A two-step chromatography purification scheme is described which selectively captures and isolates the genome-containing rAAV vector particles from the clarified, concentrated supernatant of a rAAV production cell culture. The process utilizes an affinity capture method performed at a high salt concentration followed by an anion exchange resin method performed at high pH to provide rAAV vector particles which are substantially free of rAAV intermediates.

The present invention relates to a method of separating and analyzing a mixture of oligonucleotides, including performing liquid chromatography using a column packed with a packing material obtained by fixing a diol to a surface of each of porous particles formed of a crosslinked organic polymer. According to this method, the oligonucleotides can be separated and analyzed with higher sensitivity compared to cases where columns having silica gel as a base material are used. In addition, the column can be washed with an alkaline solution.

A two-step chromatography purification scheme is described which selectively captures and isolates the genome-containing rAAV vector particles from the clarified, concentrated supernatant of a rAAV production cell culture. The process utilizes an affinity capture method performed at a high salt concentration followed by an anion exchange resin method performed at high pH to provide rAAV vector particles which are substantially free of rAAV intermediates.

A process for providing a mono-PEGylated protein composition is provided. The process is particularly suitable for providing mono-PEGylated erythropoietin composition. The process comprises subjecting a mixture comprising non-PEGylated, mono-PEGylated and oligo-PEGylated to a hydrophobic interaction chromatography process.

A two-step chromatography purification scheme is described which selectively captures and isolates the genome-containing rAAV vector particles from the clarified, concentrated supernatant of a rAAV production cell culture. The process utilizes an affinity capture method performed at a high salt concentration followed by an anion exchange resin method performed at high pH to provide rAAV vector particles which are substantially free of rAAV intermediates.

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 enhancing a mass spectral signal is disclosed. The method can include contacting a sample to a separation column under conditions that permit sample components to bind to the substrate; applying a first mobile gradient to the separation column, wherein the first mobile phase gradient comprises trifluoroacetic acid (TFA) and a small molecule additive (e.g., an amino acid) or formic acid (FA) and a small molecule additive (e.g., an amino acid); applying a second mobile gradient to the separation column, wherein the second mobile phase gradient comprises TFA in acetonitrile (ACN) and a small molecule additive (e.g., an amino acid) or formic acid (FA) in ACN and a small molecule additive (e.g., an amino acid); and performing mass spectrometric analysis on eluted sample components.

The present disclosure provides devices, systems, kits and methods useful for quantitation of biomolecules such as intact proteins and nucleic acids.

The present disclosure provides methods for purifying a recombinant AAV (rAAV) vector from a solution by anion-exchange chromatography (AEX) to produce an eluate enriched for full capsids and depleted of empty capsids.

A method of producing substantially pure rare earth elements (REEs) from a mixture, including the steps of dissolving a mixture containing REEs in a strong acid to result in a dissolved mixture of metal ions, including that of REEs, capturing metal ions of REEs in a first set of chromatographic columns comprising strong acid cation exchange resins, washing said first set of chromatographic columns with a salt solution to remove non-adsorbing metal ions, eluting metal ions of REES from said first set of chromatographic columns with a first ligand solution to result in a solution of enriched metal ions of REEs, loading said solution of enriched metal ions of REEs onto a second set of chromatographic columns, and eluting bound metal ions of REEs stepwise from said second set of chromatographic columns using a second ligand solution to afford a substantially pure REE. The second set of chromatographic columns comprises hydrous polyvalent metal oxide selected from the group consisting of TiO.sub.2, ZrO.sub.2, or SnO.sub.2. The ligand of the second ligand solution coordinates with said hydrous polyvalent metal oxide.