The present invention relates to methods for controlling chromatographic processes in real-time via mass measurement utilizing a variable pathlength spectrophotometer.

In certain embodiments, the present invention provides a method of measuring the level of hydrophobicity of a chromatographic resin. In certain embodiments, the present invention provides a method of selecting a chromatographic resin condition for purifying a protein of interest from a mixture, wherein the protein of interest has low or no aggregation formation during chromatography. In certain embodiments, the present invention provides a method of selecting a chromatographic resin from a plurality of chromatographic resins for purifying a protein of interest from a mixture, wherein the protein of interest has low or no aggregation formation during chromatography.

Provided is a complex composition, of which positional isomers are minimized by using a N-terminus of an immunoglobulin Fc region as a binding site when the immunoglobulin Fc region is used as a carrier. Also provided are a protein complex which is prepared by N-terminal-specific binding of immunoglobulin Fc region, thereby prolonging blood half-life of the physiologically active polypeptide, maintaining in vivo potency at a high level, and having no risk of immune responses, a preparation method thereof, and a pharmaceutical composition including the same for improving in vivo duration and stability of the physiologically active polypeptide. The protein complex may be usefully applied to the development of long-acting formulations of various physiologically active polypeptide drugs.

The present invention provides for a fusion protein comprising (1) a bacterial microcompartment (BMC) shell protein comprising one or more subunit, and (2) a first component of a specific-binding pair, operably linked to the BMC shell protein such that the first component faces (i) a lumen (inside) side, or (ii) outside of a BMC shell formed incorporating the fusion protein and the fusion protein does not disrupt or prevent the folding of the BMC shell protein or the ability of the BMC shell protein to integrate with other BMC shell proteins into a BMC shell; wherein the first component is capable of forming a stable or irreversible interaction with a second component of the specific-binding pair.

The present disclosure provides “all-in-one” cartridges which contain necessary reagents and materials to isolate/preconcentrate targeted proteins from blood plasma and ionize them for mass spectrometry detection. In another configuration, the cartridges include proteolytic enzymes to digest the proteins into smaller peptides in addition to preconcentration and ionization for mass spectrometry detection.

Disclosed are products and methods for monitoring Klotho protein levels and for stabilizing Klotho protein in a mammalian blood sample, especially at room temperature or without freezing, for a period of time. Methods of detecting and quantifying Klotho protein levels, particularly endogenous and/or exogenous soluble alpha Klotho protein levels, methods of diagnosing Klotho protein deficiency, and methods of increasing Klotho protein levels or production, particularly endogenous and/or exogenous soluble alpha Klotho protein level(s), expression, or production, in a mammalian subject, and products useful in performing the same, including diagnostic kits and compositions for treating Klotho protein deficiency, are disclosed. Compositions are configured or formulated to augment natural soluble alpha Klotho protein production, attenuate Klotho protein damage or degradation, and/or supplement Klotho protein levels with exogenous, recombinant protein. Treatment methods and uses include administration of the compositions to human or non-human mammalian subjects.

A chromatography medium includes a porous matrix and nonporous globules bound on the inner and outer surfaces of the porous matrix. The average radius of the microglobules is not more than 30% of the average pore diameter of the porous matrix. The chromatography medium can be used in affinity chromatography. A method for preparing the chromatography medium may include providing a porous starting matrix, providing a polymerization solution, and initiating polymerization of the polymerization solution in the presence of the porous starting matrix to form insoluble nonporous microglobules that are bound to the inner and outer surfaces of the porous starting matrix.

There is provided a chromatography system comprising a first valve in fluid connection to a first chromatography column and/or a second valve; the second valve in fluid connection to a second chromatography column and the first valve; wherein the first valve and the second valve are operable to provide: a mode that selectively allows a fluid to flow from the first chromatography column to the second chromatography column; and one or more modes that selectively allows the fluid to bypass the first chromatography column and/or the second chromatography column. Also disclosed is a method of capturing and/or purifying a target from a sample thereof. In one embodiment, an acidic protein, alpha-1 anti-trypsin (A1AT), is purified by a tandem column configuration using anion exchange chromatography, whereby a first chromatography column is added in between the sample pump and an injection valve, or replaced the sample loop of AKTA system.

A method for clarifying a bioprocess fluid comprising particles suspending in a cell culture fluid is provided. The method includes providing a cell culture suspended in an unclarified bioprocess fluid in a bioreactor. A chromatography affinity resin is added directly to the unclarified bioprocess fluid. The chromatography affinity resin binds a biological target. The unclarified bioprocess fluid with the bound biological target is passed into an assisted gravity settler.

Siderocalin-metal chelator combinations that bind metallic radioisotopes used in nuclear medicine with high affinity are described. The high affinity siderocalin-metal chelator combinations include a number of chelator backbone arrangements with functional groups that coordinate with metals. The siderocalin-metal chelator combinations can be used to deliver radionuclides for imaging and therapeutic purposes.