A method and a slurry tank system for transferring chromatography media slurry from a slurry tank (3) to a chromatography column (9), said method comprising monitoring the content of slurry in the slurry tank (3) during the transferring and controlling the transferring of the slurry to the column (9) in dependence of the content of slurry in the slurry tank (3).

A method of making and loading a chromatography column includes selecting a column tube having an appropriate elasticity, and inner diameter and length, selecting appropriately sized flow distributors, a second flow distributor having a diameter that is larger than the inner diameter of the tube, permanently securing a first flow distributor to a first end of the tube, loading packing medium into the tube, inserting the second flow distributor into a second end of the tube to drive the second flow distributor into the tube to form a sealed chamber within the tube, adjusting the longitudinal position of the second flow distributor within the tube by applying a force to the second flow distributor until it reaches a desired location within the tube, and/or forcing liquid into the chamber to move the second flow distributor and permanently securing the properly positioned second flow distributor within the tube.

The invention relates to a chromatography column frame comprising at least two legs, a support arrangement connected to said at least two legs, and a holder means connected to said support arrangement. Said holder means is arranged to releasably hold an adaptor rod of a chromatography column, so that the adaptor rod is prevented to move in a horizontal direction and so the adaptor rod is allowed to move in a vertical direction. The invention also relates to method of conducting maintenance on and packing of a chromatography column.

The disclosure provides systems and methods useful for predicting or detecting a malfunction in a chromatography process in real-time. In some embodiments, the disclosure provides systems and methods for detecting an atypical profile in a process chromatogram in ion-exchange chromatography of a biologic product.

A sandwich suppressor in an ion chromatography system in which loosely packed ion exchange resin of low density is disposed in the central sample stream flow channel. Also, a method of using the suppressor is described.

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 invention relates to a chromatography column frame comprising at least two legs, a support arrangement connected to said at least two legs, and a holder means connected to said support arrangement. Said holder means is arranged to releasably hold an adaptor rod of a chromatography column, so that the adaptor rod is prevented to move in a horizontal direction and so the adaptor rod is allowed to move in a vertical direction. The invention also relates to method of conducting maintenance on and packing of a chromatography column.

A chromatography column frame comprising at least two legs, a support arrangement connected to said at least two legs, and a holder connected to said support arrangement. Said holder is arranged to releasably hold an adaptor rod of a chromatography column, so that the adaptor rod is prevented to move in a horizontal direction and so the adaptor rod is allowed to move in a vertical direction.

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 relates to the field of chromatographic sample separation that includes liquid chromatography and solid phase extraction and, in particular, it relates to material and the synthesis of material for use as a stationary phase in chromatographic sample separation. The invention further relates to uses of the material, in particular in the separation of hydrophilic and hydrophobic peptides, non-glycosylated and N-linked glycosylated peptides, deamidated and oxidized peptides. The invention also relates to chromatographic columns and solid phase extraction columns containing the material as a stationary phase.