Analyzing GMP-Compliant Manufactured Human Platelet Lysate From Thrombocyte-Apheresis In Additive-Solution

Appropriate culture conditions are essential for the viability and proliferation of cells. Culture media consists of a basal medium that is supplemented with eligible growth factors and cytokines. The use of human platelet lysate (PL) is a suitable alternative to FCS, preventing the problem of transfer of animal components and triggering of immune responses during cell therapies required by authorities. GMP-compliant production of platelet lysate from donor thrombocyte-apheresis taken in additive solution (PAS) was performed and analyzed.

During GMP-compliant platelet lysate manufacture, platelets were lysed in order to achieve the release of growth factors from platelets' alpha granules, centrifuged, and sterile filtered. In order to evaluate the suitability of human platelet lysate for the in vitro culturing of different cell lines, the proliferation of these cells under PL culture conditions was analyzed using a colorimetric MTS-based proliferation assay. Proliferation of cells cultivated either in PL in additive solution or PL in plasma or FCS were compared. For the quantitative determination of human platelet-derived growth factor a PDGF-assay was used.

Quantitative determination of human platelet-derived growth factor using PDGF-assay showed that the measured values of platelet lysate manufactured from thrombocyte-apheresis in additive solution were comparable to platelet lysate produced from plasma-rich thrombocyte apheresis. Significantly higher metabolic activities of cell lines cultured in platelet lysate than under FCS culture conditions as measured by MTS-based assay was detected. Furthermore, the results of proliferation assays of various cell lines cultivated in different PL revealed comparable metabolic activities of cells.

In the present study cell proliferation of different cell lines under FCS and platelet lysate culturing was compared. GMP-compliant produced platelet lysate from donor thrombocyte-apheresis taken in additive-solution for supplementing culture media for cell cultivation for cell therapies is appropriate for clinical use in cell culture.

I declare there is no conflict of interest.