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 present invention discloses a method for realizing multi-column continuous chromatography design and analysis based on a chromatography model, and a method for realizing multi-column continuous chromatography design and analysis based on an artificial neural network. The method based on the chromatography model includes the following steps: step 101, experimental breakthrough curve fitting: performing fitting using a chromatography model to obtain model parameters; step 102: breakthrough curve prediction: substituting the model parameters into the chromatography model to obtain a breakthrough curve under different operation conditions; step 103, process analysis of continuous chromatography: substituting the predicted breakthrough curve and the continuous chromatography operation parameters into a continuous chromatography model to obtain performance indexes such as process productivity and resin capacity utilization; and step 104, operation space optimization of continuous chromatography: obtaining the operation space of the continuous chromatography design parameters based on a specific separation target. The method based on the artificial neutral network completes the respective steps above by replacing the chromatography model with artificial neural network.

A method and system for solid phase extraction of a compound of interest from a sample matrix using a syringe having a barrel and a plunger, a sorbent for use with the syringe, and a desalting purification column having an end configured to receive liquid from the syringe body.

The present invention advantages over conventional methods and products. In an aspect, a method comprises separating a mixture of allulose, fructose, glucose, and gluco-oligosaccharides, wherein the separating comprises using simulated moving bed chromatography, and recovering allulose at a high purity and yield. In an aspect, the simulated moving bed (“SMB”) chromatography to separate a fraction enriched with allulose from a fraction enriched with fructose and glucose, and to separate a fraction enriched with fructose from a fraction enriched with glucose. In an aspect, the method provides separation of an allulose from a mixture of allulose, fructose, and D-glucose, wherein the mixture is produced from high fructose corn syrup (“HFCS”) when HFCS is contacted with an allulose epimerase. In an aspect, the method produces a high quality allulose product. In an aspect, the fraction enriched with fructose can be recycled to contact the allulose epimerase.

The invention relates to a method for purifying a target substance starting from a fluid to be treated which comprises at least one impurity. The method comprises treatment of a stream of the fluid to be treated using a chromatography step in a first separation unit, collection of a fraction enriched with the target substance in a first tank, and viral inactivation of the fraction enriched with the target substance. The viral inactivation comprises passing the fraction enriched with the target substance through a second separation unit, passing a viral inactivation solution through the second separation unit, mixing, and collecting the mixture in the second tank to obtain a fraction depleted of active virus. The method further comprises treatment of the fraction depleted of active virus using a chromatography step in the second separation unit and collection of a fraction more enriched with the target substance.

A process for the preparation of a carrier-free Ga-68 solution from an irradiated Zn target, systems comprising components used in the process, and compositions comprising Ga-68 prepared by the process. Purification of Ga-68 is carried out by feeding an irradiation target solution comprising Zn-68, Ga-68 and solid target assembly metals into a system comprising three chromatography columns in succession.

Disclosed is a method for preparing a composition comprising factor VIII (FVIII) and von Willebrand factor (vWF), wherein the content of the von Willebrand factor (vWF) can be controlled by mixing the factor VIII (FVIII) with the von Willebrand factor (vWF) at an appropriate ratio after separately purifying the factor VIII (FVIII) and the von Willebrand factor (vWF) from plasma in a single process. The method can prepare and purify a composition comprising factor VIII (FVIII) and a varying content of von Willebrand factor (vWF) without increasing the amount of impurities other than the von Willebrand factor (vWF) compared to a method of purifying factor VIII (FVIII) separately, without significantly increasing the processing time (within 3 hours) compared to a method of purifying factor VIII (FVIII), and without changing the yield of factor VIII (FVIII).

Methods and systems are provided to improve consistency and robustness in chromatography, for example, in operations of multi-column chromatography systems.

A process for purifying a composition comprising water, a target substance, impurities and optionally cells, the process comprising the steps (A) and (B): (A) preparing a liquid feedstock by performing step (Ai) and/or (Aii) on the composition: (Ai) removing at least some of the cells from the composition; (Aii) concentrating the composition by removing water therefrom; and (B) passing the liquid feedstock through an apparatus comprising at least two processing units, each such unit producing a product stream containing purified target substance and optionally a waste stream comprising at least some of the impurities, wherein each unit comprises specified components (i) to (v). The units may be essentially the same except for a device they contain, leading to advantages in terms of simplicity, cost and ease of operation, lower risk of operator error, easier maintenance and lower inventory of spare parts.