Disclosed are methods and devices for the optimization of virus removal from solutions. A method of filtering a process fluid comprising a product includes allowing some of the process fluid to flow from a first reservoir to a viral filter; adding a chase fluid to the process fluid in the first reservoir to form a composite fluid; and allowing the composite fluid to flow from the first reservoir to the viral filter to produce eluent. In some embodiments, flow of fluid across the viral filter is sufficient to avoid significant impairment to viral removal until a preselected event, occurs. In some embodiments, flow of fluid from the first reservoir across the viral filter is maintained in the absence of an interruption or slowing of flow of duration or magnitude sufficient to impair viral removal to a level below a log-reduction value of the viral filter.

Disclosed are methods and devices for the optimization of virus removal from solutions. A method of filtering a process fluid comprising a product includes allowing some of the process fluid to flow from a first reservoir to a viral filter; adding a chase fluid to the process fluid in the first reservoir to form a composite fluid; and allowing the composite fluid to flow from the first reservoir to the viral filter to produce eluent. In some embodiments, flow of fluid across the viral filter is sufficient to avoid significant impairment to viral removal until a preselected event, occurs. In some embodiments, flow of fluid from the first reservoir across the viral filter is maintained in the absence of an interruption or slowing of flow of duration or magnitude sufficient to impair viral removal to a level below a log-reduction value of the viral filter.

A response factor that is a signal strength ratio with respect to a reference compound for various compounds is previously stored in a response factor storage (22). When an operator instructs to estimate an analysis limit value, a measurement unit (1) performs GC-MS analysis on a sample containing the reference compound a plurality of times under control of an analysis controller (3). A signal strength calculator (23) obtains a signal strength value of the reference compound based on an analysis result of the measurement unit (1), a relative strength calculator (24) calculates a relative standard deviation from the plurality of measured signal strength values, and calculates the relative standard deviation of a target compound from the response factor of the target compound read from the response factor storage (22). An analysis limit value estimator (25) estimates a limit of detection (LOD) and the like from the relative standard deviation of the target compound by a known method, and displays the LOD on a display (6). Consequently, the analysis limit value can simply be obtained without actually measuring the target compound.

A response factor that is a signal strength ratio with respect to a reference compound for various compounds is previously stored in a response factor storage (22). When an operator instructs to estimate an analysis limit value, a measurement unit (1) performs GC-MS analysis on a sample containing the reference compound a plurality of times under control of an analysis controller (3). A signal strength calculator (23) obtains a signal strength value of the reference compound based on an analysis result of the measurement unit (1), a relative strength calculator (24) calculates a relative standard deviation from the plurality of measured signal strength values, and calculates the relative standard deviation of a target compound from the response factor of the target compound read from the response factor storage (22). An analysis limit value estimator (25) estimates a limit of detection (LOD) and the like from the relative standard deviation of the target compound by a known method, and displays the LOD on a display (6). Consequently, the analysis limit value can simply be obtained without actually measuring the target compound.

In an LC/MS analysis of a sample containing various compounds, additive supply pumps 164A and 164B in a post-column adding unit 16 draw and supply different kinds of additives A and B from containers 163A and 163B, respectively. The additives are mixed into an eluate through T-joints 162 and 161. A preferable combination of the additives is the combination of DMSO which produces the effect of gathering charge states and 2-propanol which produces the effect of promoting atomization or vaporization of droplets. By mixing the two additives into the eluate while mixing them at an appropriate flow-rate ratio according to a previously determined flow-rate program, the ionization efficiency can be nearly optimized for each compound during the process of generating ions by spraying electrically charged droplets of the eluate from an ESI spray 21. Consequently, the detection sensitivity becomes higher than conventional levels.

In an LC/MS analysis of a sample containing various compounds, additive supply pumps 164A and 164B in a post-column adding unit 16 draw and supply different kinds of additives A and B from containers 163A and 163B, respectively. The additives are mixed into an eluate through T-joints 162 and 161. A preferable combination of the additives is the combination of DMSO which produces the effect of gathering charge states and 2-propanol which produces the effect of promoting atomization or vaporization of droplets. By mixing the two additives into the eluate while mixing them at an appropriate flow-rate ratio according to a previously determined flow-rate program, the ionization efficiency can be nearly optimized for each compound during the process of generating ions by spraying electrically charged droplets of the eluate from an ESI spray 21. Consequently, the detection sensitivity becomes higher than conventional levels.

The present disclosure provides systems and methods that allow users to quickly determine titer and remove hold steps by determining a first concentration using slope spectroscopy, depleting the fluid of the expressed protein by selective adsorption, and determining a second concentration using slope spectroscopy. Further, the systems and methods of the present disclosure allows the user to forgo the use of a bioanalyzer or HPLC.

The present disclosure provides systems and methods that allow users to quickly determine titer and remove hold steps by determining a first concentration using slope spectroscopy, depleting the fluid of the expressed protein by selective adsorption, and determining a second concentration using slope spectroscopy. Further, the systems and methods of the present disclosure allows the user to forgo the use of a bioanalyzer or HPLC.

An analysis device of the present invention is provided with a sample introduction unit that introduces a sample into a mass spectroscope; a sample condensation unit that treats the sample introduced into the device; a detection unit that analyzes the sample treated by a treatment unit; and a control unit that controls the sample introduction unit, the sample condensation unit, and the detection unit. The sample introduction unit includes a sample introduction valve, and the sample condensation unit includes an elution valve and a cleaning valve, and the cleaning valve is disposed between the sample introduction valve and the elution valve.

An analysis device of the present invention is provided with a sample introduction unit that introduces a sample into a mass spectroscope; a sample condensation unit that treats the sample introduced into the device; a detection unit that analyzes the sample treated by a treatment unit; and a control unit that controls the sample introduction unit, the sample condensation unit, and the detection unit. The sample introduction unit includes a sample introduction valve, and the sample condensation unit includes an elution valve and a cleaning valve, and the cleaning valve is disposed between the sample introduction valve and the elution valve.