Susan J Babuka

US Patent:

7371373, May 13, 2008

Filed:

Feb 18, 2005

Appl. No.:

11/062146

Inventors:

Bret A. Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Bao-Lu Chen - San Ramon CA, US
Maninder Hora - Danville CA, US
Minna Choe - Danville CA, US
Melanie Tellers - Cranford NJ, US

Assignee:

Novartis Vaccines and Diagnostics, Inc. - Emeryville CA

International Classification:

A61K 45/00
C07K 17/00

US Classification:

424 866, 424 851, 530351

Abstract:

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3. 0 to about 5. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.

US Patent:

7399463, Jul 15, 2008

Filed:

Apr 9, 2004

Appl. No.:

10/821333

Inventors:

Bret A. Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Bao-Lu Chen - San Ramon CA, US
Maninder Hora - Danville CA, US
Minna Choe - Danville CA, US
Melanie Tellers - Cranford NJ, US

Assignee:

Novartis Vaccines and Diagnostics, Inc. - Emeryville CA

International Classification:

A61K 45/00
C07K 17/00

US Classification:

424 856, 424 851, 530351

Abstract:

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3. 0 to about 5. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.

US Patent:

7544354, Jun 9, 2009

Filed:

Oct 25, 2001

Appl. No.:

10/035420

Inventors:

Sidney N. Wolfe - Lafayette CA, US
Bret A. Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Dennis Fordham - Richmond CA, US
Irina Esikova - Fremont CA, US

Assignee:

Novartis Vaccines and Diagnostics - Emeryville CA

International Classification:

A61K 38/21
C07K 17/00

US Classification:

424 856, 424 851, 530351

Abstract:

Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

US Patent:

7892531, Feb 22, 2011

Filed:

Apr 9, 2008

Appl. No.:

12/082177

Inventors:

Bret A Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Bao-Lu Chen - San Ramon CA, US
Maninder Hora - Danville CA, US
Minna Choe - Danville CA, US
Melanie Tellers - Cranford NJ, US

Assignee:

Novartis Vaccines and Diagnostics - Emeryville CA

International Classification:

A61K 45/00
C07K 17/00

US Classification:

424 856, 424 851, 530351

Abstract:

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3. 0 to about 5. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.

US Patent:

8333958, Dec 18, 2012

Filed:

Jan 11, 2011

Appl. No.:

13/004658

Inventors:

Bret A Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Bao-Lu Chen - San Ramon CA, US
Maninder Hora - Danville CA, US
Minna Choe - Danville CA, US
Melanie Tellers - Cranford NJ, US

Assignee:

Novartis Vaccines and Diagnostics, Inc. - Emeryville CA

International Classification:

A61K 45/00
C07K 17/00

US Classification:

424 856, 424 851, 530351, 514 179

Abstract:

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-β) and methods useful in their preparation are provided. The compositions comprise the IFN-β solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3. 0 to about 5. Methods for preparing these compositions, and for increasing solubility of IFN-β in pharmaceutical compositions, are provided.

US Patent:

8388942, Mar 5, 2013

Filed:

Apr 29, 2008

Appl. No.:

12/150530

Inventors:

Sidney N Wolfe - Lafayette CA, US
Bret A Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Dennis Fordham - Richmond CA, US
Irina Esikova - Fremont CA, US

Assignee:

Novartis Vaccines and Diagnostics, Inc. - Emeryville CA

International Classification:

A61K 38/21
C07K 14/565

US Classification:

424 856, 530351

Abstract:

Improved methods for purification and recovery of interferon-beta (IFN-β) and compositions comprising substantially monomeric IFN-β are provided. In one purification method, substantially purified IFN-β or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-β, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-β.

US Patent:

20020172661, Nov 21, 2002

Filed:

Oct 25, 2001

Appl. No.:

10/035397

Inventors:

Bret Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Bao-Lu Chen - San Ramon CA, US
Maninder Hora - Danville CA, US
Minna Choe - Danville CA, US
Melanie Tellers - Cranford NJ, US

Assignee:

Chiron Corporation

International Classification:

A61K038/21

US Classification:

424/085600

Abstract:

Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-) and methods useful in their preparation are provided. The compositions comprise the IFN- solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN- in pharmaceutical compositions, are provided.

US Patent:

20040115169, Jun 17, 2004

Filed:

Dec 31, 2003

Appl. No.:

10/750076

Inventors:

Sidney Wolfe - Lafayette CA, US
Bret Shirley - Waltham MA, US
Susan Babuka - Oakland CA, US
Dennis Fordham - Richmond CA, US
Irina Esikova - Fremont CA, US

Assignee:

Chiron Corporation - Emeryville CA

International Classification:

A61K038/21
C07K014/56

US Classification:

424/085600, 530/351000

Abstract:

Improved methods for purification and recovery of interferon-beta (IFN-) and compositions comprising substantially monomeric IFN- are provided. In one purification method, substantially purified IFN- or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-.