Methods and devices for the enrichment of immunoglobulin from blood
Inventors
Assignees
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Publication Number
US-12668609-B2
Publication Date
2026-06-30
Expiration Date
Abstract
A method for extracting at least 55% of immunoglobulin such as IgG from a biological fluid. The biological fluid containing immunoglobulin is contacted with a solid support covalently bonded to a ligand that specifically binds to immunoglobulin under conditions sufficient for non-covalent binding of immunoglobulin to the ligand. The solid support is contacted with an elution solution under conditions whereby the non-covalently bound immunoglobulin is released from the ligand and into the elution solution, wherein at least 55% of the IgG present in the biological fluid is extracted into the elution solution. The method, in some embodiments, provides a method for enriching immunoglobulin from a biological fluid comprising obtaining an initial biological fluid suspected of containing immunoglobulin and removing non-immunoglobulin components naturally occurring in the initial biological fluid to obtain a non-immunoglobulin component-reduced biological fluid.
Core Innovation
The invention provides closed-system methods and in-line apheresis systems for processing plasma separated from donor whole blood. A centrifuge bowl separates plasma from other blood components and directs the plasma to an in-line solid support covalently bonded to a ligand. One method captures immunoglobulin directly for elution and collection, whereas another method binds a non-immunoglobulin component to collect immunoglobulin-enriched plasma.
The separation container, centrifuge bowl, and collection container remain coupled as a closed set to prevent loss of sterility. Other blood components return to the donor while additional whole blood is withdrawn, enabling chair-side processing during continuous collection. Reported configurations include radial columns that reduce backpressure compared with axial columns, with extraction targets of at least 55% recovery.
Claims Coverage
The two independent claims cover two primary inventive features directed to donor blood processing in a closed, in-line set.
Collection of immunoglobulin from donor whole blood
A centrifuge bowl separates plasma from donor whole blood and directs it to an in-line separation container having a solid support covalently bonded to a ligand that binds immunoglobulin. An elution solution releases the immunoglobulin into a collection container within the closed set, and other blood components are returned to the donor during continued collection.
Collection of immunoglobulin-enriched plasma
A closed, in-line system separates plasma from donor whole blood and contacts the plasma with a ligand-bearing solid support that binds a non-immunoglobulin component. The system collects immunoglobulin-enriched plasma depleted of that component while returning one or more other blood components to the donor during continued collection.
The independent claims cover closed-system blood-processing methods that separate plasma from donor whole blood to collect either purified immunoglobulin or immunoglobulin-enriched plasma, while returning other blood components to the donor during continued collection.
Stated Advantages
The closed system is configured to prevent the loss of sterility within the set.
The method can be performed chair-side by the donor.
Radial columns are reported to reduce backpressure and provide substantially lower pressure drops compared with axial columns.
The disclosure reports an extraction target of at least 55% and an embodiment with 92% recovery of captured IgG without observed IgG breakthrough.
Documented Applications
Collecting immunoglobulin, particularly IgG, from plasma separated from donor whole blood, with other blood components returned to the donor.
Producing immunoglobulin-enriched plasma by removing non-immunoglobulin components, including albumin, from donor whole blood.
Use in apheresis systems involving plasma, platelet-rich plasma, and whole blood, including plasmapheresis and plateletpheresis.
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