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 present disclosure is directed to methods of characterizing a system containing a chromatographic column. The methods can include introducing a sample comprising a positive control and a negative control to the system containing a chromatographic column, wherein the positive control is a sensitive probe that interacts with the system and the negative control is substantially non-interacting with the system; after passing the sample through the chromatographic column, detecting the positive control and the negative control; and determining system suitability by comparing the amount of detected positive control to negative control. In some embodiments, determining system suitability (e.g., inertness of sample to the system) is accomplished by determining a ratio of detected positive control to negative control.

A process for removing Pb.sup.2+, Hg.sup.2+, K.sup.+ and NH.sub.4.sup.+ toxins from bodily fluids is disclosed. The process involves contacting the bodily fluid with an ion exchange composition to remove the metal toxins in the bodily fluid, including blood and gastrointestinal fluid. Alternatively, blood can be contacted with a dialysis solution which is then contacted with the ion exchange composition. The ion exchange compositions are represented by the following empirical formula:

A.sup.r+.sub.pM.sup.s+.sub.1-xM′.sup.t+.sub.xSi.sub.nO.sub.m

A composition comprising the above ion exchange compositions in combination with bodily fluids or dialysis solution is also disclosed. The ion exchange compositions may be supported by porous networks of biocompatible polymers such as carbohydrates or proteins.

A method, system, and apparatus for chromatography comprises a chromatographic system can include a column packed with mesoporous graphitized carbon (MGC). The MGC serves as an ideal stationary phase and facilitates the efficient isomeric separation of compounds such as permethylated glycans with unprecedented 10 mm long column. The column is anticipated to be an efficient and economical replacement for nanoflow PGC column which was phased out by the manufacturer due to poor performance and lack of reproducibility.

A particulate plug for removing a preservative from a solution, suspension, or emulsion comprising a drug is presented. The plug comprises microparticles of a hydrophobic polymer/fatty acid blend. The microparticles of hydrophobic polymer/fatty acid blend selectively absorb preservative allowing the drug to remain in solution for delivery.

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.

A process for transglucosylation of steviol glycosides. A sweetener composition comprises at least 95% total glycosylated steviol glycosides.

The invention relates to a method for providing an aseptic chromatography column, said method comprising the steps of: pre-sterilize an empty chromatography column; pre-sterilize a chromatography medium; introducing the pre-sterilized chromatography medium into the pre-sterilized chromatography column using aseptic equipment, thereby providing an aseptic chromatography column comprising chromatography medium.

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.

One object of the present invention is to prevent non-specific metal coordination adsorption of solutes in a sample, while achieving high pressure resistance through the use of a metal column hardware column, and to prevent non-specific adsorption of basic solutes and non-specific hydrophobic adsorption of highly hydrophobic solutes. As a means for achieving the foregoing, proposed is column hardware 1 for liquid chromatography, in which a first membrane 41 containing SiO.sub.2 as a main component is provided on a metallic liquid-contact portion by mobile phase 3 of the column hardware 1 for liquid chromatography, and a second membrane 42 in which silanol groups on the SiO.sub.2 surface are alkylsilylated is provided on a surface 411 of the first membrane 41.