US2021222142A1PendingUtilityA1

Animal product free system and process for purifying a botulinum toxin

77
Assignee: ALLERGAN INCPriority: Mar 3, 2005Filed: Apr 6, 2021Published: Jul 22, 2021
Est. expiryMar 3, 2025(expired)· nominal 20-yr term from priority
Inventors:Hui Xiang
C07K 14/33C07K 1/20C07K 1/36C07K 1/18A61P 25/06A61P 21/00C12N 9/52A61P 21/02C12P 21/02C12N 1/20C12N 9/6489C12Y 304/24069A61P 1/00A61P 17/00A61P 27/02
77
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Chromatographic processes and systems for purifying a botulinum toxin from an APF fermentation medium.

Claims

exact text as granted — not AI-modified
1 - 6 . (canceled) 
     
     
         7 . A composition comprising:
 (i) a biologically active, approximately 900 kDa  Clostridium botulinum  toxin serotype A (BoNT/A) complex;   (ii) a buffer;   (iii) a salt; and   (iv) a hydrophobic interaction chromatography (HIC) media,   
       wherein:
 the composition has a pH in a range of about 5.0 to about 6.8; 
 the concentration of the salt is sufficient to bind the biologically active, approximately 900 kDa BoNT/A complex to the HIC media; and 
 the biologically active, approximately 900 kDa BoNT/A complex is bound to the HIC media. 
 
     
     
         8 . The composition of  claim 7 , wherein the composition has a pH in a range of about 5.5 to about 6.8. 
     
     
         9 . The composition of  claim 7 , wherein the biologically active, approximately 900 kDa BoNT/A complex is obtained from an animal protein-free (APF) fermentation process. 
     
     
         10 . The composition of  claim 7 , wherein the salt comprises sodium chloride. 
     
     
         11 . The composition of  claim 7 , wherein the salt comprises ammonium sulfate. 
     
     
         12 . The composition of  claim 7 , wherein the HIC media comprises phenyl sepharose media. 
     
     
         13 . The composition of  claim 7 , wherein the HIC media comprises butyl sepharose media. 
     
     
         14 . The composition of  claim 7 , wherein the HIC media comprises octyl sepharose media. 
     
     
         15 . A composition comprising:
 (i) a biologically active, approximately 900 kDa  Clostridium botulinum  toxin serotype A (BoNT/A) complex;   (ii) a buffer;   (iii) a salt; and   (iv) a hydrophobic interaction chromatography (HIC) media,   
       wherein:
 the composition has a pH in a range of about 5.0 to about 6.8; 
 the concentration of the salt is sufficient to bind the biologically active, approximately 900 kDa BoNT/A complex to the HIC media; 
 the biologically active, approximately 900 kDa BoNT/A complex is bound to the HIC media; and 
 the composition is essentially animal protein free (APF). 
 
     
     
         16 . The composition of  claim 15 , wherein the composition has a pH in a range of about 5.5 to about 6.8. 
     
     
         17 . The composition of  claim 15 , wherein the salt comprises sodium chloride. 
     
     
         18 . The composition of  claim 15 , wherein the salt comprises ammonium sulfate. 
     
     
         19 . The composition of  claim 15 , wherein the HIC media comprises phenyl sepharose media. 
     
     
         20 . The composition of  claim 15 , wherein the HIC media comprises butyl sepharose media. 
     
     
         21 . The composition of  claim 15 , wherein the HIC media comprises octyl sepharose media. 
     
     
         22 . A composition comprising:
 (i) a biologically active, approximately 900 kDa  Clostridium botulinum  toxin serotype A (BoNT/A) complex;   (ii) a buffer;   (iii) a salt; and   (iv) a hydrophobic interaction chromatography (HIC) media,   
       wherein:
 the composition has a pH in a range of about 5.0 to about 6.8; 
 the concentration of the salt is sufficient to bind the biologically active, approximately 900 kDa BoNT/A complex to the HIC media; 
 the biologically active, approximately 900 kDa BoNT/A complex is bound to the HIC media; and 
 the HIC media comprises phenyl sepharose media. 
 
     
     
         23 . The composition of  claim 22 , wherein the composition has a pH in a range of about 5.5 to about 6.8. 
     
     
         24 . The composition of  claim 22 , wherein the biologically active, approximately 900 kDa BoNT/A complex is obtained from an animal protein-free (APF) fermentation process. 
     
     
         25 . The composition of  claim 22 , wherein the composition is essentially animal protein free (APF). 
     
     
         26 . The composition of  claim 22 , wherein the salt comprises sodium chloride. 
     
     
         27 . The composition of  claim 22 , wherein the salt comprises ammonium sulfate. 
     
     
         28 . A composition comprising:
 (i) a biologically active, approximately 900 kDa  Clostridium botulinum  toxin serotype A (BoNT/A) complex;   (ii) a buffer;   (iii) a salt; and   (iv) a hydrophobic interaction chromatography (HIC) media,   
       wherein:
 the composition has a pH in a range of about 5.0 to about 6.8; 
 the concentration of the salt is sufficient to bind the biologically active, approximately 900 kDa BoNT/A complex to the HIC media; 
 the biologically active, approximately 900 kDa BoNT/A complex is bound to the HIC media; and 
 the HIC media comprises butyl sepharose media. 
 
     
     
         29 . The composition of  claim 28 , wherein the composition has a pH in a range of about 5.5 to about 6.8. 
     
     
         30 . The composition of  claim 28 , wherein the biologically active, approximately 900 kDa BoNT/A complex is obtained from an animal protein-free (APF) fermentation process. 
     
     
         31 . The composition of  claim 28 , wherein the composition is essentially animal protein free (APF). 
     
     
         32 . The composition of  claim 28 , wherein the salt comprises sodium chloride. 
     
     
         33 . The composition of  claim 28 , wherein the salt comprises ammonium sulfate.

Join the waitlist — get patent alerts

Track US2021222142A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.