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A BIOCHEMICAL COMPARISON OF A PHARMACEUTICALLY LICENSED S/D TREATED PLASMA WITH A UNIVERSALLY APPLICABLE DEVELOPMENT PRODUCT AND SINGLE-DONOR FFPS SUBJECTED TO METHYLENE-BLUE DYE AND WHITE-LIGHT TREATMENT
Abstract number: P-S-294
Heger1 A., Römisch1 J., Svae2 T.
11PreClinical Research and Development 22Corporate Product Development Department, Octapharma PPGmbH, Vienna, Austria
How-to-cite Heger A, Römisch J, Svae T. A BIOCHEMICAL COMPARISON OF A PHARMACEUTICALLY LICENSED S/D TREATED PLASMA WITH A UNIVERSALLY APPLICABLE DEVELOPMENT PRODUCT AND SINGLE-DONOR FFPS SUBJECTED TO METHYLENE-BLUE DYE AND WHITE-LIGHT TREATMENT. J Thromb Haemost 2007; 5 Supplement 2: P-S-294
Abstract
Introduction: The aim of this study was to perform an biochemical comparison of the pharmaceutically licensed coagulation active and S/D-treated plasma (Octaplas®) with an identical, but universally applicable, development product (working title: Uniplas) 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).
Methods: Twenty-four lots of S/D plasma (Octaplas®), 3 lots of Uniplas (both products manufactured by Octapharma PPGmbH, Vienna, Austria) and 20 commercially available bags of MB plasma were analysed. Beyond the global coagulation parameters, the activities of coagulation factors and protease inhibitors, plasminogen, activated factor VII, plasma turbidity and lipids were quantified.
Results: Both S/D plasma products (Octaplas®, Uniplas) showed standardised levels of coagulation factors, plasminogen and protease inhibitors (decreased protein S and antiplasmin activities) according to the product specifications. MB plasma revealed fibrinogen levels close to or below the physiological range. Coagulation factor activities in single MB plasma units both below and above the normal ranges for FFP were found in this study, reflecting the considerable variability of clinically important plasma proteins. Moreover, MB plasma revealed a higher turbidity after thawing.
Conclusions: The study showed that there are significant differences in the biochemical characteristics between S/D treated plasma (Octaplas® /Uniplas) and MB plasma. The variability of several plasma proteins in MB plasma units tested was high compared to the biopharmaceutical plasma products. For plasma prescribers and physicians it is also important to consider the significant loss of functional fibrinogen in MB plasma when planning and monitoring the treatment of severely ill patients.
To cite this abstract use the following format:
Journal of Thrombosis and Haemostasis 2007; Volume 5, Supplement 2: abstract number
Session Details
| Date: |
01/08/2007
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| Time: |
00:00-00:00
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| Session name: |
XXIst ISTH Congress |
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| Location: |
Oxford, UK |
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