Janet Yang

US Patent:

6685940, Feb 3, 2004

Filed:

Mar 14, 2001

Appl. No.:

09/809511

Inventors:

James Andya - Millbrae CA
Jeffrey L. Cleland - San Carlos CA
Chung C. Hsu - Los Altos Hills CA
Xanthe M. Lam - San Francisco CA
David E. Overcashier - El Granada CA
Steven J. Shire - Belmont CA
Janet Yu-Feng Yang - San Mateo CA
Sylvia Sau-Yan Wu - San Francisco CA

Assignee:

Genentech, Inc. - South San Francisco CA

International Classification:

A61K 39395

US Classification:

4241331, 422 40, 514 2, 514 23, 514 53

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

6821515, Nov 23, 2004

Filed:

Aug 25, 2000

Appl. No.:

09/648896

Inventors:

Jeffrey L. Cleland - San Carlos CA
Chung C. Hsu - Los Altos Hills CA
Xanthe M. Lam - San Francisco CA
David E. Overcashier - El Granada CA
Janet Yu-Feng Yang - San Mateo CA

Assignee:

Genentech, Inc. - South San Fancisco CA

International Classification:

A61K 39395

US Classification:

4241301, 4241381, 5303871

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

7060268, Jun 13, 2006

Filed:

May 2, 2003

Appl. No.:

10/428728

Inventors:

James Andya - Millbrae CA, US
Jeffrey L. Cleland - San Carlos CA, US
Chung C. Hsu - Los Altos Hills CA, US
Xanthe M. Lam - San Francisco CA, US
David E. Overcashier - El Granada CA, US
Steven J. Shire - Belmont CA, US
Janet Yu-Feng Yang - San Mateo CA, US
Sylvia Sau-Yan Wu - San Francisco CA, US

Assignee:

Genentech, Inc. - South San Francisco CA

International Classification:

A61K 39/395
C12P 21/08
C07K 16/18

US Classification:

4241301, 4241581, 4241761, 53038825, 5303893

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

7682609, Mar 23, 2010

Filed:

May 26, 2006

Appl. No.:

11/441994

Inventors:

James Andya - Milbrae CA, US
Jeffrey L. Cleland - San Carlos CA, US
Chung C. Hsu - Los Altos Hills CA, US
Xanthe M. Lam - South San Francisco CA, US
David E. Overcashier - Montara CA, US
Steven J. Shire - Emerald Hills CA, US
Janet Yu-Feng Yang - San Mateo CA, US
Sylvia Sau-Yan Wu - San Francisco CA, US

Assignee:

Genentech, Inc. - South San Franisco CA

International Classification:

A61K 39/395

US Classification:

4241301

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

20100158899, Jun 24, 2010

Filed:

Feb 2, 2010

Appl. No.:

12/698347

Inventors:

James Andya - Millbrae CA, US
Jeffrey L. Cleland - San Carlos CA, US
Chung C. Hsu - Los Altos Hills CA, US
Xanthe M. Lam - South San Francisco CA, US
David E. Overcashier - Montara CA, US
Steven J. Shire - Emerald Hills CA, US
Janet Yu-Feng Yang - San Mateo CA, US
Sylvia Sau-Yan Wu - San Francisco CA, US

International Classification:

A61K 39/395
A61K 38/16
A61P 35/00
A61P 37/02

US Classification:

4241311, 4241301, 4241331, 4241741, 514 12

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

20110236383, Sep 29, 2011

Filed:

Jun 8, 2011

Appl. No.:

13/156113

Inventors:

James Andya - Millbrae CA, US
Jeffrey L. Cleland - San Carlos CA, US
Chung C. Hsu - Los Alost Hill CA, US
Xanthe M. Lam - South San Francisco CA, US
David E. Overcashier - Montara CA, US
Steven J. Shire - Emerald Hills CA, US
Janet Yu-Feng Yang - San Mateo CA, US
Sylvia Sau-Yan Wu - San Francisco CA, US

International Classification:

A61K 39/395
A61K 38/16
A61P 43/00
B65D 69/00

US Classification:

4241331, 514 212, 4241301, 4241581, 206223

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

20130224185, Aug 29, 2013

Filed:

Sep 14, 2012

Appl. No.:

13/619576

Inventors:

James Andya - Millbrae CA, US
Jeffrey L. Cleland - San Carlos CA, US
Chung C. Hsu - Los Altos Hills CA, US
Xanthe M. Lam - South San Francisco CA, US
David E. Overcashier - Montara CA, US
Steven J. Shire - Emerald Hills CA, US
Janet Yu-Feng Yang - San Mateo CA, US
Sylvia Sau-Yan Wu - San Francisco CA, US

International Classification:

A61K 39/395
A61K 38/16

US Classification:

4241331, 514 11, 4241301

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

US Patent:

62679589, Jul 31, 2001

Filed:

Mar 14, 1996

Appl. No.:

8/615369

Inventors:

James Andya - Millbrae CA
Jeffrey L. Cleland - San Carlos CA
Chung C. Hsu - Los Altos Hills CA
Xanthe M. Lam - San Francisco CA
David E. Overcashier - El Granada CA
Steven J. Shire - Belmont CA
Janet Yu-Feng Yang - San Mateo CA
Sylvia Sau-Yan Wu - San Francisco CA

Assignee:

Genentech, Inc. - South San Francisco CA

International Classification:

A61K 39395
C07K 1600

US Classification:

4241301

Abstract:

A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.