The invention relates to containers or bags for chromatographic media and methods of packing chromatography columns using such containers. The bags may be used for storing and/or transporting chromatographic media and can be inserted directly into the chamber of a chromatography column in readiness for

The present invention provides methods for cleaning or regenerating a chromatography material for reuse. The methods of the invention can be used for cleaning or regenerating ion exchange chromatography columns for reuse in the large-scale manufacture of multiple polypeptide products where the ion exchange chromatography column in used in overload mode.

The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.

The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.

Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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.

Provided are methods for determining the apolipoprotein E (ApoE) phenotype in a sample by mass spectrometry; wherein the ApoE allele(s) present in the sample is determined from the identity of the ions detected by mass spectrometry. In another aspect, provided herein are methods for diagnosis or prognosis of Alzheimer's disease or dementia.

The invention discloses a method for sanitization of a bioprocess chro matography column, comprising the steps of: a) providing a bioprocess chromatogra phy column with a packed bed of separation resin particles and a movable adapter, b) with the adapter in contact with the packed bed, conveying a sanitization fluid through the packed bed to a column outlet; c) raising the adapter to provide a gap between the packed bed and the adapter, d) lowering the adapter to close the gap; and e) conveying an equilibration liquid through the packed bed to a column outlet.

The invention discloses a method for sanitization of a bioprocess chro matography column, comprising the steps of: a) providing a bioprocess chromatogra phy column with a packed bed of separation resin particles and a movable adapter, b) with the adapter in contact with the packed bed, conveying a sanitization fluid through the packed bed to a column outlet; c) raising the adapter to provide a gap between the packed bed and the adapter, d) lowering the adapter to close the gap; and e) conveying an equilibration liquid through the packed bed to a column outlet.

Techniques are described for accelerating thermal equilibrium in a chromatographic column. An apparatus comprises a chromatography column, and a plurality of temperature control units in thermal contact with the chromatography column. A method of performing liquid chromatography comprises setting an inlet of a chromatography column to a first temperature using a first temperature control unit in thermal contact with said inlet, setting an outlet of the chromatography column to a second temperature using a second temperature control unit in thermal contact with the outlet, wherein the first temperature is less than the second temperature; and injecting a sample into a liquid stream that flows through the chromatography column after the inlet is set at the first temperature and the outlet is at the second temperature.

Techniques are described for accelerating thermal equilibrium in a chromatographic column. An apparatus comprises a chromatography column, and a plurality of temperature control units in thermal contact with the chromatography column. A method of performing liquid chromatography comprises setting an inlet of a chromatography column to a first temperature using a first temperature control unit in thermal contact with said inlet, setting an outlet of the chromatography column to a second temperature using a second temperature control unit in thermal contact with the outlet, wherein the first temperature is less than the second temperature; and injecting a sample into a liquid stream that flows through the chromatography column after the inlet is set at the first temperature and the outlet is at the second temperature.