The present invention relates to a method for purifying a target product in a flow-through chromatography system comprises at least a first column loaded with feed material from a feed source. The at least first column is purged after binding of impurities and wherein the outlet of purged material from the column is subsequently passed to the feed source.

Embodiments of the present disclosure are directed to methods for preparing a target polypeptide from a mixture including the target polypeptide. The method may include contacting the mixture to a hydrophobic interaction chromatography (HIC) apparatus including multiple chromatographic zones. The method may further include passing the target polypeptide through the outlets of at least a first zone and a second zone of the HIC apparatus. A residence time for the mixture including the target polypeptide in a first zone may be approximately the same as a residence time of one or more mobile phases in the second zone.

Embodiments of the present disclosure are directed to methods for preparing a target polypeptide from a mixture including the target polypeptide. The method may include contacting the mixture to a hydrophobic interaction chromatography (HIC) apparatus including multiple chromatographic zones. The method may further include passing the target polypeptide through the outlets of at least a first zone and a second zone of the HIC apparatus. A residence time for the mixture including the target polypeptide in a first zone may be approximately the same as a residence time of one or more mobile phases in the second zone.

Provided herein are methods of processing a fluid that include the use of one or both of a circuit system including a tangential flow filtration (TFF) unit and a circuit system including a tangential flow virus filtration (TFVF) unit. Also provided are integrated and continuous processes for manufacturing a therapeutic protein drug substance that include a step of processing a fluid including the recombinant therapeutic protein using any of the methods provided herein.

Methods for optimizing operating binding capacity for a multiple column chromatography (MCC) process are disclosed.

The present invention describes a method to remove metals present in a mixture comprising one or more organic amines comprising the step of contacting the mixture with a silica-polyethyleneimine adsorbent.

Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

The present disclosure relates to methods and systems for the continuous production of recombinant proteins. In particular embodiments, the disclosure relates to methods and systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins.

A parallel assembly of chromatography column modules, the assembly having one common assembly inlet and one common assembly outlet, each column module comprising a bed space filled with chromatography medium and each column module comprises integrated fluid conduits which when the column module is connected with other column modules are adapted to connect the bed space of the column module with the assembly inlet and the assembly outlet, wherein the total length and/or volume of the fluid conduit from the assembly inlet to one bed space together with the length and/or volume of the fluid conduit from the same bed space to the assembly outlet is substantially the same for all bed spaces and modules installed in the parallel assembly.

A cell lysis buffer separation apparatus for preparing a polypeptide, and a system and the application thereof. The system comprises a polypeptide enrichment module, wherein the polypeptide enrichment module comprises a cell lysis buffer separation apparatus, and the cell lysis buffer separation apparatus comprises a multi-filtration device and a waste discharge pipeline, the waste discharge pipeline being connected to the multi-filtration device. The system can perform multi-filtration treatment on a lysis buffer. Therefore, the yield of target protein can be increased; and a waste liquid obtained by means of the system contains almost no toxin polypeptide precursor with low toxicity, and has very little toxicity to an operating environment, and same can be directly discharged after simple disinfection treatment, thereby greatly reducing production cost and promoting large-scale industrial production of polypeptide under the conditions of ensuring the safety of the environment and the safety of operators.