Detection and identification of microbial species uses liquid chromatography as a bulk filtration process for rapid isolation and collection of microbial RNA from a biological specimen. In various embodiments, gene sequencing of microbial RNA molecules from a biological specimen is enhanced by obtaining and then preparing the biological specimen as a test sample for liquid chromatography that is used to bulk filter microbial RNA molecules from a mixture of RNA molecules in the test sample to isolate and collect the microbial RNA molecules in two or more fraction outputs, wherein at least one of the two or more fraction outputs is a fraction within a void volume of the liquid chromatography, preparing one or more fraction outputs for gene sequencing, including the fraction output that is within the void volume, and conducting gene sequencing on the one or more prepared outputs to detect microbial RNA from the biological specimen.

The current application provides a rapid and simple method for measuring residual pDADMAC in a sample containing a recombinant protein of interest based on the combination of use of reversed-phase hydrophobic interaction HPLC and charged aerosol detection.

The present disclosure relates to an apparatus and a method for purifying BNNT and purified BNNT, more specifically to an apparatus and a method for purifying BNNT, which allow separation of pure BNNT from synthesized BNNT wherein various impurities are included with high purification efficiency and separation of BNNT based on length, and purified BNNT. The method for purifying BNNT according to the present disclosure is characterized in that pure BNNT is separated from synthesized BNNT based on length by inputting a mobile phase including synthesized BNNT into a column chromatography device.

Provided is a method of producing monophosphoryl lipid A (MPLA). According to the method, MPLA may be produced with high purity and high purity by using a bacterium producing MPLA.

The present disclosure is directed to a method of operating a chromatography column. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is determined based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. The height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value. If during routine column monitoring, an adverse trend in HETP is observed or the control limits are exceeded, the eluate product quality, column process performance, and/or impurity removal data should be evaluated to ensure product quality for the identified batch. Should any of the product quality or column performance fail the criteria set, appropriate corrective action, such as conditioning, repacking or replacing the column, and qualification should be performed prior to release for further use.

A method of collecting a nucleic acid from a sample containing a nucleic acid using a support of aluminum oxide having a surface where a water-soluble neutral polymer is adsorbed, the method including steps a to c: step a: a step of bringing the support into contact with the sample containing a nucleic acid to adsorb the nucleic acid on the support; step b: a step of bringing the support on which the nucleic acid is adsorbed into contact with a solution A containing 1 mM or more and 40 mM or less of a chelating agent; and step c: after the step b, a step of bringing the support on which the nucleic acid is adsorbed into contact with a solution B containing 50 mM or more of a chelating agent to elute the nucleic acid.

The present disclosure is directed to methods for performing size exclusion chromatography. Embodiments of the present disclosure feature methods for improving separations of proteinaceous analytes in size exclusion chromatography, for example, by using low concentrations of amino acids or derivatives thereof in the mobile phase.

The present disclosure is directed to a method of operating a chromatography column in methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody STELARA® (ustekinumab), specific pharmaceutical compositions of the antibodies, and antigen binding fragments thereof. This method involves collecting column outlet signal and accumulated flow parameters at two or more intervals of at least one mobile phase transition front during operation of the chromatography column comprising column packing. A model gamma cumulative distribution curve is determined based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. The height equivalent theoretical plate (HETP) value is calculated for the at least one mobile phase transition front using parameters of the model gamma cumulative distribution curve and the quality of the chromatography column packing is assessed based on the calculated HETP value. If during routine column monitoring, an adverse trend in HETP is observed or the control limits are exceeded, the eluate product quality, column process performance, and/or impurity removal data should be evaluated to ensure product quality for the identified batch. Should any of the product quality or column performance fail the criteria set, appropriate corrective action, such as conditioning, repacking or replacing the column, and qualification should be performed prior to release for further use.

The present invention provides methods for isolating an active polypeptide or immunoconjugate by purification of a solution containing both the active polypeptide or immunoconjugate and an acidic variant thereof, such as a deamidated variant, using anion exchange chromatography. The present invention also provides compositions, formulations, and unit dosage forms comprising the purified polypeptide or immunoconjugate.

A solvent delivery system for a liquid chromatography system may include a first gradient proportioning valve in fluidic communication with a first plurality of sources of solvent and producing therefrom a first low-pressure gradient stream. The solvent delivery system may further include a second gradient proportioning valve in direct fluidic communication with an inlet of the first gradient proportioning valve and with a second plurality of sources of solvent, the second gradient proportioning valve producing a second low-pressure gradient stream from the second plurality of sources of solvent, wherein one solvent source of the first plurality of sources of solvent used by the first gradient proportioning valve to produce the first low-pressure gradient stream comprises the second low-pressure gradient stream. The solvent delivery system may also include a first pump in direct fluidic communication with the first gradient proportioning valve to receive and pressurize the first low-pressure gradient stream.