The present disclosure is directed at the selection and design of columns for liquid chromatography including liquid chromatography devices and systems and corresponding methods of operation, particularly in the field of high pressure liquid chromatography (HPLC).

The invention discloses a bioprocess chromatography column comprising: a) a bed chamber delimited by at least one side wall, a first bed support screen and a second bed support screen; b) a first end wall, secured to or integral with the side wall(s), with a first port fluidically connected via a first distributor to the first bed support screen; c) a second end wall, secured to or integral with the side wall(s), with a second port fluidically connected via a second distributor to the second bed support screen; d) a packing port in a wall; and e) an internal bracing, secured to, or integral with, at least one of the end walls and extending into the bed chamber.

A method for separating at least one target compound from a feed solution is provided. The method includes filling a bioprocess package with a chromatography resin. The bioprocess package includes a 2D flexible container comprising an interior compartment, a height having an upper half and a lower half, an inlet and an outlet, the inlet and the outlet being disposed on the same half of the 2D flexible container, the channel-forming feature being configured to maintain a fluid flow path that fluidly connects the interior compartment of the flexible container with the outlet. The method further includes flowing a feed solution into the bioprocess package to contact the chromatography resin such that substantially all of the at least one target compound binds to the chromatography resin, washing the chromatography resin in the bioprocess package, and eluting the chromatography resin.

This disclosure provides chromatography columns that are packed with incompressible media such as ceramic hydroxyapatite particles, which exhibit high separation performance that is robust to transportation and multiple uses. The columns can be made by applying axial compression using rigid bodies, such as porous frits and/or flow regulators.

A packing assembly for forming a packed-bed for a chromatography device is described herein. The packing assembly includes a bottom plate and a first top plate. The first top plate has a top plate hole centrally positioned therein. The packing assembly also includes a middle plate. The middle plate has a middle plate hole centrally positioned therein. The middle plate hole is aligned with the top plate hole when the packing assembly is in an assembled state. The packing assembly also includes a second top plate. The second top plate has a protrusion extending outwardly. At least a portion of the protrusion has a same size and a same shape as the top plate hole to be received in the top plate hole when the packing assembly is in a packing state. Methods of packing chromatography media in a packing assembly and assembling a chromatography device are also described herein.

A gas chromatographic (GC) column using a zwitterionic compound and methods of use thereof are disclosed herein. The volatile free acids were observed to strongly retain on these zwitterionic compounds-based columns with excellent peak symmetry. By carefully tuning the structures of these zwitterionic compounds, different selectivity toward volatile free acids was demonstrated. These stationary phases possess a wide working range with thermal stabilities at higher temperatures.

The invention relates to containers or bags for chromatographic media and methods of packing chromatography columns using such containers. The bags may be used for storing and/or transporting chromatographic media and can be inserted directly into the chamber of a chromatography column in readiness for use.

A method of operating a chromatography column is described. 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.

A method of operating a chromatography column is described for use in methods of manufacture for producing anti-IL-12/IL-23p40 antibodies, e.g., the anti-IL-12/IL-23p40 antibody STELARA? (ustekinumab). 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.

A method of operating a chromatography column is described for use in methods of manufacture for producing anti-TNF antibodies, e.g., the anti-TNF? antibody SIMPONI? (golimumab). 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 calculated based on the collected column outlet signal and accumulated flow parameters for the at least one mobile phase transition front. A 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.