Biochemical quality of the pharmaceutically licensed plasma OctaplasLG^® after implementation of a novel prion protein (PrP^Sc) removal technology and reduction of the solvent/detergent (S/D) process time

Abstract

The studies confirmed that the affinity ligand chromatography under the developed conditions can be introduced into the Octaplas manufacturing process, as a mean to reduce potentially present PrP(Sc), without hampering the proven quality of this product.

Thawing of Pooled, Solvent/Detergent-Treated Plasma octaplasLG®: Validation Studies Using Different Thawing Devices

“…Plasma Units octaplasLG used in the thawing studies was produced at Octapharma AB, Stockholm, Sweden [12][13][14]. Seven octaplasLG batches of different blood groups (i.e., 2 A units, 1 B unit, 2 AB units AB and 2 O units) were thawed per thawing device used.…”

“…Eur. limits on human plasma pooled and treated for virus inactivation [17] and the product release specifications for octaplasLG [12]. In addition, there was no coagulation activation observed in any of the plasma bags thawed, and FVIIa levels were in the normal range for plasma.…”

“…Finally thrombin generation assay (TGA) was performed using the Technothrombin TGA test kit and the RC High trigger from Technoclone GmbH (Vienna, Austria). For more details of the test methods see [12,16].…”

“…octaplas was first licensed in Europe in 1992. The second-generation octaplasLG ® product with implemented prion removal step is available in Europe, Canada, and the USA [12,13]. octaplasLG is a pharmaceutical product, thus, guidelines issued for human blood and blood components are not obligatory for this product.…”

Stability of Trisodium Citrate and Gentamicin Solution for Catheter Locks after Storage in Plastic Syringes at Room Temperature

“…Both gentamicin and citrate have been shown to be stable for 6 months when frozen and stored at -20°C. 23,24 For gentamicin analysis, the samples were diluted 1:1 with water to give a nominal concentration of 250 g/mL; phenylisocyanate derivatives were prepared from 0.5-mL volumes of these solutions, as previously described, and analyzed by means of HPLC. For citrate analysis, samples were diluted 1:25 with water to generate a nominal concentration of 1600 µg/mL, and these solutions were analyzed by HPLC.…”