Cho host cell protein assay
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Publication Number
US-12259383-B2
Publication Date
2025-03-25
Expiration Date
Abstract
The present invention provides compositions, kits, and methods for the detection of host cell proteins (HCPs) in biological samples. In some embodiments, the present invention utilizes immunization of aves hosts with proteins derived from non-aves host cells to produce aves antibodies specific for non-aves HCPs.
Core Innovation
The invention provides a kit comprising one or more host cell protein (HCP)-specific antibodies for use in the detection of one or more HCPs in a biological sample, where the HCPs are derived from a non-aves host and the HCP-specific antibodies are produced in an aves host and are an IgY isotype. The HCP-specific antibodies are capable of detecting at least 85% of the HCP proteins present in the sample.
In one embodiment, the kit includes an HCP-specific antibody comprising a detectable label, where the detectable label is biotin, an enzyme label or a fluorescent label. In another embodiment, the kit includes a first and a second HCP-specific antibody, both produced in an aves host as IgY isotype, with the first antibody capable of detecting at least 85% of the HCP proteins present and the second antibody comprising the detectable label.
The disclosed approach emphasizes using aves-derived IgY antibodies raised against non-aves HCP antigens for broad HCP detection in biological samples. The document reports increased sensitivity and broad HCP coverage, and it describes characterization and validation of HCP-IgY binding performance using binding-based detection formats including ELISA and Western blot and detectable labels.
Claims Coverage
The partial claims provided include two independent kit claims. Across these independent claims, the coverage centers on HCP-specific IgY antibodies produced in an aves host for detecting non-aves-derived HCPs in a biological sample, including at least 85% detection of HCP proteins and inclusion of a detectable label selected from biotin, an enzyme label, or a fluorescent label, with a two-antibody configuration in the second independent claim.
A detection kit with non-aves derived HCPs and aves-produced IgY antibodies
A kit comprising one or more host cell protein (HCP)-specific antibodies for use in the detection of one or more HCPs in a biological sample, wherein the HCPs are derived from a non-aves host, and wherein the one or more HCP-specific antibodies are produced in an aves host and are an IgY isotype.
At least 85% HCP protein coverage and labeled antibody
The one or more HCP-specific antibodies are capable of detecting at least 85% of the HCP proteins present in the sample, wherein the one or more HCP-specific antibodies comprise a detectable label, and wherein the detectable label is biotin, an enzyme label or a fluorescent label.
Two IgY antibodies for HCP detection with labeled second antibody
A kit comprising a first and a second host cell protein (HCP)-specific antibody for use in the detection of one or more HCPs in a biological sample, wherein the HCPs are derived from a non-aves host, wherein the first and the second HCP-specific antibodies are produced in an aves host and are an IgY isotype, and wherein the first HCP-specific antibody is capable of detecting at least 85% of the HCP proteins present in the sample.
Detectable label selection for second antibody
The second HCP-specific antibody comprises a detectable label, and wherein the detectable label is biotin, an enzyme label, or a fluorescent label.
Overall, the claim coverage is directed to binding-based detection kits that use aves-host IgY HCP-specific antibodies for detecting non-aves-derived HCPs in biological samples, requiring at least 85% detection of HCP proteins and inclusion of a detectable label selected from biotin, an enzyme label, or a fluorescent label; the second independent claim additionally specifies a two-antibody arrangement with a labeled second antibody.
Stated Advantages
Higher sensitivity, reported as 8–9 fold and limit of detection (LOD) down to about 2–8 ng/mL.
Broad HCP coverage, claimed to detect at least about 90–99% of contaminating HCPs.
Documented Applications
Detection of host cell proteins (HCPs) in a biological sample using HCP-IgY binding-based detection formats including ELISA and Western blot (including sandwich, direct, and competitive formats).
Use in kit-based HCP detection with antibodies comprising detectable labels selected from biotin, enzyme labels, or fluorescent labels.
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