The present invention relates to a method for estimating performance of a bioprocess material when used in a bioprocess system. The bioprocess material comprising at least two ingredients, each having data properties. The method comprises: i) obtaining (81) the data properties for the at least two ingredients used to produce the bioprocess material; ii) defining (82) procedures to process the at least two ingredients; iii) processing (83) the at least two ingredients according to the defined process parameters to obtain at least a product; iv) measuring (84) data properties of each product, v) calculating (85) data properties of each product based on the measured data properties of each product and/obtain or data properties from the at least two ingredients, and vi)if the product is the bioprocess material, processing (88) the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or vii) if the product is not the bioprocess material, treating the product as an intermediate material and repeating (87) steps iii)-vi) with each product as one of the at least two ingredients.

A chromatography system has an associated system volume and a sample dispersion volume. The chromatography system comprises a pump pumping a flow of gradient, a sample manager for introducing a sample into the flow of gradient, and a valve manager fluidically coupled to the pump and to the sample manager. The valve manager includes at least one valve. A first valve of the at least one valve has a plurality of ports including an inlet port that receives the flow of gradient from the pump and an outlet port through which the flow of gradient exits the first valve. The first valve has at least two different, automatically selectable positions. A first position of the at least two different automatically selectable positions operating to change one of the system and sample dispersion volumes of the chromatography system when the first valve is automatically switched into the first position.

Where an abnormal state is detected, an abnormality notification screen to that effect is displayed on a display unit. The abnormality notification screen is non-displayed in a case where hold of the abnormal state is selected in a state where the abnormality notification screen is displayed on the display unit. Where a warning icon is displayed on the display unit to indicate the detection of the abnormal state and the warning icon is selected, the abnormality notification screen is redisplayed on the display unit. The abnormality notification screen is not redisplayed on the display unit until the warning icon is selected after the abnormal state is held and the abnormality notification screen becomes non-displayed. Accordingly, the abnormal state can be confirmed by the warning icon being selected when necessary without the work that is performed by a worker being interrupted by redisplay of the abnormality notification screen.

Technologies are described related to determining conditions for the purification of proteins. In some implementations, models can be generated that predict yield and purity for various chromatographic techniques at a number of pH levels and salt concentrations. Training data used to produce the models can be obtained by running chromatography columns using stationary phase materials of different chromatographic techniques at various combinations of pH levels and salt concentrations. In additional implementations, the training data can be obtained by analyzing solutions included in a subset of wells of a multi-well plate, where the subset of wells are associated with particular salt concentrations and pH values for a particular stationary phase material. Further, the models can be used to determine optimized conditions for the purification of various proteins based on maximizing yield and purity, while minimizing cost.

There is provided a method and a corresponding system for determining binding capacities of a chromatography column. The method includes detecting a feed signal representative of the composition of a feed material provided to the inlet of the column. The method further includes detecting an effluent signal representative of the composition of the effluent from the column. The method further includes using the feed signal and the effluent signal to determine binding capacities of the column.

Provided is a chromatography system including a usage information storage device, a column usage information holding part, and a usage information managing part. The usage information storage device is provided corresponding to the analytical column incorporated in the chromatography system and is configured to keep usage information for each corresponding analytical column. The column usage information holding part is provided separately from the analytical column and is configured to keep usage information for each of the analytical columns which may be incorporated in the chromatography system. The usage information managing part is configured to update, at a timing when an analysis process of separating a sample injected into the analysis channel using the analytical column is executed, the usage information kept by the usage information storage device and the usage information kept by the column usage information holding part in association with the analytical column to latest usage information.

The present invention relates to method of using spectroscopy for real time measuring of concentration of desired product and using measured data for monitoring and control of chromatography. It develops a method and system for measuring real-time concentration of clarified harvest and that of flow through of loading step of the chromatography and using measured data for determining breakthrough in real-time. The two modes of operation are used viz. first mode (Part A) uses a single near infrared spectroscopy (NIR) flow cell prior to the continuous chromatography column to ensure optimal loading in each cycle based on dynamic binding capacity studies carried out previously with the desired Protein A resin and second mode (Part B) uses two near infrared spectroscopy (NIR) flow cells, one before and one after the column, to detect the breakthrough curve (from 1% breakthrough onwards).

The present invention provides a gas chromatography system (GC) including a GC column configured for a chromatographic separation of a sample comprising one or more analytes, a GC detector connected to the exit of the GC column, and a controller connected to the GC system. The controller is configured to generate a simulated chromatographic separation using a chromatographic model that calculates at least one chromatographic parameter of the analyzed sample. The controller further configured to execute a chromatographic separation of the sample and execute chromatographic performance monitoring that includes a comparison of at least one chromatographic parameter to the simulated chromatographic separation and/or reference chromatographic separation, determine if at least one chromatographic parameter has fallen outside of a performance control limit and/or predict if the chromatographic parameter will fall outside the performance control limit, and perform an automated GC troubleshooting procedure to determine the cause of the performance issue.

Systems, methods, and devices for detecting leaks in chromatography systems are disclosed. The leak detection system includes a sealable compartment disposed to surround at least one component of a chromatography system. The detector is in communication, e.g., fluid communication, with an interior of the sealable compartment and configured to detect the leak by various mean including the presence of liquid or the presence of vapor, or both within the sealable compartment.

A liquid chromatography monitoring system comprises a computer or electronic controller comprising computer-readable instructions operable to: (a) draw a fluid into a syringe pump; (b) configure a valve so as to fluidically couple the pump to either a fluidic pathway through a fluidic system or to a plug that prevents fluid flow; (c) cause the syringe pump to progressively compress the fluid therein or expel the fluid to the fluidic pathway, while measuring a pressure of the fluid; (d) determine a profile of the variation of the measured pressure; (e) compare the determined profile to an expected profile that depends upon the fluid; and (f) provide a notification of a sub-optimal operating condition or malfunction if the determined profile varies from the expected profile by greater than a predetermined tolerance.