The invention provides for mammalian cells capable of producing recombinant CTLA4-Ig and variants thereof. The invention also provides for compositions comprising CTLA4-Ig and formulations thereof. The invention further provides for methods for mass-producing CTLA4-Ig from mammalian cells capable of producing this recombinant protein, and for purifying the CTLA4-Ig.

The invention provides for mammalian cells capable of producing recombinant CTLA4-Ig and variants thereof. The invention also provides for compositions comprising CTLA4-Ig and formulations thereof. The invention further provides for methods for mass-producing CTLA4-Ig from mammalian cells capable of producing this recombinant protein, and for purifying the CTLA4-Ig.

The present invention provides novel chromatographic materials, e.g., for chromatographic separations, processes for its preparation and separations devices containing the chromatographic material; separations devices, chromatographic columns and kits comprising the same; and methods for the preparation thereof. The chromatographic materials of the invention are high purity chromatographic materials comprising a chromatographic surface wherein the chromatographic surface comprises a hydrophobic surface group and one or more ionizable modifier.

The present invention provides methods for purifying a polypeptide from a composition comprising the polypeptide and at least one contaminant by overloading a chromatography material and eluting the product.

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.

Provided is a method for producing and/or purifying measles virus (MV) particles from a sample, the method comprising in sequential order the following steps loading a sample containing MV particles and one or more impurities onto a stationary phase material for carrying out flow-through chromatography to bind at least a fraction of the impurities contained in the sample and to produce a flow-through comprising at least a fraction of the MV particles contained in the sample; carrying out filtration, preferably ultrafiltration, and obtaining a retentate having an increased MV titer relative to the MV titer comprised in the flow-through. Further provided is a system for producing and/or purifying MV particles, comprising at least one bioreactor; a clarification unit, preferably a dead end filter unit, downstream to the bioreactor; a flow through chromatography unit downstream to the clarification unit; and a filtration unit, downstream to the flow through chromatography unit.

A separation medium for use in the separation of analytes from a feed stream containing suspended solids, processes of separation using the separation medium, and the use of the separation medium to separate analytes from a feed stream containing suspended solids. The separation medium is provided as a hydrogel having a structure whose surfaces are defined by a triply periodic minimal surface, the hydrogel comprising at least one ligand that binds at least one target analyte.

The present invention provides a functionalised polymeric chromatography medium, prepared by a process which comprises (i) providing a substrate formed of one or more polymer nanofibres, (ii) grafting one or more neutral polymer chains from the substrate, and (iii) contacting the grafted product with a reagent which functionalises the product of step (ii) as a chromatography medium, wherein step (ii) comprises reacting a plurality of compounds of formula and/or its enantiomers, and/or its derivatives of formula (I) and/or enantiomers and/or diastereomers thereof: with one or more functional groups present on the nanofibre substrate, wherein R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 may be the same or different, and are chosen from H, halogen, C.sub.1-C.sub.4 alkyl, or C.sub.1-C.sub.4 alkoxy provided that at least one of R.sub.1, R.sub.2, R.sub.3, R.sub.4 or R.sub.5 is not hydrogen. ##STR00001##

The present invention provides a method for hydrophobization of a hydrophilic material, the method including introducing a hydrophobic group into a hydroxyl group (—OH group) on a surface of the hydrophilic material. A method for hydrophobization of a hydrophilic material, the method comprising reacting a hydrophilic material to be hydrophobized with a hydrophobic group-containing silylating agent in presence of an amino acid as a reaction accelerator, to introduce a hydrophobic group-containing silyl group to a surface of the hydrophilic material. A hydrophobized silica gel column filler is produced by using the method. Further, a hydrophobized silica gel column is produced by filling a column with the hydrophobized silica gel column filler.

Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.