Abstract: A system and method for capillary electrophoresis are provided for analyzing a macromolecule prepared from a complex liquid mixture. In particular applications, methods and apparatus are provided for separating and analyzing a solution containing a denatured macromolecule by employing a stationary capillary electrophoresis apparatus. An apparatus for capillary electrophoresis includes an inlet chamber and a capillary electrophoresis column. One end of the column is fixed at the interior of the inlet chamber. The column has a length of at least about 20 centimeters. Also included is a liquid source adapted for automatic control. The liquid source supplies a liquid sample through an input valve into the inlet chamber so that the sample is in fluid communication with the end of the column. A method for capillary electrophoresis includes automatically supplying the liquid sample to the apparatus.

Abstract: A system automatically prepares and analyzes a macromolecule prepared from a complex liquid mixture. To prepare the macromolecule, a controller executing executable instructions, such as compiled software or firmware, operates a hydraulic subsystem in response to operational input, which may be interpreted by the executable instructions at run-time. To analyze the prepared macromolecule, an apparatus for capillary electrophoresis includes a liquid source, inlet chamber, capillary electrophoresis column, and controller that may operate under control of executable instructions and operational input in a similar manner. The system may require validation and approval by a regulatory body, such as the FDA. Based on the de-coupled configuration of the executable instructions and operational input, the system can be validated and approved with the executable instructions independent of the operational input, and vice-versa. A method for distributing the system based on this feature is also provided.

Abstract: An apparatus and method for an aseptic fluidic interface between bioprocess systems is provided. The apparatus includes an inlet valve, adapted for automatic control, that is coupled to a biofluid source site. A sampling conduit extends from the inlet valve to an outlet valve. The outlet valve is adapted for automatic control and is coupled to a biofluid process site. A trap is at the sampling conduit. A waste valve, adapted for automatic control, is located at a waste conduit extending from the sampling conduit to a waste site. Also included is a wash fluid source that is coupled to at least one of the inlet or outlet valves. In the method, the sample is automatically directed to the biofluid process site by opening the outlet valve, and closing the waste valve Also included is isolating the biofluid sites by closing the inlet and outlet valves, and opening the waste valve to drain biofluid from the trap to the waste site.

Abstract: A system and method for capillary electrophoresis are provided for analyzing a macromolecule prepared from a complex liquid mixture. In particular applications, methods and apparatus are provided for separating and analyzing a solution containing a denatured macromolecule by employing a stationary capillary electrophoresis apparatus. An apparatus for capillary electrophoresis includes an inlet chamber and a capillary electrophoresis column. One end of the column is fixed at the interior of the inlet chamber. The column has a length of at least about 20 centimeters. Also included is a liquid source adapted for automatic control. The liquid source supplies a liquid sample through an input valve into the inlet chamber so that the sample is in fluid communication with the end of the column. A method for capillary electrophoresis includes automatically supplying the liquid sample to the apparatus.

Abstract: A method for detecting at least one molecular species in a crude sample is disclosed. The method comprises: acquiring a crude sample containing at least one molecular species; separating from the molecular species sample components that have size and masses greater and/or smaller than the molecular species of interest; pre-focusing molecular species in the crude sample within the capillary electrophoresis apparatus one or more times by applying voltage to the capillary for a period of time sufficient to cause electrophoretic migration of at least one molecular species in the sample up to a boundary between a low-electrolyte plug and a high-electrolyte buffer and applying a negative pressure differential to the capillary for a period of time sufficient to cause the pre-focused molecular species to be pushed substantially to its original position; electrophoretically separating the molecular species in the crude sample; and detecting the separated molecular species.

Abstract: An apparatus for preparing a macromolecule sample from a complex liquid mixture includes a hydraulic system adapted for control by an automated controller, comprising a pump and one or more valves. The hydraulic system can be controlled by an automated controller to apply the liquid mixture to one or more filters with a pressure differential across each filter. The filters include a rough filter selected to separate, from a macromolecule in a liquid mixture, at least a portion of one or more rough components in the mixture that are larger than the macromolecule. Further included is a fine filter selected to separate from the macromolecule at least a portion of one or more fine components in the mixture that are smaller than the macromolecule. A method for preparing a macromolecule sample includes automatically acquiring a liquid mixture, the mixture including a macromolecule.