Methods for increasing the capacity of purification processes
Inventors
Natarajan, Venkatesh • Lutz, Herbert • Raghunath, Bala
Assignees
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Publication Number
US-12297229-B2
Publication Date
2025-05-13
Expiration Date
Abstract
In various embodiments, the present invention provides a process for separating target proteins from non-target proteins in a sample comprising increasing the concentration of the target proteins and non-target proteins in the sample and subsequently delivering the concentrated sample to a chromatography device. In other embodiments, the invention relates to a process for increasing the capacity of a chromatography device for a target protein by delivering a concentrated sample comprising the target protein to a chromatography device.
Core Innovation
The invention describes a process for purifying target proteins from non-target proteins in a liquid sample. The process increases the concentration of both target proteins and non-target proteins in the liquid sample using a single-pass tangential flow filtration (SPTFF) process to produce a concentrated feed having a protein concentration of 5 g/L or greater.
After concentration, the concentrated feed is delivered to a protein A chromatography device, where the SPTFF process provides direct flow-through concentration of the liquid sample to the protein A chromatography device. The method then separates the target proteins from the non-target proteins in the protein A chromatography device and recovers the target proteins in a recovered sample.
The invention further states that the capacity of the protein A chromatography device is increased to about 10 kg to 15 kg per liter of chromatography media. The disclosed examples include increasing chromatography capacity by concentrating both target and non-target proteins prior to loading, and show capacity-related outcomes for different chromatography contexts and media/device costs.
Claims Coverage
The independent claim describes a purification process with four inventive aspects: SPTFF concentration to a specified protein concentration, direct flow-through delivery to a protein A chromatography device, protein A separation of target from non-target proteins with recovery of target proteins, and a specified device-capacity increase quantified as about 10 kg to 15 kg per liter of chromatography media.
SPTFF concentration of target and non-target proteins to at least 5 g/L
A process comprising increasing a concentration of target proteins and non-target proteins in a liquid sample by a single-pass tangential flow filtration (SPTFF) process to produce a concentrated feed having a protein concentration of 5 g/L or greater.
Direct flow-through delivery to a protein A chromatography device
Delivering the concentrated feed to a protein A chromatography device, wherein the SPTFF process provides direct flow-through concentration of the liquid sample to the protein A chromatography device.
Protein A separation and recovery of target proteins
Separating the target proteins from the non-target proteins in the protein A chromatography device, and recovering the target proteins from the protein A chromatography device in a recovered sample.
Capacity increase to about 10 kg to 15 kg per liter of media
Determining that the capacity of the protein A chromatography device is increased to about 10 kg to 15 kg per liter of chromatography media.
Across the independent claim, the inventive concept is to use SPTFF to concentrate both target and non-target proteins to at least 5 g/L and deliver that concentrated stream directly to a protein A chromatography device for separation and recovery, achieving an increased device capacity of about 10 kg to 15 kg per liter of chromatography media.
Stated Advantages
Increased capacity of the protein A chromatography device to about 10 kg to 15 kg per liter of chromatography media.
Lower economical capacity requirements via higher mass loading per media volume as described for the disclosed contexts.
Reduced protein A chromatography media cost per amount of target protein as described using a ~5 g/L concentrated feed after SPTFF.
Reduced virus filter costs by reducing downstream consumable cost per gram as described for the disclosed contexts.
Documented Applications
Protein A affinity chromatography purification of target proteins from non-target proteins, including separating and recovering monoclonal antibodies from non-target proteins.
Anion exchange (AEX) chromatography capacity-related context described through increased HCP breakthrough/loading when using more-concentrated MAb feed.
Protein A chromatography media cost reduction context using PROSEP/PROSEP Ultra Plus (PUP) media with SPTFF concentration to about 5 g/L.
Virus filtration cost reduction context using VIRESOLVE Pro viral filtration devices with SPTFF concentration to reduce downstream consumable cost per gram.
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