Provided is a vacuum freeze-drying apparatus 1, having a drying device 3 provided with an inlet portion and an outlet portion and comprising a tubular member 31 formed of a tubular shape, a temperature adjusting means 30a to 30j provided in a plurality of regions 40a to 40j in a direction from the inlet portion to the outlet portion in a peripheral portion of the tubular member for adjusting a temperature of the plurality of regions in an 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, wherein the tubular member has a spiral transfer means 31a for transferring the frozen substance entering from the inlet portion sequentially to locations corresponding to the plurality of regions in the tubular member to continuously sublimate and dry the frozen substance.

A freeze drying vessel (302) having a freeze drying chamber (304) that includes sloped horizontal shelves (352) that receive frozen particles (282). Each shelf is sloped relative to a horizontal axis (390) and arranged such that a downward slope between successive shelves alternates between first (392) and second (394) directions. At least one connecting member (374, 376, 378, 380, 382, 384, 386, 386, 388) is attached between pairs of shelves. At least one connecting member is attached to an associated vibration element (396, 398, 400, 402) located outside the drying chamber. Each vibration element vibrates a pair of shelves to cause the frozen particles to advance relative to an associated shelf and drop downward from shelf to shelf wherein the shelves heat the frozen particles to promote sublimation to form freeze dried product (284).

Various implementations of a freeze-drying method are described where the material is cooled by reducing the pressure in a chamber to evaporate and/or sublimate water in the material. In one implementation, the material is dried in the chamber by sublimating ice in the material to water vapor. In another implementation, the freeze-drying method includes actively cooling the chamber. In another implementation, at least a portion of the water vapor is deposited on an actively cooled interior surface of the chamber. In another implementation, the freeze-drying method includes cooling the material to −25° F. or below. In another implementation, the material is cooled at approximately ambient pressure to 30° F. or below and then cooled by reducing the pressure in the chamber.

A method of treatment of plasma with a physiologically compatible spray dry stable acidic substance (SDSAS) prior to or contemporaneously with spray drying of the plasma that results in greater recovery and greater long-term stabilization of the dried plasma proteins as compared to spray dried plasma that has not be subject to the formulation method of the present invention, as well as compositions related to plasma dried by the methods of the present invention.

A freeze drying vessel (302) having a freeze drying chamber (304) that includes sloped horizontal shelves (352) that receive frozen particles (282). Each shelf is sloped relative to a horizontal axis (390) and arranged such that a downward slope between successive shelves alternates between first (392) and second (394) directions. At least one connecting member (374, 376, 378, 380, 382, 384, 386, 386, 388) is attached between pairs of shelves. At least one connecting member is attached to an associated vibration element (396, 398, 400, 402) located outside the drying chamber. Each vibration element vibrates a pair of shelves to cause the frozen particles to advance relative to an associated shelf and drop downward from shelf to shelf wherein the shelves heat the frozen particles to promote sublimation to form freeze dried product (284).

Provided is a process for providing a flake powder characterized by a particle size of −40 mesh to +200 mesh; a Scott density of at least 1.458 g/cm.sup.3; and a flow of at least 1 g/s. The process includes introducing a milled flake powder in a solvent to a first dryer; removing the solvent at a temperature below a melting point of the solvent under a reduced atmosphere to obtain a partially dry flake powder; and introducing the partially dry flake powder to a second dryer to form flake powder wherein particles of partially dry flake powder are heated and simultaneously subjected to an uncorrelated motion relative to adjacent particles.

Provided is a vacuum freeze-drying apparatus 1, having a drying device 3 provided with an inlet portion and an outlet portion and comprising a tubular member 31 formed of a tubular shape, a temperature adjusting means 30a to 30j provided in a plurality of regions 40a to 40j in a direction from the inlet portion to the outlet portion in a peripheral portion of the tubular member for adjusting a temperature of the plurality of regions in an 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, wherein the tubular member has a spiral transfer means 31a for transferring the frozen substance entering from the inlet portion sequentially to locations corresponding to the plurality of regions in the tubular member to continuously sublimate and dry the frozen substance.

A method of treatment of plasma with a physiologically compatible spray dry stable acidic substance (SDSAS) prior to or contemporaneously with spray drying of the plasma that results in greater recovery and greater long-term stabilization of the dried plasma proteins as compared to spray dried plasma that has not be subject to the formulation method of the present invention, as well as compositions related to plasma dried by the methods of the present invention.

A method for the production of freeze-dried pellets comprising an anti-FXIa antibody comprises the steps of: a) freezing droplets of a solution comprising an anti-FXIa antibody to form pellets; b) freeze-drying the pellets; wherein in step a) the droplets are formed by means of droplet formation of the solution comprising an anti-FXIa antibody into a cooling tower which has a temperature-controllable inner wall surface and an interior temperature below the freezing temperature of the solution and wherein in step b) the pellets are freeze-dried in a rotating receptacle which is housed inside a vacuum chamber.

The present invention refers to novel liquid pharmaceutical high-concentration formulations particularly suitable for subcutaneous administration comprising human antibodies against coagulation factor FXIa as active ingredient, especially those described in WO2013167669, which are stable as liquid formulations over a long period. The invention also refers to lyophilizates of the specified liquid formulation with reduced reconstitution time and also to the use of these formulations in the therapy and prophylaxis of thrombotic or thromboembolic disorder.