L-GF preparation
STERILE, VIRUS
L-GF was supplied as a powder in a tightly sealed container. The amount of growth factors in each vial was standardized, equivalent to those obtained from a platelet count of 106/μl found in 20 ml of whole blood.The platelet concentrate was subjected to a first pathogen reduction step via UV irradiation using the Mirasol TM system that disrupts RNA and/or DNA of microorganisms, including enveloped, non-enveloped virus, bacteria, fungi, etc. Then, the platelets are activated to release part of the alpha granules and growth factors present therein, thereby providing a fluid platelet releasate, which is subjected to a fibrinogen reduction step to obtain a fibrinogen-depleted fluid platelet releasate (for easy administration in intralesional injections). A second confirmatory pathogen concentration reduction step was taken to disrupt enveloped viruses. Finally, sterile filtering of platelet releasate was performed, and a filtrate liquid containing growth factors was produced and freeze-dried to form a powder [