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.

An extraction freeze drying system. The freeze dryer has a cold collector, heating elements, and a vacuum chamber. A first removable collector vessel is operatively and removably connected to the freeze dryer. A second removable collector vessel is provided for replacing the first removable collector vessel upon removal thereof from the freeze dryer. The first and second removable collectors are jacketed vessels. Fluid is allowed to pass through the jacket to maintain proper temperatures. A sealable lid is attached to the first removable collector vessel immediately upon or prior to removal from the freeze dryer. The sealable lid comprises a drain valve and spout to aid in pouring off water or terpenes during the separation process.

An extraction freeze drying system. The freeze dryer has a cold collector, heating elements, and a vacuum chamber. A first removable collector vessel is operatively and removably connected to the freeze dryer. A second removable collector vessel is provided for replacing the first removable collector vessel upon removal thereof from the freeze dryer. The first and second removable collectors are jacketed vessels. Fluid is allowed to pass through the jacket to maintain proper temperatures. A sealable lid is attached to the first removable collector vessel immediately upon or prior to removal from the freeze dryer. The sealable lid comprises a drain valve and spout to aid in pouring off water or terpenes during the separation process.

Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.

Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.

The invention relates to a freeze-drying system for drying products containing liquid and to a method for operating a freeze-drying system, said freeze-drying system having a vacuum chamber, in which at least one holding device for holding the products containing liquid is inserted, a coolable condenser being provided, on which liquid drawn from the product in a drying phase can be condensed from a vapor phase. According to the invention, at least one sound generator is arranged on the holding device, by means of which sound generator sound can be applied to the product during the drying phase.

The invention relates to a freeze-drying system for drying products containing liquid and to a method for operating a freeze-drying system, said freeze-drying system having a vacuum chamber, in which at least one holding device for holding the products containing liquid is inserted, a coolable condenser being provided, on which liquid drawn from the product in a drying phase can be condensed from a vapor phase. According to the invention, at least one sound generator is arranged on the holding device, by means of which sound generator sound can be applied to the product during the drying phase.

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum.

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum.

A system to monitor and control a lyophilization process using a wireless network is disclosed which includes one or more wireless pressure and gas temperature sensors adapted to provide pressure and gas temperature measurements of the ambient environment, a lyophilization chamber, wherein the one or more wireless pressure sensors are distributed in one or more lyophilization vial trays, a vacuum pump, adapted to change the pressure with the lyophilization chamber, a heat exchanger adapted to modify temperature within the lyophilization chamber, and a controller adapted to collect pressure and gas temperature data from the one or more wireless pressure and gas temperature sensors, calculate sublimation rate of a product to be lyophilized using the collected pressure and gas temperature data, and adjust one or both of pressure and temperature within the lyophilization chamber such that the calculated sublimation rate stays within a predetermined envelope.