A separating column for use with a filling tube to prepare for chromatography is disclosed. The separating column includes an axially movable spring stamp; and a plurality of springs coupled to the stamp. Moreover, the stamp is depressed directly into the column tube during column packing via the filling tube. Additionally, the stamp is fixed in the column tube while maintaining the packing pressure so that the springs are compressed during the packing process and press the stamp permanently and dynamically onto a chromatographic bed.

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 liquid chromatography packing material employing crosslinked polymer particles, wherein the volume average particle size of the crosslinked polymer particles is at least 2 m but not more than 10 m, the amount of fine particles having a particle size of 1 m or less among the crosslinked polymer particles is less than 1% by volume, and the identity coefficient in the particle size distribution is not more than 1.15.

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 method for analysis of related substances in a cyclosporine A preparation is provided. Chromatographic conditions for the method are as follows: a detection wavelength: 210 nm to 230 nm; a column temperature: 50? ? C. to 60? C.; a flow rate: 0.8 mL/min to 1.5 mL/min; a mobile phase A: acetonitrile (0.085% phosphoric acid); a mobile phase B: isopropanol (0.085% phosphoric acid); and a mobile phase C: water (0.1% phosphoric acid).

The method of the present disclosure can well solve problems such as interference of adjuvants and poor separation of many related substances, and also provides an effective means for formulation of quality standards for related substances in such a preparation.

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 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.

A microfluidic bead-packing method includes activating a first micropump to transfer active microbeads through an inlet microchannel from a bead suspension reservoir to an adsorbing channel; packing the microbeads in the adsorbing channel; and activating a second micropump to reverse flow through at least a portion of the inlet microchannel and to transfer a sample fluid through the inlet microchannel from a sample reservoir to the adsorbing channel such that the sample fluid interacts with the packed microbeads.

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.