Quality control reagents and methods for serum antibody profiling
Inventors
Kamath, Kathryn Vinaya Louise • Reifert, Jack Ryan • Daugherty, Patrick Sean
Assignees
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Publication Number
US-12297564-B2
Publication Date
2025-05-13
Expiration Date
Abstract
Disclosed herein are reagents for use in quality control assessment of antibody profiling platforms, such as biopanning and Digital Serology. Also disclosed herein are kits, method of manufacturing, and methods of using the same.
Core Innovation
The invention provides a peptide expression library composition comprising a library of nucleic acid sequences encoding a library of peptides. The composition further includes one or more control vectors comprising a nucleic acid sequence encoding a control binding target of a control binding molecule, where the control binding target is identical for each control vector, and a unique nucleic acid sequence that is specific for each control vector.
In embodiments, the composition defines a peptide library composition comprising a library of nucleic acid sequences encoding a library of random peptides and two control vectors. Each control vector encodes an epitope sequence that is identical for each control vector and that is a known binding target of a control binding molecule, where the control binding molecule comprises an antibody or fragment thereof. The control vectors further include unique nucleic acid sequences that are specific for each control vector and that encode unique peptide sequences capable of being expressed as part of a polypeptide comprising the epitope sequence.
The invention also provides an assay quality control method in which a sample known or suspected to have specimen binding molecules is contacted with the peptide expression library composition and the control binding molecule under conditions that promote binding of the control binding molecule to the control binding target. The peptide expression library composition includes two or more array surfaces configured to display one or more copies of either the peptides of the library or the control binding target encoded by the control vectors.
Claims Coverage
The partial content identifies three independent claims. Across these independent claims, the main inventive elements are the shared control binding target with unique nucleic acid sequences, display on array surfaces of either peptide library members or the control binding target, and use in an assay quality control method by contacting a sample with the peptide expression library composition and a control binding molecule to promote binding to the control binding target.
Control binding target with control vector-specific unique nucleic acid sequences
A peptide expression library composition comprising a library of nucleic acid sequences encoding a library of peptides, and one or more control vectors comprising a nucleic acid sequence encoding a control binding target of a control binding molecule, wherein the control binding target is identical for each control vector, and a unique nucleic acid sequence specific for each control vector.
Two control vectors expressing an identical epitope plus unique peptide-coding sequences on array surfaces
A peptide library composition comprising a library of nucleic acid sequences encoding a library of random peptides; two control vectors each comprising a nucleic acid sequence encoding an epitope sequence identical for each control vector and being a known binding target of a control binding molecule comprising an antibody or fragment thereof, and a unique nucleic acid sequence specific for each control vector that encodes a unique peptide sequence capable of being expressed as part of a polypeptide comprising the epitope sequence; and two or more array surfaces configured to display multiple copies of one of the random peptides or the epitope sequence encoded by the control vectors.
Assay quality control by contacting sample with peptide library and control binding molecule for binding to displayed control binding target
A method of assay quality control comprising providing a sample known or suspected to have specimen binding molecules; providing a peptide expression library composition comprising a library of nucleic acid sequences encoding a library of peptides; one or more control vectors comprising a nucleic acid sequence encoding a control binding target that is identical for each control vector and a unique nucleic acid sequence specific for each control vector; and two or more array surfaces configured to display one or more copies of either the peptides or the control binding target encoded by the control vectors; providing the control binding molecule; and contacting the sample with the peptide expression library composition and the control binding molecule under conditions that promote binding of the control binding molecule to the control binding target.
Across the identified claims, the claim coverage centers on peptide expression library compositions that pair a shared control binding target with control-vector-specific unique nucleic acid sequences, optionally tied to random peptide libraries and epitope/antibody binding targets, and on assay quality control that uses array-surface display and contacting with a control binding molecule to enable binding to the displayed control binding target.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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