| CPC A61K 35/19 (2013.01) [A61K 38/1825 (2013.01); A61K 38/1858 (2013.01); A61L 2/00 (2013.01); A61L 2/0005 (2013.01); A61L 2/0088 (2013.01); A61L 2202/22 (2013.01)] | 11 Claims |
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1. A viral-safe liquid mixture composition comprising a solvent detergent (S/D) agent, said S/D agent being present at a concentration of below 5 ppm, ethanol, sodium chloride, an amphiphilic polymer being polyvinylpyrrolidone (PVP) having: (i) an average molecular weight in the range of about 3.5 to lower than about 40 kilodalton, (ii) a K-value of above 10 to below 33, and (iii) being at a concentration in the range of about 0.01 to 6 mM; and a platelet extract or lysate comprising at least one growth factor; the at least one growth factor being mixed with said PVP in the viral-safe liquid mixture, and being characterized by increased biological potency with regard to the growth of 3T3-Swiss albino fibroblasts cells as determined by a median effective concentration (EC50), as compared to a control extract comprising heparin and being free of PVP, the viral-safe liquid mixture composition being obtained by a method comprising the following steps: providing a biological source as a clear solution; providing a non-toxic amphiphilic polymer having an average molecular weight in the range of about 3.5 to lower than about 40 kilodalton, the PVP; treating the source with an S/D agent to allow viral inactivation; treating the source with the amphiphilic polymer at a final concentration of 0.01 to 6 mM wherein the clarity of the solution is maintained; removing the S/D agent by contacting the treated source with an hydrophobic interaction chromatography (HIC) resin; and collecting a material comprising an unbound fraction from HIC; wherein the method comprises at least one more orthogonal viral inactivation treatment, thereby obtaining the viral-safe liquid mixture composition.
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