Original and generic preservation solutions in organ transplantation. A new paradigm?

Abstract

Solid organ transplantation is a very complex process, in which the storage of the graft in a preservation solution is mandatory in order to extend ischemic times and contain further damage. The condition in which the organ is transplanted is critical for the outcome of the organ recipient. The recent emergence of generic versions of organ preservation solutions (solutions with the same composition and under the same legislation as the original versions, but with different brands) compelled us to study whether the standards are maintained when comparing the original and its generic counterpart. Along these lines, we discuss and comment on some aspects concerning this issue of general interest in the organ transplantation field.

Figure 1. Reduced glutathione levels (mmol/l) in preservation solutions from the same batch stored at different temperatures (5°C and 25°C) and evaluated at different times (initial, three months and six months). Results are expressed as mean ± SEM ( n = 3). a. p < 0.0005 indicates significant differences when comparing to 3 months at 5°C. b. p < 0.0005 indicates significant differences when comparing to 6 months at 5°C. Figure 1 b shows the degradation profile of reduced glutathione in the IGL-1 batches stored at 5°C or 25°C.