Method for the production of one-dose syringe comprising a freeze-dried protein with injectable volume of lees 0.5 ml

摘要

It is described method for the production of one-dose syringe comprising a freeze-dried protein in first chamber and an aqueous solution in a second chamber included Steps of filling the first chamber with a composition comprising a protein in an amount of less than 1.4 mg, stabiliser and amino acid where the weight ratio between protein and amino acid versus stabiliser is less than 1.5, free-drying the first chamber to form the cake in which the ratio of the weight of the dry component versus the cake volume is above 12 mg ml-1, filling the second chamber with an aqueous reconstitution solution with an injectable volume of less than 0.5 ml.