Provided are a method of and an apparatus for formulating a multicomponent drug capable of surely making a multicomponent drug meeting criteria for productization with high accuracy into a product. The method and apparatus obtain a chromatogram from an extract or a base of a multicomponent drug, evaluate whether the base meets the criteria for productization based on the obtained chromatogram with high accuracy, and subject the base determined in the high-accuracy evaluating as an accepted one meeting the criteria to dosage form processing, to produce a formulated drug having a given dosage form. The high quality evaluation is realized by performing peak assignment of a target fingerprint obtained from a chromatogram to a reference fingerprint with high accuracy.

A sampling system for collecting periodic composite and/or non-composite samples of vaporized gas during a transfer process from a vaporizer of a cryogenic hydrocarbon liquid including 1) a direct sample pathway to a gas analyzer for instantaneous, real-time vaporized gas analysis, 2) a speed loop pathway for directly collecting fresh vaporized gas samples for subsequent analysis, and 3) a composite sample pathway including a pressurized sample accumulator for collecting a plurality periodically obtained samples of a select volume during the transfer process to create a composite sample of the vaporized gas.

Provided are a method of and an apparatus for formulating a multicomponent drug capable of surely making a multicomponent drug meeting criteria for productization with high accuracy into a product. The method and apparatus obtain a chromatogram from an extract or a base of a multicomponent drug, evaluate whether the base meets the criteria for productization based on the obtained chromatogram with high accuracy, and subject the base determined in the high-accuracy evaluating as an accepted one meeting the criteria to dosage form processing, to produce a formulated drug having a given dosage form. The high quality evaluation is realized by performing peak assignment of a target fingerprint obtained from a chromatogram to a reference fingerprint with high accuracy.

A sampling system for collecting periodic composite and/or non-composite samples of vaporized gas during a transfer process from a vaporizer of a cryogenic hydrocarbon liquid including 1) a direct sample pathway to a gas analyzer for instantaneous, real-time vaporized gas analysis, 2) a speed loop pathway for directly collecting fresh vaporized gas samples for subsequent analysis, and 3) a composite sample pathway including a pressurized sample accumulator for collecting a plurality periodically obtained samples of a select volume during the transfer process to create a composite sample of the vaporized gas.

Provided are a method of and an apparatus for formulating a multicomponent drug capable of surely making a multicomponent drug meeting criteria for productization with high accuracy into a product. The method and apparatus obtain a chromatogram from an extract or a base of a multicomponent drug, evaluate whether the base meets the criteria for productization based on the obtained chromatogram with high accuracy, and subject the base determined in the high-accuracy evaluating as an accepted one meeting the criteria to dosage form processing, to produce a formulated drug having a given dosage-form. The high quality evaluation is realized by using fingerprint area segmentation feature values obtained from a fingerprint formed from a chromatogram and segmented into a plurality of areas.

Provided are a method of and an apparatus for formulating a multicomponent drug capable of surely making a multicomponent drug meeting criteria for productization with high accuracy into a product. The method and apparatus obtain a chromatogram from an extract or a base of a multicomponent drug, evaluate whether the base meets the criteria for productization based on the obtained chromatogram with high accuracy, and subject the base determined in the high-accuracy evaluating as an accepted one meeting the criteria to dosage form processing, to produce a formulated drug having a given dosage-form. The high-accuracy evaluating is realized by selecting with high accuracy one of reference fingerprints to which peaks of a target fingerprint prepared from the chromatogram are assigned.

The disclosure features methods that include obtaining a vibrational spectrum of a solution in a biological manufacturing system, analyzing the vibrational spectrum using a first chemometrics model to determine a value of a first quality attribute associated with the solution, analyzing the vibrational spectrum using a second chemometrics model to determine a value of a second quality attribute associated with the solution, and adjusting at least one parameter of a purification unit of the biological manufacturing system based on at least one of the values of the first and second quality attributes.

The present invention relates to a method for reconstructing events related to a process run in a bioprocess purification system comprising hardware configured to control the events related to the purification of a liquid containing a sample in the bioprocess purification system. The method comprising: recording hardware state S11 related to the process run; recording readings from sensors S12 related to the process run; and synchronizing hardware state S13 with readings from sensors to link the hardware state with the result from the process run. The present invention also related to a method for simulating future events related to a process run in a bioprocess purification system comprising hardware configured to control the events related to the purification of a liquid containing a sample in the bioprocess purification system. The events are controlled by a number of instructions executed consecutively and the method comprising: establishing a current state S21 of the process run; assessing an outcome S23 of each non-executed instructions based on information stored in a data storage medium; and predicting future events S24 based on the current state of the process run and the assessed outcome of the non-executed instructions.

Systems for measuring a product quality attribute of an analyte of a biological sample include a first flow control device, a sample purification device, a second flow control device in fluid communication with first and second sample analyzers, where the first sample analyzer includes a first chromatography column, and a control unit configured so that during operation of the system, the control unit adjusts a configuration of the second flow control device to direct a portion of the biological sample to one of the first and second sample analyzers, and determines a product quality attribute of an analyte of the biological sample based on an analysis of the portion of the biological sample by the one of the first and second sample analyzers.

A chromatography quality control device includes a measurement data acquirer that acquires measurement data obtained as a result of measurement in a chromatograph and stores the measurement data in a storage device, a chromatogram factorizer that retrieves the measurement data from the storage device, dimensionally compresses a chromatogram obtained from the measurement data by factorization and stores component data, the component data obtained by the factorization, in the storage device, and a component data outputter that retrieves the component data from the storage device and outputs the component data to a display device.