Protein formulation

Details Protein formulation Protein formulation

2006-06-13

2006-06-13

Chan, Christina (Department: 1644)

Drug, bio-affecting and body treating compositions

Immunoglobulin, antiserum, antibody, or antibody fragment,...

C424S158100, C424S176100, C530S388250, C530S389300

Reexamination Certificate

active

07060268

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.

REFERENCES:
patent: 4093606 (1978-06-01), Coval
patent: 4499073 (1985-02-01), Tenold
patent: 4714759 (1987-12-01), Whitaker, Jr.
patent: 4753894 (1988-06-01), Frankel et al.
patent: 4816567 (1989-03-01), Cabilly et al.
patent: 4861579 (1989-08-01), Meyer et al.
patent: 4877608 (1989-10-01), Lee et al.
patent: 4891319 (1990-01-01), Roser
patent: 4935341 (1990-06-01), Bargmann et al.
patent: 4940782 (1990-07-01), Rup et al.
patent: 4943533 (1990-07-01), Mendelsohn et al.
patent: 4946788 (1990-08-01), Delespesse
patent: 4962035 (1990-10-01), Leder et al.
patent: 4968603 (1990-11-01), Slamon et al.
patent: 4975278 (1990-12-01), Senter et al.
patent: 5032405 (1991-07-01), Huang et al.
patent: 5091313 (1992-02-01), Chang
patent: 5096885 (1992-03-01), Pearlman et al.
patent: 5149653 (1992-09-01), Roser
patent: 5169774 (1992-12-01), Frankel et al.
patent: 5183884 (1993-02-01), Kraus et al.
patent: 5215743 (1993-06-01), Singh et al.
patent: 5231026 (1993-07-01), Chang
patent: 5252467 (1993-10-01), Chang
patent: 5254671 (1993-10-01), Chang
patent: 5260416 (1993-11-01), Chang
patent: 5262296 (1993-11-01), Ogawa et al.
patent: 5274075 (1993-12-01), Chang
patent: 5288477 (1994-02-01), Bacus
patent: 5292867 (1994-03-01), Chang
patent: 5342924 (1994-08-01), Chang
patent: 5359046 (1994-10-01), Capon et al.
patent: 5362643 (1994-11-01), Chang
patent: 5367060 (1994-11-01), Vandlen et al.
patent: 5399670 (1995-03-01), Bhattacharya et al.
patent: 5401638 (1995-03-01), Carney et al.
patent: 5410025 (1995-04-01), Moller et al.
patent: 5420251 (1995-05-01), Chang et al.
patent: 5422258 (1995-06-01), Chang
patent: 5428133 (1995-06-01), Chang
patent: 5464751 (1995-11-01), Greene et al.
patent: 5480968 (1996-01-01), Kraus et al.
patent: 5514554 (1996-05-01), Bacus
patent: 5571894 (1996-11-01), Wels et al.
patent: 5578482 (1996-11-01), Lippman et al.
patent: 5580856 (1996-12-01), Prestrelski et al.
patent: 5587458 (1996-12-01), King et al.
patent: 5589167 (1996-12-01), Cleland et al.
patent: 5604107 (1997-02-01), Carney et al.
patent: 5608038 (1997-03-01), Eibl et al.
patent: 5641869 (1997-06-01), Vandlen et al.
patent: 5654403 (1997-08-01), Smith et al.
patent: 5663144 (1997-09-01), Greene et al.
patent: 5677171 (1997-10-01), Hudziak et al.
patent: 5705157 (1998-01-01), Greene
patent: 5720937 (1998-02-01), Hudziak et al.
patent: 5720954 (1998-02-01), Hudziak et al.
patent: 5725856 (1998-03-01), Hudziak et al.
patent: 5726023 (1998-03-01), Cheever et al.
patent: 5728687 (1998-03-01), Bissery
patent: 5747261 (1998-05-01), King et al.
patent: 5763409 (1998-06-01), Bayol et al.
patent: 5770195 (1998-06-01), Hudziak et al.
patent: 5772997 (1998-06-01), Hudziak et al.
patent: 5776427 (1998-07-01), Thorpe et al.
patent: 5783186 (1998-07-01), Arakawa et al.
patent: 5792838 (1998-08-01), Smith et al.
patent: 5801005 (1998-09-01), Cheever et al.
patent: 5821337 (1998-10-01), Carter et al.
patent: 5824311 (1998-10-01), Greene et al.
patent: 5834229 (1998-11-01), Vandlen et al.
patent: 5837243 (1998-11-01), Deo et al.
patent: 5837523 (1998-11-01), Greene et al.
patent: 5840525 (1998-11-01), Vandlen et al.
patent: 5846538 (1998-12-01), Cheever et al.
patent: 5849700 (1998-12-01), Sorensen et al.
patent: 5856110 (1999-01-01), Vandlen et al.
patent: 5859206 (1999-01-01), Vandlen et al.
patent: 5869445 (1999-02-01), Cheever et al.
patent: 5876712 (1999-03-01), Cheever et al.
patent: 5877305 (1999-03-01), Huston et al.
patent: 5908835 (1999-06-01), Bissery
patent: 5910486 (1999-06-01), Curiel et al.
patent: 5922845 (1999-07-01), Deo et al.
patent: 5939531 (1999-08-01), Wels et al.
patent: 5942210 (1999-08-01), Ultee et al.
patent: 5965709 (1999-10-01), Presta et al.
patent: 5977322 (1999-11-01), Marks et al.
patent: 5985553 (1999-11-01), King et al.
patent: 6015567 (2000-01-01), Hudziak et al.
patent: 6028059 (2000-02-01), Curiel et al.
patent: 6054297 (2000-04-01), Carter et al.
patent: 6054561 (2000-04-01), Ring
patent: 6080429 (2000-06-01), Cleland et al.
patent: 6123939 (2000-09-01), Shawver et al.
patent: 6165464 (2000-12-01), Hudziak et al.
patent: 6267958 (2001-07-01), Andya et al.
patent: 6685940 (2004-02-01), Andya et al.
patent: 6821515 (2004-11-01), Cleland et al.
patent: 2004/0197326 (2004-10-01), Fick et al.
patent: B-30771/89 (1989-09-01), None
patent: 2138853 (1995-06-01), None
patent: 171496 (1986-02-01), None
patent: 173494 (1986-03-01), None
patent: 184187 (1986-06-01), None
patent: 255249 (1988-02-01), None
patent: 263655 (1988-04-01), None
patent: 303746 (1989-02-01), None
patent: 317295 (1989-05-01), None
patent: 391444 (1990-10-01), None
patent: 0 531 539 (1993-03-01), None
patent: 589840 (1994-03-01), None
patent: 597101 (1994-05-01), None
patent: 0599274 (1994-06-01), None
patent: 616812 (1994-09-01), None
patent: 617127 (1994-09-01), None
patent: 648499 (1995-04-01), None
patent: 661060 (1995-07-01), None
patent: 841067 (1998-05-01), None
patent: 711565 (1998-08-01), None
patent: WO 84/00890 (1984-03-01), None
patent: WO 86/01533 (1986-03-01), None
patent: WO 89/04834 (1989-06-01), None
patent: WO 89/06138 (1989-07-01), None
patent: WO 89/06692 (1989-07-01), None
patent: WO 89/09402 (1989-10-01), None
patent: WO 89/11297 (1989-11-01), None
patent: WO 90/11091 (1990-10-01), None
patent: WO 91/11456 (1991-08-01), None
patent: WO 92/10573 (1992-06-01), None
patent: WO 92/22653 (1992-12-01), None
patent: WO 93/04173 (1993-03-01), None
patent: WO 93/05799 (1993-04-01), None
patent: WO 93/12220 (1993-06-01), None
patent: WO 93/19197 (1993-09-01), None
patent: WO 93/21232 (1993-10-01), None
patent: WO 93/21319 (1993-10-01), None
patent: WO 94/00136 (1994-01-01), None
patent: WO 94/10202 (1994-05-01), None
patent: WO 94/22478 (1994-10-01), None
patent: WO 94/28127 (1994-12-01), None
patent: WO 95/11009 (1995-04-01), None
patent: WO 95/15977 (1995-06-01), None
patent: WO 95/16051 (1995-06-01), None
patent: WO 95/17507 (1995-06-01), None
patent: WO 95/28485 (1995-10-01), None
patent: WO 96/18409 (1996-06-01), None
patent: WO 96/30046 (1996-10-01), None
patent: WO 97/04807 (1997-02-01), None
patent: WO 97/10004 (1997-03-01), None
patent: WO 97/20858 (1997-06-01), None
patent: WO 97/27848 (1997-08-01), None
patent: WO 97/33616 (1997-09-01), None
patent: WO 97/38731 (1997-10-01), None
patent: WO 97/45140 (1997-12-01), None
patent: WO 98/22136 (1998-05-01), None
patent: WO 98/45479 (1998-10-01), None
patent: WO 99/01556 (1999-01-01), None
US 5,036,049, 7/1991, Audhya et al. (withdrawn)
Roy et al., “The Effects of Formulation and Moisture on the Stability of a Freeze-Dried Monclonal Antibody -Vinca Conjugate: A Test of the WLF Glass Transition Theory”DNA and Cell Biology74:323-340 (1991).
Arakawa et al., “Protein-Solvent Interactions in Pharmaceutical Formulations”Pharmaceutical Research8(3):285-291 (1991).
Ram et al., “Stability of Protein Formulations: Investigation of Surfactant Effects by a Novel EPR Spectroscopic Technique”Pharm. Res. 12:2-11 (1995).
Baselga et al., “Phase II Study of Weekly Intravenous Recombinant Humanised Anti-p185HER2Monoclonal Antibody in Patients With HER2
eu-Overexpressing Metastatic Breast Cancer”J. Clin. Oncol. 14(3):737-744 (Mar. 1996).
Beauvais et al., “Both Glassy State and Native Structure are Required for Storage Stability of Lyophilized Interleukin-1 Receptor Antagonist”Pharm. Res. (Abstract #2007) 12(9):S-80 (1995).
Boulet et al., “Inhibitory Effects of an Anti-IgE Antibody E25 on Allergen-induced Early Asthmatic Response”Am J Respir Crit Care Med155:1835-1840 (1997).
Burton et al., “L

Affiliated with

Also associated with

Rating

Protein formulation does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Protein formulation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Protein formulation will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-3672724