Abstract: A segmented multi-use automated assay cartridge for conducting a fluid assay includes a plurality of microfluidic assay circuits having the fluid flow channels configured to perform an assay on a sample, each circuit is configured to receive fluids for performing the assay (e.g., sample, buffer, detection analyte, dye, etc.) and each circuit is also configured to dispense waste fluid of the assay to a corresponding fluidic waste channel. A waste tower is configured to received waste fluid from the fluidic waste channel and to dispense the waste fluid to a common waste reservoir, whereby the assay waste fluid from each circuit comingles in the common waste reservoir and does not comingle with waste fluid from other circuits in the device in the fluidic waste channel, which allows multiple different assays to be run by the cartridge at different times.

Abstract: A system includes a housing, a cartridge retainer disposed within the housing, a detection assembly disposed within the housing, and a reagent tray holder movably disposed in the housing. The cartridge retainer configured to receive a capillary cartridge having a capillary. The detection assembly includes at least one emitter, a first detector, and a second detector. The detection assembly is configured to transition between a first configuration, in which the first detector detects a first output of the at least one emitter, and a second configuration, in which the second detector detects a second output of the at least one emitter. The reagent tray holder is configured to move relative to the cartridge retainer to place the capillary of the capillary cartridge in fluid communication with a reagent volume.

Abstract: A method and apparatus are provided for performing capillary isoelectric focusing followed by mobilization of the focused zones by induced hydrodynamic flow or chemical mobilization. These two dimensions of separation are integrated with real-time whole-channel electrophoresis detection and automatic sample injection to achieve a separation resolution superior to that obtainable using known orthogonal capillary two dimensional arrangements.

Abstract: Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.

Abstract: An apparatus includes a body portion that defines a reservoir and a set of substantially flexible capillaries. The set of substantially flexible capillaries are fixedly coupled to the body portion and in fluid communication with the reservoir. A connector is configured to be coupled to the body portion to be in fluid communication with the reservoir and the set of substantially flexible capillaries. The connector is further configured to be coupled to a vacuum source. The apparatus is arranged such that at least a part of the body portion is electrically conductive. Methods for separating and detecting an analyte from a biological sample with the apparatus are also provided. For example, methods for separating and detecting one or more proteins from a cellular lysate or a purified protein are also provided.

Abstract: Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.

Abstract: An apparatus includes a body portion that defines a reservoir and a set of substantially flexible capillaries. The set of substantially flexible capillaries are fixedly coupled to the body portion and in fluid communication with the reservoir. A connector is configured to be coupled to the body portion to be in fluid communication with the reservoir and the set of substantially flexible capillaries. The connector is further configured to be coupled to a vacuum source. The apparatus is arranged such that at least a part of the body portion is electrically conductive. Methods for separating and detecting an analyte from a biological sample with the apparatus are also provided. For example, methods for separating and detecting one or more proteins from a cellular lysate or a purified protein are also provided.

Abstract: Methods for detecting one or more analytes, such as a protein, in a fluid path are provided. The methods include resolving, immobilizing and detecting one or more analytes in a fluid path, such as a capillary. Also included are devices and kits for performing such assays.

Abstract: An apparatus and method are disclosed for the precise selection and extraction of a selected analyte in a focused zone produced by isoelectric focusing performed in micro-channels. A cross-channel microfluidic device comprises a sample mixture introduction and separation channel and an extraction channel, which are in fluid communication with each other at a point of intersection. Means are provided for selectively moving the pattern of separated zones following cIEF to the intersection point, and means are provided for applying an extraction pressure to direct a single zone containing a selected analyte into and then out of the extraction channel for collection.

Abstract: A method and a particle analyzer are provided for determining a particle size distribution of a liquid sample including particles of a lower size range, particles of an intermediate size range, and particles of an upper size range. A dark-field image frame is captured in which the particles of the lower size range and the particles of the intermediate size range are resolved, and a bright-field image frame is captured in which the particles of the intermediate size range and the particles of the upper size range are resolved. Absolute sizes of the particles of the intermediate size range and the particles of the upper size range are determined from the bright-field image frame. Calibrated sizes of the particles of the lower size range are determined from the dark-field image frame by using the particles of the intermediate size range as internal calibration standards.

Abstract: Methods and apparatus are provided to resolve analytes within a fluid path using isoelectric focusing, gel electrophoresis, or other separation means. Materials within the fluid path that are compatible with these separation means are used to attach resolved analytes to the wall of the fluid path. Attachment results from a triggerable event such as photoactivation, thermal activation, or chemical activation. In accordance with a further aspect of the present invention, the material in the capillary may also be disrupted, by either the triggerable event or a subsequent event such as melting or photocleavage. Thus, an open lumen or porous structure may be created within the fluid path, allowing unbound analyte materials to be washed from the fluid path, and detection agents to be washed into the fluid path. The separation-compatible materials may be polymerizable monomers, gels, entangled polymers or other materials.

Abstract: An apparatus includes a body portion that defines a reservoir and a set of substantially flexible capillaries. The set of substantially flexible capillaries are fixedly coupled to the body portion and in fluid communication with the reservoir. A connector is configured to be coupled to the body portion to be in fluid communication with the reservoir and the set of substantially flexible capillaries. The connector is further configured to be coupled to a vacuum source. The apparatus is arranged such that at least a part of the body portion is electrically conductive. Methods for separating and detecting an analyte from a biological sample with the apparatus are also provided. For example, methods for separating and detecting one or more proteins from a cellular lysate or a purified protein are also provided.

Abstract: A method and a particle analyzer are provided for determining a particle size distribution of a liquid sample including particles of a lower size range, particles of an intermediate size range, and particles of an upper size range. A dark-field image frame is captured in which the particles of the lower size range and the particles of the intermediate size range are resolved, and a bright-field image frame is captured in which the particles of the intermediate size range and the particles of the upper size range are resolved. Absolute sizes of the particles of the intermediate size range and the particles of the upper size range are determined from the bright-field image frame. Calibrated sizes of the particles of the lower size range are determined from the dark-field image frame by using the particles of the intermediate size range as internal calibration standards.

Abstract: Electrophoresis Compositions, methods and kits useful for, among other things, detecting, quantifying and/or characterizing analytes are provided. The compositions are useful as electrophoresis standards for determine the isoelectric point and molecular weight of an analyte. The electrophoresis standards generally comprise at least one label moiety and one or more reactive moieties that when activated attach the standard to a substrate.

Abstract: An automated assay system is described with stations for placement of materials to be used in an assay of materials inside capillaries and an automated gripper for manipulating capillaries. The system includes a separation and immobilization station where reactions inside the capillaries take place and a detector station where photoemissions from the capillary reactions are detected. The photoemissions from the capillaries may be displayed as line graphs or in columns of a pseudo-gel image resembling the familiar Western gel blot. An automated control system has a user interface by which an operator can select a run protocol and define the locations of samples and reagents to be used in the protocol run: Following the setup the control system will cause the automated system to execute the protocol, then display the results in a selected display format.

Abstract: A method and a particle analyzer are provided for determining a particle size distribution of a liquid sample including particles of a lower size range, particles of an intermediate size range, and particles of an upper size range. A dark-field image frame is captured in which the particles of the lower size range and the particles of the intermediate size range are resolved, and a bright-field image frame is captured in which the particles of the intermediate size range and the particles of the upper size range are resolved. Absolute sizes of the particles of the intermediate size range and the particles of the upper size range are determined from the bright-field image frame. Calibrated sizes of the particles of the lower size range are determined from the dark-field image frame by using the particles of the intermediate size range as internal calibration standards.

Abstract: Provided herein are IEF focusing methods for determining the number of drug molecules present in at least one antibody-drug conjugate (ADC) species subpopulation. In one embodiment, the method comprises performing free solution isoelectric focusing on a sample comprising at least one ADC species, to obtain a focused sample. The absorbance of the sample at two different wavelengths is then measured, for example, over a range of pI values. Absorbance values at the two different wavelengths are compared at at least one corresponding pI value, where the at least one corresponding pI value is the pI of the ADC subpopulation. The number of drug molecules in the at least one ADC species subpopulation is then determined based on the comparison. The methods provided herein can also be used to determine the number of specific binding pair members bound to its target specific binding pair member.

Abstract: An automated assay system is described with stations for placement of materials to be used in an assay of materials inside capillaries and an automated gripper for manipulating capillaries. The system includes a separation and immobilization station where reactions inside the capillaries take place and a detector station where photoemissions from the capillary reactions are detected. The photoemissions from the capillaries may be displayed as line graphs or in columns of a pseudo-gel image resembling the familiar Western gel blot. An automated control system has a user interface by which an operator can select a run protocol and define the locations of samples and reagents to be used in the protocol run: Following the setup the control system will cause the automated system to execute the protocol, then display the results in a selected display format.

Abstract: An automated assay system is described with stations for placement of materials to be used in an assay of materials inside capillaries and an automated gripper for manipulating capillaries. The system includes a separation and immobilization station where reactions inside the capillaries take place and a detector station where photoemissions from the capillary reactions are detected. The photoemissions from the capillaries may be displayed as line graphs or in columns of a pseudo-gel image resembling the familiar Western gel blot. An automated control system has a user interface by which an operator can select a run protocol and define the locations of samples and reagents to be used in the protocol run. Following the setup the control system will cause the automated system to execute the protocol, then display the results in a selected display format.

Abstract: An automated assay system is described with stations for placement of materials to be used in an assay of materials inside capillaries and an automated gripper for manipulating capillaries. The system includes a separation and immobilization station where reactions inside the capillaries take place and a detector station where photoemissions from the capillary reactions are detected. The photoemissions from the capillaries may be displayed as line graphs or in columns of a pseudo-gel image resembling the familiar Western gel blot. An automated control system has a user interface by which an operator can select a run protocol and define the locations of samples and reagents to be used in the protocol run. Following the setup the control system will cause the automated system to execute the protocol, then display the results in a selected display format.