IP Library › Granted Patent US 12,259,383
Granted Patent B2
US 12,259,383 · App. 17/589,067 · Granted Mar 25, 2025

Cho host cell protein assay

Inventor: Olaf Stamm (Erkrath, DE)
Assignee: Charles River Laboratories International, Inc.
G01N33/541C07K16/00C07K16/02C07K16/18G01N33/6803C07K2317/10C07K2317/11C07K2317/20C07K2317/23
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Quick Facts
Patent No.
US 12,259,383
App. No.
17/589,067
Granted
Mar 25, 2025
Kind
B2
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.

Claims (22)

1. 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,

wherein the one or more HCP-specific antibodies are produced in an aves host and are an IgY isotype,

wherein 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.

2. The kit of claim 1 , wherein the HCPs are derived from a CHO cell.

3. The kit of claim 1 , wherein the aves host is a chicken.

4. The kit of claim 1 , wherein the kit does not comprise one or more HCP-specific antibodies produced in a non-aves host.

5. The kit of claim 1 , wherein the kit does not comprise one or more HCP-specific antibodies of a non-IgY isotype.

6. The kit of claim 1 , wherein one or more HCP-specific antibodies is a polyclonal antibody.

7. 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,

wherein the second HCP-specific antibody comprises a detectable label, and

wherein the detectable label is biotin, an enzyme label, or a fluorescent label.

8. The kit of claim 7 , wherein the HCPs are derived from a CHO cell.

9. The kit of claim 7 , wherein the aves host is a chicken.

10. The kit of claim 7 , wherein the kit does not comprise one or more HCP-specific antibodies produced in a non-aves host.

11. The kit of claim 7 , wherein the kit does not comprise one or more HCP-specific antibodies of a non-IgY isotype.

12. The kit of claim 7 , wherein first and second HCP-specific antibodies are polyclonal antibodies.

Assignments (2)
SECURITY INTEREST Recorded Dec 13, 2024
From: CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 069582/0600 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2024
From: STAMM, OLAF
To: CHARLES RIVER LABORATORIES INTERNATIONAL, INC.
Reel/Frame 068936/0211 →
Continuity (3)
Division 16133828 · Sep 18, 2018
Provisional Application 62561033 · Sep 20, 2017
Related Publication 20220155285A1 · May 19, 2022
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