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.

The present disclosure relates to multistep chromatographic methods for preparing extracellular vesicles (EVs). The methods were demonstrated to be effective in preparing highquality EVs in a large scale. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.

There is provided a sorbent for removing metabolic waste products from a dialysis liquid, the sorbent comprising a layer of immobilized uremic toxin-treating enzyme particles intermixed with cation exchange particles.

A method and an apparatus suitable for a continuous chromatography process which only needs three separation columns, and a two-step process containing two chromatographic steps, in which the first chromatographic step (capture) is performed alternating and sequentially on two separation columns, the second chromatographic step (polishing) is performed, also sequentially, on the third column.

The present invention relates to a process for purifying C1-esterase inhibitor (C1-Inh), and more in particular a Cl-Inh concentrate.

Stabilized indicator compositions, and systems and methods using the same are described. In embodiments the stabilized indicator compositions include a solvent, an indicator, a stabilizer for the indicator, and optionally a buffer. In embodiments the indicator is or includes N, N-diethyl-p-phenylene diamine (DPD). Systems and methods utilizing the stabilized indicator composition to determine an amount of at least one constituent in a test sample (e.g., water) are also described. In embodiments, the systems and methods remove the stabilizer from the stabilized indicator composition to produce a fluid flow containing un stabilized indicator, which is then combined with a fluid from a sample source to form a test sample for analysis.

A method for purification of a sulfatase using metal chelating chromatography without using tags such as His-tag, etc. is disclosed. An embodiment provides a method for purifying a sulfatase including the steps of: (a) providing a sulfatase-containing solution comprising one or a plurality of impurities; (b) performing a first chromatographic separation of the sulfatase-containing solution using a metal affinity chromatography resin; (c) performing a second chromatographic separation using a cation exchange chromatography resin; and (d) performing a final chromatographic separation using an anion exchange chromatography resin, wherein the impurities are removed thereby.

A method for purification of a sulfatase using metal chelating chromatography without using tags such as His-tag, etc. is disclosed. An embodiment provides a method for purifying a sulfatase including the steps of: (a) providing a sulfatase-containing solution comprising one or a plurality of impurities; (b) performing a first chromatographic separation of the sulfatase-containing solution using a metal affinity chromatography resin; (c) performing a second chromatographic separation using a cation exchange chromatography resin; and (d) performing a final chromatographic separation using an anion exchange chromatography resin, wherein the impurities are removed thereby.

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 production system for removing impurities from a taurine mother liquor and recovering the taurine mother liquor. The system can be used in an ethylene oxide production process for taurine and the treatment of the last mother liquor of taurine. The system includes, consecutively, an anion resin adsorption device for adsorbing the anions of taurine and sodium isethionate, and an ammonia mixing and desalination device. A feed port of the anion resin adsorption device is operatively connected to receive the last mother liquor of taurine generated in the ethylene oxide taurine production process, and the anion resin adsorption device includes an anion exchange resin column. The ammonia mixing and desalination device includes an ammonia mixing reaction tank, a sealed filtering device, and a circulation path for returning filtrate to the ammonia mixing reaction tank.