EP3050556A1 — Process for manufacturing a pharmaceutical preparation containing glatiramer acetate

USPTO Abstract

The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0°C up to 17.5°C to produce a filtrate; and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40mg/ml glatiramer acetate and 40mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa; or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.