The present disclosure relates to a chromatographic stationary phase having a uniform polymer density, and related methods. In particular, the present disclosure relates to a method of forming a uniformly dense stationary phase inside a chromatography column.

A method for producing a chromatography carrier, including providing a solid phase support, where the solid phase support provided is formed of porous particles on which a ligand has or has not been immobilized, and subjecting the solid phase support to sieve classification. A coefficient of variation of a volume particle size distribution of the porous particles when a ligand has been immobilized is adjusted to 1% to 22%, and a ratio (d1/d50) of volume cumulative 1% particle size d1 to volume cumulative 50% particle size d50 in terms of the porous particles is adjusted to 0.55 to 1.0.

A system and method of applied radial technology chromatography using a plurality of beads is disclosed, with each bead comprising one or more pores therein having a diameter of about 250 ? to about 5000 ?, and each bead having an average radius between about 100 ?m to about 250 ?m. Also disclosed are processes for selecting beads for use in a radial flow chromatography column, and for purifying an unclarified feed stream using a radial flow chromatography column.

A column mainly comprises a tube, a plug, a first filter, a second filter, a stopper, and a connector. The tube mainly comprises a bottomed cylindrical storage part, and a cylindrical bottom-side connection part connected to a bottom of the storage part. The storage part and the bottom-side connection part are coaxially provided. The plug mainly comprises an outer pipe coaxially provided, and an inner pipe provided on an inner side of the outer pipe. The first filter and the second filter each are such a filter as not to enable the filler to pass. The stopper mainly comprises a stopper gripping part, and a stopper insertion part. The connector mainly comprises a connector gripping part and a connector insertion part.

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.

The invention discloses a method for packing a plurality of uniform chromatography columns, comprising the steps of: a) providing a plurality of chromatography columns; b) providing a plurality of chromatography resin aliquots; c) packing the chromatography resin aliquots in the chromatography columns to provide a plurality of packed chromatography columns; and d) subjecting the packed chromatography columns to repeated mechanical impacts to provide a plurality of uniform chromatography columns.

A system and method of applied radial technology chromatography using a plurality of beads is disclosed, with each bead comprising one or more pores therein having a diameter of about 250 ? to about 5000 ?, and each bead having an average radius between about 100 ?m to about 250 ?m. Also disclosed are processes for selecting beads for use in a radial flow chromatography column, and for purifying an unclarified feed stream using a radial flow chromatography column.

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.

A synthetic polymeric porous medium with a core-shell(s) hierarchical layer structure and has an essentially homogeneous porous structure from inside to outside of the medium, whose core and shell(s) are covalently modified with distinct chemical functional groups or same functional group with different density. Here the methodologies for resin syntheses and core-shell(s) modifications and liquid chromatographic applications of the newly developed resins in the field of analysis and purification of Tween surfactants, virus-like particles (VLP)/vaccines/viral vectors/viruses, antibody, and mRNA are disclosed.

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.