octaplas and MB plasma.
authors.affiliation: Octapharma Pharmazeutika Produktionsges.m.b.H, Pre-Clinical Research and Development Department, Oberlaaer Strasse 235, A-1100 Vienna, Austria. andrea.heger@octapharma.at
authors.forename: Andrea
authors.initials: A
authors.lastname: Heger
authors.forename: Jürgen
authors.initials: J
authors.lastname: Römisch
authors.forename: Tor-Einar
authors.initials: TE
authors.lastname: Svae
mesh_terms: D001777:Blood Coagulation / Q000187:drug effects / Q000528:radiation effects; D001780:Blood Coagulation Tests; D001798:Blood Proteins / Q000187:drug effects / Q000528:radiation effects; D006801:Humans; D008027:Light; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000097:blood; D008751:Methylene Blue / Q000494:pharmacology*; D010949:Plasma / Q000737:chemistry / Q000187:drug effects* / Q000528:radiation effects*; D010958:Plasminogen / Q000032:analysis; D011480:Protease Inhibitors / Q000097:blood; D015203:Reproducibility of Results; D012697:Serine Endopeptidases / Q000097:blood
chemical_list: D001798:Blood Proteins; D008055:Lipids; D008074:Lipoproteins; D011480:Protease Inhibitors; D010958:Plasminogen; C433550:HABP2 protein, human; D012697:Serine Endopeptidases; D008751:Methylene Blue