IP Library Granted Patent US 12,480,947
Granted Patent B2
US 12,480,947 · App. 18/375,755 · Granted Nov 25, 2025

Method for generating high affinity antibodies

Inventors: Gang Chen (Yorktown Heights, NY); Robert Babb (River Edge, NJ); James P. Fandl (LaGrangeville, NY)
Assignee: REGENERON PHARMACEUTICALS, INC.
G01N33/56972C07K16/00C07K16/22C07K16/32G01N33/50C07K2317/10C07K2317/92C12N2510/02
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Quick Facts
Patent No.
US 12,480,947
App. No.
18/375,755
Granted
Nov 25, 2025
Kind
B2
Abstract

The present disclosure relates to a method for identifying cells that express antigen-specific antibodies with a high binding affinity for a monomeric antigen. Using fluorescence activated cell sorting, cells expressing high affinity antigen-specific antibodies are selected from a population of immune cells isolated from a mammal that has been immunized with or otherwise exposed to the antigen. Nucleic acids encoding the high affinity antibodies can then be cloned into other lymphoid and non-lymphoid cells where the antibody can be expressed and from which the antibodies can be secreted.

Claims (27)

1 . A method for selecting primary antibody-producing cells that express antibodies exhibiting high binding affinity for an antigen of interest, the method comprising:

(a) contacting a population of primary antibody-producing cells that express antibody to the antigen of interest for a time sufficient for antigen to bind to antibody on the surface of the cells, wherein the concentration of the antigen of interest is 0.1 to 2 nM;

(b) washing the cells for a period of time to remove unbound antigen;

(c) collecting cells bound to the antigen of interest;

(d) sorting the cells collected in step (c) to obtain cells that express antibodies of high affinity, wherein the high affinity antibodies have a dissociation equilibrium constant (K D ) of 0.1 pM to 25 nM.

2 . The method of claim 1 , wherein the antigen is a monomeric protein.

3 . The method of claim 2 , wherein the antigen comprises a detectable label.

4 . The method of claim 3 , wherein the detectable label is conjugated directly to the antigen.

5 . The method of claim 4 , wherein the detectable label is conjugated to antigen via a pair of binding partners.

6 . The method of claim 5 , wherein one binding partner of the pair of binding partners is labeled with a detectable label.

7 . The method of claim 5 , wherein the pair of binding partners is biotin/streptavidin.

8 . The method of claim 5 , wherein the antigen is biotinylated and the binding partner is streptavidin comprising a detectable label.

9 . The method of claim 8 , further comprising contacting cells that bind biotinylated antigen with streptavidin after step (b) and before step (c).

10 . The method of claim 3 , wherein the detectable label is a fluorescent label.

11 . The method of claim 10 , wherein step (c) comprises using fluorescence-activated cell sorting to obtain cells that express antibody with high affinity for the antigen of interest.

12 . The method of claim 3 , further comprising collecting the cells that bind detectable label to isolate cells that express antibodies of high affinity for the antigen of interest.

13 . The method of claim 1 , wherein the concentration of antigen is about 1 nM.

14 . The method of claim 1 , wherein cells of the population of cells express antibody that is membrane-bound antibody.

15 . The method of claim 1 , wherein the period of time for washing the cells is between about 5 minutes to about 60 minutes.

16 . The method of claim 1 , wherein the washing the cells for a period of time comprises two (2) washes of about 5 minutes to about 30 minutes per wash.

17 . The method of claim 1 , further comprising isolating cells that express antibodies of high affinity from the collected cells bound to antigen.

18 . The method of claim 1 , wherein the primary antibody-producing cells are obtained from spleen, lymph node, peripheral blood and/or bone marrow.

19 . The method of claim 1 , wherein the affinity of the antibody is between about 0.1 pM to about 10 nM (K D ).

20 . The method of claim 1 , further comprising step (e), which comprises:

(i) isolating an antibody-encoding nucleic acid from the cells that express antibodies of high affinity of step (d);

transfecting a host cell with a vector comprising the antibody-encoding nucleic acid; and

(iii) growing the transfected host cell under conditions to support expression of antibody by the host cell.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2024
From: CHEN, GANG; BABB, ROBERT; FANDL, JAMES P.
To: REGENERON PHARMACEUTICALS, INC.
Reel/Frame 068872/0894 →
Continuity (4)
Continuation 16987639 · Aug 7, 2020
Continuation 15526522
Provisional Application 62079899 · Nov 14, 2014
Related Publication 20240036043A1 · Feb 1, 2024
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