Abstract: The present disclosure relates to inhalable dry powder formulations comprising one or more antibodies or one or more angiogenesis inhibiting active pharmaceutical ingredients, methods of manufacture of such compositions, e.g., via spray drying, as well as their local administration to the lung for use in the treatment, prevention and/or delay of progression of asthma, COPD, lung infections, cystic fibrosis, or lung cancer.

Abstract: A pharmaceutical composition comprises multiparticulates comprising a melt-congeal core and a solid amorphous dispersion layer of a poorly water soluble drug and polymer. The multiparticulates are suitable for improving bioavailability of poorly water soluble drugs. The melt-congeal cores facilitate application of the solid amorphous dispersion layer, and allow incorporation of additional optional components to the core so as to adjust the release of drug from the multiparticulate.

Abstract: The present disclosure is directed to systems and methods for sampling and/or controlling the productivity of a bioreactor. The system and methods can include a vessel capable of providing an environment suitable for containing whole broth that can produce the bioproduct, wherein the whole broth contains media and at least one undissolved species, an automated sampling system, a first analytical instrument, and a control system.

Abstract: The present disclosure is directed to systems and methods for sampling and/or controlling the productivity of a bioreactor. The system and methods can include a vessel capable of providing an environment suitable for containing whole broth that can produce the bioproduct, wherein the whole broth contains media and at least one undissolved species, an automated sampling system, a first analytical instrument, and a control system.

Abstract: The process comprises delivering a spray solution comprising an active agent and a matrix material in an organic solvent to a spray-drying apparatus, atomizing the spray solution into droplets within the spray-drying apparatus to remove at least a portion of the organic solvent from the droplets to form a plurality of particles, and collecting the particles. The spray solution may be formed by forming a feed suspension comprising the active agent, the matrix material, and the organic solvent, wherein the feed suspension is at a temperature T1, and directing the feed suspension to a heat exchanger, thereby increasing the temperature of the feed suspension to a temperature T2, wherein T2 is greater than T1, and the spray solution is at a pressure greater than the vapor pressure of the organic solvent at T2, such that the active agent and matrix material are soluble in the organic solvent at T2.

Abstract: The present disclosure is directed to systems and methods for sampling and/or controlling the productivity of a bioreactor. The system and methods can include a vessel capable of providing an environment suitable for containing whole broth that can produce the bioproduct, wherein the whole broth contains media and at least one undissolved species, an automated sampling system, a first analytical instrument, and a control system.

Abstract: A pharmaceutical composition comprises multiparticulates comprising a melt-congeal core and a solid amorphous dispersion layer of a poorly water soluble drug and polymer. The multiparticulates are suitable for improving bioavailability of poorly water soluble drugs. The melt-congeal cores facilitate application of the solid amorphous dispersion layer, and allow incorporation of additional optional components to the core so as to adjust the release of drug from the multiparticulate.

Abstract: The present disclosure is directed to systems and methods for sampling and/or controlling the productivity of a bioreactor.

Abstract: The process comprises delivering a spray solution comprising an active agent and a matrix material in an organic solvent to a spray-drying apparatus, atomizing the spray solution into droplets within the spray-drying apparatus to remove at least a portion of the organic solvent from the droplets to form a plurality of particles, and collecting the particles. The spray solution may be formed by forming a feed suspension comprising the active agent, the matrix material, and the organic solvent, wherein the feed suspension is at a temperature T1, and directing the feed suspension to a heat exchanger, thereby increasing the temperature of the feed suspension to a temperature T2, wherein T2 is greater than T1, and the spray solution is at a pressure greater than the vapor pressure of the organic solvent at T2, such that the active agent and matrix material are soluble in the organic solvent at T2.

Abstract: Spray drying processes are used to form pharmaceutical compositions comprising a solid amorphous dispersion of a drug and a polymer.

Abstract: A pharmaceutical composition comprises a solid amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer and a lipophilic microphase-forming material. Alternatively, a solid amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer is co-administered with a lipophilic microphase-forming material to an in vivo use environment.

Abstract: Disclosed are compositions including a solid dispersion comprising a dispersion polymer, a basic low-water solubility active, and an anionic counterion, as well as methods of making and using the compositions.

Abstract: The process comprises delivering a spray solution comprising an active agent and a matrix material in an organic solvent to a spray-drying apparatus, atomizing the spray solution into droplets within the spray-drying apparatus to remove at least a portion of the organic solvent from the droplets to form a plurality of particles, and collecting the particles. The spray solution may be formed by forming a feed suspension comprising the active agent, the matrix material, and the organic solvent, wherein the feed suspension is at a temperature T1, and directing the feed suspension to a heat exchanger, thereby increasing the temperature of the feed suspension to a temperature T2, wherein T2 is greater than T1, and the spray solution is at a pressure greater than the vapor pressure of the organic solvent at T2, such that the active agent and matrix material are soluble in the organic solvent at T2.

Abstract: A pharmaceutical composition comprises a solid amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer and a lipophilic microphase-forming material. Alternatively, a solid amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer is co-administered with a lipophilic microphase-forming material to an in vivo use environment.

Abstract: A cassette comprising: a first reservoir arranged to couple to a first actuator for imparting flow to a cell-containing solution in a first direction through a filter; a second reservoir arranged to couple to a second actuator for imparting flow to a cell-containing solution in a second direction through the filter; the filter being in fluid communication with the first and second reservoirs, and when connected to a filtration unit is in further fluid communication to a sample inlet, and a sample outlet; wherein, the cassette is disposable and housed by a connector being removeably adjoinable to the filtration unit, the filtration unit comprising the first and second actuators and one or more valves.

Abstract: Disclosed are processes for forming compositions comprising small domains of an active agent and a matrix material, and methods of using them.

Abstract: Methods for making particulate material include providing a first solution comprising one or more solvents and an active agent, providing a second solution comprising an antisolvent, mixing the first solution with the second solution to form a mixture, atomizing the mixture with a gas to produce droplets, and drying the droplets by directing the droplets into a chamber for removal of the solvent and the antisolvent to produce solid particles. Various apparatuses for producing particulate material in this manner are also provided.

Abstract: Disclosed are compositions including a solid dispersion comprising a dispersion polymer, a basic low-water solubility active, and an anionic counterion, as well as methods of making and using the compositions.

Abstract: The process comprises delivering a spray solution comprising an active agent and a matrix material in an organic solvent to a spray-drying apparatus, atomizing the spray solution into droplets within the spray-drying apparatus to remove at least a portion of the organic solvent from the droplets to form a plurality of particles, and collecting the particles. The spray solution may be formed by forming a feed suspension comprising the active agent, the matrix material, and the organic solvent, wherein the feed suspension is at a temperature T1, and directing the feed suspension to a heat exchanger, thereby increasing the temperature of the feed suspension to a temperature T2, wherein T2 is greater than T1, and the spray solution is at a pressure greater than the vapor pressure of the organic solvent at T2, such that the active agent and matrix material are soluble in the organic solvent at T2.

Abstract: A pharmaceutical composition comprises a solid adsorbate comprising a drug adsorbed onto a substrate and a lipophilic microphase-forming material. The solid adsorbate may also be co-administered with a lipophilic microphase-forming material to an in vivo use environment. The compositions of the present invention enhance the concentration of drug in a use environment.