This disclosure provides liquid chromatography tandem mass spectrometer (LC-MS/MS) methods and systems for detecting low levels of pesticides and mycotoxins in a test sample. In the disclosed methods and systems, oxalic acid is added to a mobile phase composition of a reverse phase chromatographic separation column. This addition improves the signal for certain pesticides and mycotoxins by a factor of from 1.5 to 9, improving their detection limits in a variety of test samples.

Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido Asn.sup.A21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.

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.

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 present invention relates to a process for the preparation of Linaclotide by oxidizing linear Linaclotide of formula (II) using combination of air and oxidizing agent followed by purification using RP-HPLC.

The present disclosure relates to, inter alia, a method of quantitating an amount of an antibody molecule from a mixture comprising two or more antibody molecules, comprising separating each of the two or more antibody molecules from the mixture by hydrophobic interaction chromatography high performance liquid chromatography (HIC-HPLC) and quantitating an amount of each antibody molecule, wherein the molecular weight of each antibody molecule is within 15 kDa of any other antibody molecule in the mixture and either each antibody molecule is different from another antibody molecule in the mixture by more than about 0.25 unit on the Kyte & Doolittle hydropathy scale or each of the antibody molecules when nm alone on HIC-HPLC elutes at distinct run time with little overlap from the other antibody molecules in the mixture, or both.

Provided herein, in some embodiments, are methods of purifying low-salt RNA compositions using denaturing oligo-dT chromatography.

The present disclosure relates to methods of modifying complex extracts such that components or mixtures of components are selectively removed or added, thus providing a complex mixture that does not naturally occur with a refined or a tuned therapeutic or nutraceutical effect. In various aspects, the complex extract can be an extract obtained from one or more plants, e.g., an extract obtained from green tea leaves. The present disclosure pertains to compositions obtained by the disclosed methods, nutraceutical compositions comprising same, pharmaceutical compositions comprising same, and methods of treating various conditions, including physiological dysfunctions associated with elevated reactive oxygen species and/or inflammatory molecule, e.g., TNFα, expression using same. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present disclosure.

In various aspects, the present disclosure pertains to methods of performing a sample enrichment procedure, which comprise: adding a sample fluid that comprises at least one phospholipid and at least one target analyte to a sorbent that comprises a hydrophobic component and a cation exchange component, thereby resulting in sorbent with bound phospholipid and bound target analyte; adding an aqueous solution comprising an acidic compound and a salt; adding an organic solution to the sorbent thereby desorbing at least a portion of the bound phospholipid from the sorbent; and adding an elution solution to the sorbent, thereby desorbing at least a portion of the bound target analyte from the sorbent and forming a solution of the target analyte in the elution solution. In other aspects, the present disclosure pertains to kits, which may be used in conjunction with such methods.

The present invention relates generally to processes for production of heavily glycosylated recombinant proteins (e.g., mucins and mucin-like proteins, such as lubricin), the processes comprising culturing mammalian cells capable of producing a glycoprotein in a liquid medium in a system comprising one or more bioreactors, concentrating and purifying and formulating the glycoprotein, the purification comprising one or more steps of chromatography, an endonuclease step, and at least one step of viral inactivation. In certain aspects the invention relates to pharmaceutical compositions comprising purified recombinant human lubiricin, and methods of treating a subject in need thereof.