Lakshmi K Khandke

US Patent:

7935787, May 3, 2011

Filed:

Apr 19, 2007

Appl. No.:

11/737674

Inventors:

Lakshmi Khandke - Nanuet NY, US
Ronald Malone - Madison NJ, US
Xudong Yang - Tappan NY, US
Hanyoung Han - Fort Lee NJ, US
Jee Loon Look - Gaithersburg MD, US
Zhaowei Jin - Cary NC, US
Ying Chen - Apex NC, US

Assignee:

Wyeth LLC - Madison NJ

International Classification:

A61K 31/715
C07K 14/00

US Classification:

530350, 514 54

Abstract:

The present invention addresses an ongoing need in the art to improve the stability of immunogenic compositions such as polysaccharide-protein conjugates and protein immunogens. The invention broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit particulate formation (e. g. , aggregation, precipitation) of immunogenic compositions which are processed, developed, formulated, manufactured and/or stored in container means such as fermentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like.

US Patent:

8540955, Sep 24, 2013

Filed:

Jul 9, 2008

Appl. No.:

12/169665

Inventors:

Lakshmi Khandke - Nanuet NY, US
Joseph Perez - Nanuet NY, US

Assignee:

Wyeth LLC - Madison NJ

International Classification:

C01B 25/12

US Classification:

423304, 423299

Abstract:

The present invention provides improved methods for producing the aluminum adjuvant AlPO. In one aspect, the present invention provides a method for producing aluminum phosphate which comprises the steps of mixing a solution of aluminum chloride and a solution of sodium phosphate tribasic to produce an aluminum phosphate precipitate, wherein the improvement comprises settling the aluminum phosphate precipitate at a temperature in the range of about 50 C. to about 70 C. In another aspect, the present invention is directed to methods for producing aluminum phosphate within a closed system.

US Patent:

20080187554, Aug 7, 2008

Filed:

Nov 3, 2006

Appl. No.:

11/592404

Inventors:

Lakshmi Khandke - Nanuet NY, US
Ranjit Sarpal - Monroe Twp. NJ, US
Xudong Cindy Yang - Tappan NY, US

Assignee:

Wyeth - Madison NJ

International Classification:

A61K 39/21
C07K 14/155
A61P 31/18

US Classification:

4241881, 530324

Abstract:

A process for producing a stable formulation of hydrophobic HIV Th/CTL peptides first requires the preparation of a formulation buffer containing 12.5 mM succinic acid and 3% mannitol, and adjusting the pH of the formulation buffer to 1.7 to 2.1. The hydrophobic peptides are then dissolved in the formulation buffer, filtered and lyophilized. Prior to use, the lyophilized peptides are reconstituted with 12.5 mM sodium succinate, and then mixed with at least one adjuvant to produce an immunogenic composition that is stable at 2-8 C. for at least three hours.

US Patent:

20110172393, Jul 14, 2011

Filed:

Mar 24, 2011

Appl. No.:

13/070664

Inventors:

Lakshmi Khandke - Nanuet NY, US
Ronald Malone - Madison NJ, US
Xudong Yang - Tappan NY, US
Hanyoung Han - Fort Lee NJ, US
Jee Loon Look - Gaithersburg MD, US
Zhaowei Jin - Cary NC, US
Ying Chen - Apex NC, US

Assignee:

WYETH LLC - Madison NJ

International Classification:

C07K 14/22

US Classification:

530350

Abstract:

The present invention addresses an ongoing need in the art to improve the stability of immunogenic compositions such as polysaccharide-protein conjugates and protein immunogens. The invention broadly relates to novel formulations which stabilize and inhibit precipitation of immunogenic compositions. More particularly, the invention described hereinafter, addresses a need in the art for formulations which stabilize and inhibit particulate formation (e.g., aggregation, precipitation) of immunogenic compositions which are processed, developed, formulated, manufactured and/or stored in container means such as fermentors, bioreactors, vials, flasks, bags, syringes, rubber stoppers, tubing and the like.

US Patent:

20130072881, Mar 21, 2013

Filed:

May 25, 2011

Appl. No.:

13/701707

Inventors:

Lakshmi Khandke - Nanuet NY, US
Abbas Rashidbaigi - Basking Ridge NJ, US

Assignee:

WYETH LLC - Madison NJ

International Classification:

A61K 39/385
A61M 5/24
A61M 5/31

US Classification:

604191, 42419711

Abstract:

An immunogenic composition comprising a plurality of capsular polysaccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to a carrier protein, and further comprising at least one preservative, preferably 2-phenoxyethanol (2-PE). The preservative-containing immunogenic compositions of the invention confer resistance to one or more micro-organisms and are useful for producing multi-dose vaccine formulations having advantageous properties with respect to long term stability of the different antigenic determinants in the immunogenic composition of choice. Related compositions and methods for measuring the efficacy of one or more preservatives in a vaccine formulation are also provided.

US Patent:

20130171194, Jul 4, 2013

Filed:

Aug 22, 2011

Appl. No.:

13/814285

Inventors:

Lakshmi Khandke - Nanuet NY, US
Rasappa Arumugham - Lansdale PA, US
Bounthon Loun - Dardenne Prairie MO, US

Assignee:

WYETH LLC - Madison NJ

International Classification:

C07K 14/22
A61K 31/4172
A61K 31/194
A61K 38/16

US Classification:

4242501, 530350, 436510

Abstract:

The present invention relates to stable formulations of rLP2086 Subfamily B Antigens in immunogenic compositions. The present invention also relates to methods of preserving the conformation of rLP2086 Antigens and methods for determining the potency of rLP2086 antigens.

US Patent:

20130259896, Oct 3, 2013

Filed:

Dec 21, 2011

Appl. No.:

13/993887

Inventors:

Lakshmi Khandke - Nanuet NY, US
Akihisa Nonoyama - Apex NC, US
Tamara Shafer Hodge - Chesterfield MO, US
Sandeep Nema - Chesterfield MO, US

International Classification:

A61K 39/085

US Classification:

42419711, 4242431

Abstract:

The present invention is directed towards a lyophilized or reconstituted multi-antigen or multicomponent immunogenic composition comprising at least one antigen isolated from a staphylococcal bacterium, and methods of making the same.

US Patent:

7608278, Oct 27, 2009

Filed:

Dec 28, 2004

Appl. No.:

10/585050

Inventors:

Susan Kay Hoiseth - Montebello NY, US
Yury Vladimirovich Matsuka - New Windsor NY, US
Michael Hagen - Pittsford NY, US
Lakshmi Khandke - Nanuet NY, US

Assignee:

Wyeth - Madison NJ

International Classification:

A61K 45/00
A61K 47/00
A61K 49/00

US Classification:

4242781, 424 91, 424 92

Abstract:

The present invention provides a method for producing a less-painful immunogenic composition of a hydrophobic protein in a pharmaceutically acceptable carrier suitable for administering to a mammal, comprising the steps of (a) solubilizing said hydrophobic protein with a zwitterionic detergent to make a first composition; (b) altering said first composition, such that the altered composition produces a reduction in pain as measured in the rat footpad model as compared to said first composition.