IP Library › Granted Patent US 12,502,420
Granted Patent B2
US 12,502,420 · App. 18/418,028 · Granted Dec 23, 2025

Patent

Inventors: Robert R. Kehrer (Garden Grove, CA); Jared Wiig (Fullerton, CA); Hui Xiang (Irvine, CA); Phillip P. Nguyen (Irvine, CA); Hemant A. Patel (Rancho Santa Margarita, CA); Connie J. Ng (Irvine, CA); Cortnie M. Guerrero (Costa Mesa, CA)
Assignee: AbbVie Inc.
A61K38/4893C12N9/52C12Y304/24069
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Quick Facts
Patent No.
US 12,502,420
App. No.
18/418,028
Granted
Dec 23, 2025
Kind
B2
Abstract

Provided herein are compositions comprising a Clostridium botulinum neurotoxin serotype A (BoNT/A) complex comprising a 150 kDa BoNT/A. Said 150 kDa BoNT/A is in the form of a plurality of sequence variant species, wherein the plurality of sequence variant species comprises a 150 kDa BoNT/A sequence variant species with a C-terminal truncated light chain.

Claims (29)

1 . A composition comprising a plurality of 900 kDa Clostridium botulinum neurotoxin serotype A (BoNT/A) complex species, wherein the composition comprises:

(a) a 900 kDa BoNT/A complex species comprising a 150 kDa BoNT/A sequence variant species with a C-terminal truncated light chain, wherein the C-terminal truncated light chain has an amino acid sequence set forth in SEQ ID NO: 4, and

(b) a 900 kDa BoNT/A complex species comprising a 150 kDa BoNT/A sequence variant species with a full-length light chain, wherein the full-length light chain has an amino acid sequence set forth in SEQ ID NO: 2 ,

wherein the abundance ratio of the 150 kDa BoNT/A sequence variant species with the C-terminal truncated light chain to the 150 kDa BoNT/A sequence variant species with the full-length light chain is less than 3.9.

2 . A composition comprising a plurality of 900 kDa BoNT/A complex species, wherein the composition comprises a 900 kDa BoNT/A complex species comprising a 150 kDa BoNT/A sequence variant species with a C-terminal truncated light chain, wherein the C-terminal truncated light chain has an amino acid sequence set forth in SEQ ID NO: 4, and wherein the abundance percentage of the 150 kDa BoNT/A sequence variant species with the C-terminal truncated light chain compared to all 150 kDa BoNT/A sequence variant species is less than 79.5%.

3 . The composition of claim 1 , wherein the abundance ratio is measured by anion exchange chromatography (AEX).

4 . The composition of claim 2 , wherein the abundance percentage is measured by AEX.

5 . The composition of claim 1 , wherein the 900 kDa BoNT/A complex is produced by Clostridium botulinum bacteria cultured and expanded from an animal product free working cell bank.

6 . The composition of claim 1 , wherein the 900 kDa BoNT/A complex is onabotulinumtoxin A.

7 . The composition of claim 1 , which further comprises about 0.5 mg of human serum albumin per 100 units of the 900 kDa BoNT/A complex and about 0.9 mg of sodium chloride per 100 units of the 900 kDa BoNT/A complex.

8 . The composition of claim 7 , wherein the human serum albumin is recombinant human serum albumin.

9 . The composition of claim 1 , which is animal product free.

10 . The composition of claim 1 , which does not contain a protease inhibitor.

11 . The composition of claim 1 , which has a potency of from about 1.5×10 7 units/mg to about 6.0×10 7 units/mg.

12 . The composition of claim 1 , which is a powdered pharmaceutical composition.

13 . The composition of claim 1 , wherein the 900 kDa BoNT/A complex is produced by a process that comprises one or more steps of column chromatography.

14 . The composition of claim 13 , wherein the one or more steps of column chromatography comprise hydrophobic interaction chromatography.

15 . The composition of claim 14 , wherein the one or more steps of column chromatography further comprise anion exchange chromatography or cation exchange chromatography.

16 . The composition of claim 2 , wherein the 900 kDa BoNT/A complex is produced by Clostridium botulinum bacteria cultured and expanded from an animal product free working cell bank.

17 . The composition of claim 2 , wherein the 900 kDa BoNT/A complex is onabotulinumtoxin A.

18 . The composition of claim 2 , which further comprises about 0.5 mg of human serum albumin per 100 units of the 900 kDa BoNT/A complex and about 0.9 mg of sodium chloride per 100 units of the 900 kDa BoNT/A complex.

19 . The composition of claim 18 , wherein the human serum albumin is recombinant human serum albumin.

20 . The composition of claim 2 , which is animal product free.

21 . The composition of claim 2 , which does not contain a protease inhibitor.

22 . The composition of claim 2 , which has a potency of from about 1.5×10 7 units/mg to about 6.0×10 7 units/mg.

23 . The composition of claim 2 , which is a powdered pharmaceutical composition.

24 . The composition of claim 2 , wherein the 900 kDa BoNT/A complex is produced by a process that comprises one or more steps of column chromatography.

25 . The composition of claim 24 , wherein the one or more steps of column chromatography comprise hydrophobic interaction chromatography.

26 . The composition of claim 25 , wherein the one or more steps of column chromatography further comprise anion exchange chromatography or cation exchange chromatography.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 16, 2024
From: KEHRER, ROBERT R.; WIIG, JARED; XIANG, HUI; NGUYEN, PHILLIP P.; PATEL, HEMANT A.; NG, CONNIE J.; GUERRERO, CORTNIE M.
To: ABBVIE INC.
Reel/Frame 068317/0339 →
Continuity (2)
Provisional Application 63480937 · Jan 20, 2023
Related Publication 20240277820A1 · Aug 22, 2024
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