Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

A heating device (124) for heating particles to be freeze-dried in a rotary drum (102) of a freeze-dryer (100) is provided, the device comprising at least one radiation emitter (202) for applying radiation heat to the particles, and a tube-shaped separator (204) for separating the particles from the at least one emitter (202), The separator (202) being integrally closed at one end and separating an emitter volume (206) encompassing the at least one emitter (202) from a drum process volume (126) inside the drum (102), wherein the heating device (124) protrudes into the drum process volume (126) such that said integrally closed end of the separator (204) is arranged inside the drum (102) as a free end.

A heating device (124) for heating particles to be freeze-dried in a rotary drum (102) of a freeze-dryer (100) is provided, the device comprising at least one radiation emitter (202) for applying radiation heat to the particles, and a tube-shaped separator (204) for separating the particles from the at least one emitter (202), The separator (202) being integrally closed at one end and separating an emitter volume (206) encompassing the at least one emitter (202) from a drum process volume (126) inside the drum (102), wherein the heating device (124) protrudes into the drum process volume (126) such that said integrally closed end of the separator (204) is arranged inside the drum (102) as a free end.

A method for performing a multi-phase extraction of plant biomass to obtain active substances is provided. The method uses a novel freeze-dry extraction technique to obtain a volatile terpene fraction from frozen plant material. In particular, the method disclosed provides terpene extracts with compositions that strongly resemble that of the parent plant material.

Roll-to-roll freeze-drying (lyophilization) system and process for facilitating freeze-drying processes and enabling the collection of data by which a freeze-drying process can be monitored and evaluated. Such a system includes a roll-to-roll freeze-drying apparatus adapted to continuously freeze and dry a liquid to form a freeze-dried and encapsulate freeze-dried sheet portions of the freeze-dried sheet to create premeasured pouches containing the freeze-dried sheet portions. The system further includes a metrology section that monitors any of the freeze-dried sheet and the freeze-dried sheet portions during the freezing and drying of the liquid to generate data for controlling the freezing and drying of the liquid.

Roll-to-roll freeze-drying (lyophilization) system and process for facilitating freeze-drying processes and enabling the collection of data by which a freeze-drying process can be monitored and evaluated. Such a system includes a roll-to-roll freeze-drying apparatus adapted to continuously freeze and dry a liquid to form a freeze-dried and encapsulate freeze-dried sheet portions of the freeze-dried sheet to create premeasured pouches containing the freeze-dried sheet portions. The system further includes a metrology section that monitors any of the freeze-dried sheet and the freeze-dried sheet portions during the freezing and drying of the liquid to generate data for controlling the freezing and drying of the liquid.

The present invention provides, inter alia, for a liquid feeding device for the generation of droplets, in particular for the use in a process line for the production of freeze-dried particles, with a droplet ejection section for ejecting liquid droplets in an ejection direction, the droplet ejection section comprising at least one inlet port for receiving a liquid to be ejected, a liquid chamber for retaining the liquid, and a nozzle for ejecting the liquid from the liquid chamber to form droplets, wherein the liquid chamber is restricted by a membrane on one side thereof, the membrane being vibratable by an excitation unit, wherein the longitudinal axis of the liquid chamber is tilted relative to the longitudinal axis of the nozzle, and/or the liquid feeding device further comprises a deflection section for separating the droplets from each other by means of at least one gas jet, wherein the deflection section gas jet intersects perpendicular with an ejection path of the liquid ejected from the liquid chamber.

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

Provided are a vacuum freeze-drying apparatus and a method capable of continuously performing vacuum freeze-drying in a short time. A vacuum freeze-drying apparatus 1 of this invention having an exhaust path for performing vacuum suction, while a drying device 3 comprises a tubular member 31 provided an inlet portion and an outlet portion formed of a tubular shape, a temperature adjusting means 30a to 30j provided in a plurality of regions formed from the inlet portion toward the outlet portion in a peripheral portion of the tubular member 31 wherein the plurality of regions are at least three or more regions whose temperature is capable of being controlled, for adjusting temperatures of a plurality of regions 40a to 40j in outer surface of the tubular member, a temperature control unit 8 for independently controlling the temperature adjusting means, and a rotating portion 7 for rotating the tubular member 31, wherein the tubular member 31 has a spiral transfer means 31a continuously provided adjacent to an inner wall of the tubular member from the inlet portion toward the outlet portion, and the transfer means 31a transfers the frozen substance sequentially to locations corresponding to the plurality of regions in the tubular member so as to continuously sublimate and dry.

Provided are a vacuum freeze-drying apparatus and a method capable of continuously performing vacuum freeze-drying in a short time. A vacuum freeze-drying apparatus 1 of this invention having an exhaust path for performing vacuum suction, while a drying device 3 comprises a tubular member 31 provided an inlet portion and an outlet portion formed of a tubular shape, a temperature adjusting means 30a to 30j provided in a plurality of regions formed from the inlet portion toward the outlet portion in a peripheral portion of the tubular member 31 wherein the plurality of regions are at least three or more regions whose temperature is capable of being controlled, for adjusting temperatures of a plurality of regions 40a to 40j in outer surface of the tubular member, a temperature control unit 8 for independently controlling the temperature adjusting means, and a rotating portion 7 for rotating the tubular member 31, wherein the tubular member 31 has a spiral transfer means 31a continuously provided adjacent to an inner wall of the tubular member from the inlet portion toward the outlet portion, and the transfer means 31a transfers the frozen substance sequentially to locations corresponding to the plurality of regions in the tubular member so as to continuously sublimate and dry.