Abstract: The present disclosure relates to methods for preparing extracellular vesicles (EVs). In particular, the methods provided herein comprise contacting a sample, which comprises EVs and one or more impurities, with a depth filter, wherein the depth filter is selected from a LA media grade depth filter, a SP media grade depth filter, or both. In some aspects, the methods further comprise one or more chromatography steps. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.

Abstract: The present disclosure relates to extracellular vesicles (e.g., exosomes) comprising a biologically active molecule covalently linked to the extracellular vesicle via an optimized linker and an anchoring moiety, which may be useful as an agent for the prophylaxis or treatment of cancer or other diseases. Also provided herein are methods for producing the extracellular vesicles and methods for using the extracellular vesicles to treat diseases or disorders.

Abstract: The present disclosure relates to extracellular vesicles (EVs), e.g., exosomes, which can be rapidly modified to comprise an antigen of interest, and the uses of such EVs as vaccines for the treatment of wide range of diseases or disorders. Also provided herein are methods for preparing and manufacturing such EVs for use as vaccines.

Abstract: The present disclosure relates to multistep chromatographic methods for preparing extracellular vesicles (EVs). The methods were demonstrated to be effective in preparing high-quality EVs in a large scale. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.

Abstract: The present disclosure relates to multistep chromatographic methods for preparing extracellular vesicles (EVs). The methods were demonstrated to be effective in preparing high quality EVs in a large scale. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.

Abstract: Provided herein are methods of preparing EVs, e.g., exosomes, associated with or encapsulated various cyclic dinucleotides, including STING agonists. Also provided herein are methods of loading EVs, e.g., exosomes, with various cyclic dinucleotides, including STING agonists.

Abstract: The present disclosure relates to multistep chromatographic methods for preparing extracellular vesicles (EVs). The methods were demonstrated to be effective in preparing highquality EVs in a large scale. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.

Abstract: The present disclosure relates to high-throughput screening methods for identifying one or more chromatography operational parameters (e.g., binding parameters) and/or reagents for purifying EVs (e.g., exosomes) from a sample using chromatography. Also disclosed herein are methods for improving one or more aspects of EV (e.g., exosome) purification, e.g., improving EV yield, increasing EV ligand density, and/or reducing impurity recovery.

Abstract: The present disclosure relates to extracellular vesicles, e.g., exosomes, comprising an AAV and a scaffold protein. In some aspects, the AAV is in the lumen of the extracellular vesicle. In some aspects, the AAV is associated with the luminal surface of the extracellular vesicle. In some aspects, the AAV is associated with the exterior surface of the extracellular vesicle. Also provided herein are methods for producing the exosomes and methods for using the exosomes to treat and/or prevent diseases or disorders.

Abstract: The present invention provides an automated system and method for maintaining compaction, and therefore increased efficiency, of a media bed within a chromatography column. In the preferred embodiment, an adjustment assembly is slidingly engaged inside one end of the column such that it can be moved along the column's major axis. When idle, the force exerted on this end is equal to the compression on the media. When the column is actively processing chromatographic fluid, this exerted force can be expressed as the sum of the compression on the media, and the force of the fluid being processed. This total force and the fluid pressure are monitored using a load cell and a pressure sensor respectively. The compression force operating on the media bed is then computed based on these measurements and compared to the optimal value. The position of the adjustment assembly within the column is then modified in response to changes in the measured compression force.

Abstract: The present invention provides an automated system and method for packing chromatography columns. In one embodiment, the system first determines the type of media that is present in the column, and uses this information to generate an automated procedure to pack the specific media type. In a second embodiment, the media type is made known to the system, such as via input from the operator. The system then uses this information, in the same manner as in the first embodiment, to generate an automated procedure to pack the specific media type. Finally, in a third embodiment, parameters such as column height and rate of compression are made known to the system, such as via input from the operator. The system then packs the column in accordance with these supplied parameters.

Abstract: The present invention provides an automated system and method for maintaining compaction, and therefore increased efficiency, of a media bed within a chromatography column. In the preferred embodiment, an adjustment assembly is slidingly engaged inside one end of the column such that it can be moved along the column's major axis. When idle, the force exerted on this end is equal to the compression on the media. When the column is actively processing chromatographic fluid, this exerted force can be expressed as the sum of the compression on the media, and the force of the fluid being processed. This total force and the fluid pressure are monitored using a load cell and a pressure sensor respectively. The compression force operating on the media bed is then computed based on these measurements and compared to the optimal value. The position of the adjustment assembly within the column is then modified in response to changes in the measured compression force.

Abstract: The present invention provides an automated system and method for maintaining compaction, and therefore increased efficiency, of a media bed within a chromatography column. In the preferred embodiment, an adjustment assembly is slidingly engaged inside one end of the column such that it can be moved along the column's major axis. When idle, the force exerted on this end is equal to the compression on the media. When the column is actively processing chromatographic fluid, this exerted force can be expressed as the sum of the compression on the media, and the force of the fluid being processed. This total force and the fluid pressure are monitored using a load cell and a pressure sensor respectively. The compression force operating on the media bed is then computed based on these measurements and compared to the optimal value. The position of the adjustment assembly within the column is then modified in response to changes in the measured compression force.

Abstract: The present invention provides an automated system and method for packing chromatography columns. In one embodiment, the system first determines the type of media that is present in the column, and uses this information to generate an automated procedure to pack the specific media type. In a second embodiment, the media type is made known to the system, such as via input from the operator. The system then uses this information, in the same manner as in the first embodiment, to generate an automated procedure to pack the specific media type. Finally, in a third embodiment, parameters such as column height and rate of compression are made known to the system, such as via input from the operator. The system then packs the column in accordance with these supplied parameters.

Abstract: The present invention provides an automated system and method for packing chromatography columns. In one embodiment, the system first determines the type of media that is present in the column, and uses this information to generate an automated procedure to pack the specific media type. In a second embodiment, the media type is made known to the system, such as via input from the operator. The system then uses this information, in the same manner as in the first embodiment, to generate an automated procedure to pack the specific media type. Finally, in a third embodiment, parameters such as column height and rate of compression are made known to the system, such as via input from the operator. The system then packs the column in accordance with these supplied parameters.

Abstract: The present invention provides an automated system and method for maintaining compaction, and therefore increased efficiency, of a media bed within a chromatography column. In the preferred embodiment, an adjustment assembly is slidingly engaged inside one end of the column such that it can be moved along the column's major axis. When idle, the force exerted on this end is equal to the compression on the media. When the column is actively processing chromatographic fluid, this exerted force can be expressed as the sum of the compression on the media, and the force of the fluid being processed. This total force and the fluid pressure are monitored using a load cell and a pressure sensor respectively. The compression force operating on the media bed is then computed based on these measurements and compared to the optimal value. The position of the adjustment assembly within the column is then modified in response to changes in the measured compression force.

Abstract: The present invention provides an automated system and method for maintaining compaction, and therefore increased efficiency, of a media bed within a chromatography column. In the preferred embodiment, an adjustment assembly is slidingly engaged inside one end of the column such that it can be moved along the column's major axis. When idle, the force exerted on this end is equal to the compression on the media. When the column is actively processing chromatographic fluid, this exerted force can be expressed as the sum of the compression on the media, and the force of the fluid being processed. This total force and the fluid pressure are monitored using a load cell and a pressure sensor respectively. The compression force operating on the media bed is then computed based on these measurements and compared to the optimal value. The position of the adjustment assembly within the column is then modified in response to changes in the measured compression force.

Abstract: The present invention provides an automated system and method for packing chromatography columns. In one embodiment, the system first determines the type of media that is present in the column, and uses this information to generate an automated procedure to pack the specific media type. In a second embodiment, the media type is made known to the system, such as via input from the operator. The system then uses this information, in the same manner as in the first embodiment, to generate an automated procedure to pack the specific media type. Finally, in a third embodiment, parameters such as column height and rate of compression are made known to the system, such as via input from the operator. The system then packs the column in accordance with these supplied parameters.

Abstract: The present invention provides an automated system and method for maintaining compaction, and therefore increased efficiency, of a media bed within a chromatography column. In the preferred embodiment, an adjustment assembly is slidingly engaged inside one end of the column such that it can be moved along the column's major axis. When idle, the force exerted on this end is equal to the compression on the media. When the column is actively processing chromatographic fluid, this exerted force can be expressed as the sum of the compression on the media, and the force of the fluid being processed. This total force and the fluid pressure are monitored using a load cell and a pressure sensor respectively. The compression force operating on the media bed is then computed based on these measurements and compared to the optimal value. The position of the adjustment assembly within the column is then modified in response to changes in the measured compression force.

Abstract: The present invention is a flow distributor and integral bed support for a chromatography column. The flow distributor has an outlet extending through it and a bottom face across which is secured a bed support. The bottom face has a series of ribs extending radially outward from a center portion of the face. The bed support is secured to the flow distributor about its outer periphery and this amount of available surface area of the flow distributor and/or face that is used to secure the bed support is less than about 10%. A distribution disk is arranged over the inlet and extends across from about 1 to about 30% of the flow distributor's surface area, ending just short of the inner edge of the ribs closest to the center point of the flow distributor face. This disk is mounted on two or more legs so as to be of substantially the same height as the ribs. The disk projects the fluid flow in a 360° radial distribution without any noticeable partitioning.