摘要:
A container closure system for use in lyophilization processes employing depressurization to initiate nucleation is provided. The present container closure system includes a container and a closure element disposed proximate to and adapted for sealing the opening of the container. The closure element includes a first sealing surface adapted for sealably contacting an interior surface of the container and a second sealing surface adapted for sealably contacting the top surface of the container when the container closure system is in a closed position. The closure element also includes a plurality of closure legs extending from the second sealing surface that define a plurality of side vents between each of the closure legs when the container closure system is in the open position. The length, thickness, number, and shape of the legs are chosen to produce an effective total side vent area that is at least 50% of the area of the container opening. Alternatively, the length, thickness, number, and shape of the legs are chosen to produce an effective total side vent area that is greater than the cumulative surface area of the outwardly facing surface of the closure legs.
摘要:
System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.
摘要:
A bioreactor with an upward flowing impeller system for controlling a mammalian cell culture process is provided. The disclosed system enables control of the cell culture process by controlling the level of dissolved carbon dioxide in the cell culture media and prevent increases in the osmolality level is achieved by enhanced stripping of carbon dioxide via surface gas exchange with little or no damage to the mammalian cells. The use of an upward flow impeller combined with vertical baffles converts the swirling motions of the cell culture media into a largely vertical flow and promotes the removal of dissolved carbon dioxide via surface gas exchange with a sweep gas flowing over the top surface of the cell culture media within the bioreactor vessel.
摘要:
Methods of inducing nucleation of a material is provided. The disclosed methods comprise the steps of bringing the material to a temperature near or below a phase transition temperature and altering the pressure to induce nucleation of the material. The disclosed methods are useful in freeze-drying processes, particularly pharmaceutical freeze-drying processes.
摘要:
System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.
摘要:
System and method for lyophilization or freeze-drying is provided. During the freezing step, the material or solution to be frozen is initially brought to a temperature near or below its freezing temperature after which the pressure in the freeze-dryer chamber is reduced to induce nucleation of the material.
摘要:
A bioreactor with an upward flowing impeller system for controlling a mammalian cell culture process is provided. The disclosed system enables control of the cell culture process by controlling the level of dissolved carbon dioxide in the cell culture media and prevent increases in the osmolality level is achieved by enhanced stripping of carbon dioxide via surface gas exchange with little or no damage to the mammalian cells. The use of an upward flow impeller combined with vertical baffles converts the swirling motions of the cell culture media into a largely vertical flow and promotes the removal of dissolved carbon dioxide via surface gas exchange with a sweep gas flowing over the top surface of the cell culture media within the bioreactor vessel.
摘要:
A system and method for controlling a mammalian cell culture process are provided. Such control of the cell culture process involves control of the level of dissolved carbon dioxide in the cell culture media and the resulting ability to prevent increases in the osmolality level is achieved by enhanced stripping of carbon dioxide with little or no damage to the mammalian cells. The disclosed methods and systems of dissolved carbon dioxide stripping include enhanced surface gas exchange mechanisms within the bioreactor vessel through the use of an upward flow impeller combined with vertical baffles to convert swirling motions of the liquid into a largely vertical flow.
摘要:
Methods of inducing nucleation of a material is provided. The disclosed methods comprise the steps of bringing the material to a temperature near or below a phase transition temperature and altering the pressure to induce nucleation of the material. The disclosed methods are useful in freeze-drying processes, particularly pharmaceutical freeze-drying processes.
摘要:
A system and method for controlling a mammalian cell culture process are provided. Such control of the cell culture process involves control of the level of dissolved carbon dioxide in the cell culture media and the resulting ability to prevent increases in the osmolality level is achieved by enhanced stripping of carbon dioxide with little or no damage to the mammalian cells. The disclosed methods and systems of dissolved carbon dioxide stripping include enhanced surface gas exchange mechanisms within the bioreactor vessel through the use of an upward flow impeller combined with vertical baffles to convert swirling motions of the liquid into a largely vertical flow.