CPC B01D 61/14 (2013.01) [C12N 5/0644 (2013.01); B01D 2311/12 (2013.01); B01D 2315/10 (2013.01); B01D 2315/16 (2013.01)] | 25 Claims |
1. A process for preparing a thermally-treated platelet composition, the process comprising:
performing tangential flow filtration (TFF) of a platelet composition comprising platelets in a preparation agent comprising a buffering agent, between 10 mM and 1000 mM of saccharides comprising a monosaccharide and/or a disaccharide, and polysucrose in an amount in the range of 3% to 7%, wherein the TFF is performed until a particular residual plasma protein endpoint is reached, thereby preparing a TFF-treated composition comprising at least 1000×103 platelets/μl in an aqueous medium having less than or equal to 15% plasma protein and having less than 5.0% microparticles by scattering intensity;
freeze drying the TFF-treated composition comprising platelets in the aqueous medium to form a freeze-dried platelet composition; and
heating the freeze-dried platelet composition at a temperature in the range of 60° C. to 85° C. for at least 1 hour to not more than 36 hours to thermally treat the freeze-dried platelets in the freeze-dried platelet composition to form the thermally-treated platelet composition,
wherein the thermally-treated platelets in the thermally-treated platelet composition are capable of generating thrombin in an in vitro thrombin formation assay.
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