The subject technology is directed to a CO.sub.2-based chromatography system and method for rapid determination of the levels and/or the presence or absence of polymer additives (PAs) leachable or extractable from packing materials or implantable medical devices.

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.

In one aspect, disclosed herein is a method for determining sulfate concentration in a sample, comprising: a) providing a liquid sample comprising urea and at least one impurity; b) concentrating the liquid sample under conditions effective to reduce the liquid volume; c) forming a dilute sample solution by diluting the concentrated liquid sample of step b) in water; and d) analyzing the dilute sample solution of step c) with ion chromatography to determine if a concentration of sulfate is present in the provided liquid sample of step a); wherein the analyzing of step d) is capable of determining the presence of a sulfate concentration present in an amount less than about 1 ppm.

The subject technology is directed to a CO.sub.2-based chromatography system and method for rapid determination of the levels and/or the presence or absence of polymer additives (PAs) leachable or extractable from packing materials or implantable medical devices.

A process analytic device includes an input to receive a sample of interest and an analytic detector operably coupled to receive the sample of interest. An analytic output is provided relative to the sample of interest. A plurality of heat pipes is thermally coupled to the analytic detector.

An exemplary method for assessing performance of an instance of a chemical process having a series of consecutive phases includes: obtaining data related to the instance of the chemical process; and evaluating, based on the data related to the instance of the chemical process, the performance of the instance of the chemical process using a plurality of performance thresholds, wherein the plurality of performance thresholds is obtained by training a hierarchical model based on one or more historical instances of the chemical process, and wherein the hierarchical model includes: a plurality of batch-evolution models (BEMs) at a first level of a hierarchy; a plurality of batch-level models (BLMs) at a second level above the first level of the hierarchy; and an overall performance model at a third level at a third level above the second level of the hierarchy.

The present disclosure is related to the six isomer structures (OBI-821-1990-V1A, OBI-821-1990-V1B, OBI-821-1990-V2A, OBI-821-1990-V2B, OBI-821-1858-A, and OBI-821-1858-B) of isolated OBI-821 adjuvant and the method for evaluating the quality thereof. The method of the present disclosure adopts hydrophilic interaction liquid chromatography (HILIC) and reverse phase high performance liquid chromatography (RP-HPLC) either alone or in tandem and is able to separate the isomers of OBI-821 adjuvant in the consequent chromatography. Accordingly, the quality of OBI-821 adjuvant can be further evaluated.

A method for monitoring a chromatograph used to control production of a chemical product. The method involves sampling a chemical mixture of chemical components used during the production to form the chemical product, measuring the composition of the sample with a chromatograph and adjusting the amount of the chemical components based on the measured composition. The method also involves measuring actual parameters of the sample with at least one gauge, determining expected parameters of the sample based on the measured composition and the measured actual parameters using an equation-of-state, and detecting a fault in the chromatograph by comparing the expected parameters with the actual parameters.

A system and method are disclosed for analyzing samples, which includes a spectrometry system for detecting components of a sample; a gas chromatography column for separating the components of a sample; a first sample unit for receiving a first sample from a sample source; and a second sample unit for receiving a second sample from a sample source. Each sample loop unit allows independent processing of samples in preparation for analysis.

The disclosure is directed to a system and method for control of at least one bioreactor, other cell cultivation-related equipment, and systems containing any combination of these in a plant. For example, a Plant-Wide Control System (PWCS) or a Process Control System (PCS) may be divided into three main components: hardware (including operating systems, such as a controller communicating with one or more servers of a network associated with the PWCS, (2) software (such as a control module) for performing control, and (3) one or more instrument control loops, which may be used by the software to maintain certain process values. Moreover, a Height Equivalent of a Theoretical Plate (HETP) value and an asymmetry factor may be determined based on real-time analysis on a chromatography column, using PWCS components.