Abstract: A method of manufacturing a flexible container housing a drug substance is disclosed that includes forming a first compartment from a flexible sheet-like material, filling a liquid into the first compartment, sealing the first compartment, forming a second compartment from the flexible sheet-like material, filling a dry drug formulation into the second compartment, and sealing the second compartment. The method further involves lyophilizing the drug formulation inside a tubular cartridge, filling the second compartment by introducing the tubular cartridge through an opening of the second compartment such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment, providing the drug formulation from the open end of the tubular cartridge into the second compartment, and withdrawing the tubular cartridge from the second compartment. The first and second compartments are separated by a frangible seal which opens when the first compartment is compressed.

Abstract: A lyophilisate retainer for lyophilizing a substrate is disclosed that includes a three dimensional scaffold body having pores. The pores of the scaffold body are configured to receive and hold the substrate. The scaffold body is made of a scaffold material providing heat transfer properties in lyophilisation to induce heat transfer to the substrate held in the pores of the scaffold body.

Abstract: A method of generating a lyophilized drug formulation (2) comprises: preparing a substrate to be additive manufacturable, wherein the substrate comprises a drug; additive manufacturing the substrate such that a scaffold body (21) is formed of the substrate; and lyophilizing the scaffold body (21).

Abstract: A method of manufacturing a flexible container (1) housing a drug substance, comprises: forming a first compartment (11) of the container (1) out of a flexible sheet-like material, filling a liquid (2) into the first compartment (11) of the container (1), sealing the first compartment (11), forming a second compartment (12) of the container (1) out of the flexible sheet-like material, filling a dry drug formulation (3) into the second compartment (12), and sealing the second compartment (12).

Abstract: A lyophilisate container (39) comprising a compartment; a wall (3119, 3129) limiting the compartment; and a lyophilisate arranged inside the compartment. At least a portion of the wall (3119, 3129) is semipermeable allowing vapour permeation in one direction out of the compartment through the wall (3119, 3129) and preventing vapour permeation in an opposite direction into the compartment through the wall (3119, 3129).