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AssigneeErytech Pharma
InventorYann GODFRIN
Estimating the term…
A lysis/resealing process for preparing erythrocytes containing active ingredient is provided comprising placing a globular concentrate in suspension in an isotonic solution having a haematocrit level which is equal to or greater than 65%, with refrigeration at 1 to 8° C.; measuring the osmotic fragility based on a sample of erythrocytes from that same globular concentrate, preferably on a sample of the suspension; lysis and internalisation procedure of the active ingredient, inside the same chamber, at a temperature maintained at 1 to 8° C., comprising allowing the erythrocyte suspension having a haematocrit level equal to or greater than 65% and a hypotonic lysis solution which is refrigerated at 1 to 8° C., to circulate in a dialysis cartridge; the lysis parameters being adjusted in accordance with the osmotic fragility previously measured; and resealing in a second chamber at a temperature of from 30 to 40° C. by means of a hypertonic solution.
A lysis device for preparing erythrocytes which contain an active ingredient, wherein the device comprises a module which may be cooled, and a sterile, single-use removable assembly which is configured in order to be able to be placed in the module and which comprises a dialysis cartridge which can be connected, at one side, to an inlet for a lysis solution and, at the other side, to an inlet for an erythrocyte suspension, wherein the module maintains the temperature at from +1 to +8° C. and adjusts the flow rate of the erythrocyte suspension through the dialysis cartridge and/or adjusts the osmolarity of the lysis solution, in accordance with the osmotic fragility of the erythrocytes to be processed.
Dependencies are inferred from the claim text.