Stabilized liquid anti-RSV antibody formulations

Details Stabilized liquid anti-RSV antibody formulations Stabilized liquid anti-RSV antibody formulations

2007-11-13

2007-11-13

Navarro, Mark (Department: 1645)

Drug, bio-affecting and body treating compositions

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

C424S141100, C424S147100, C424S159100

Reexamination Certificate

active

11362267

ABSTRACT:
The present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof that immunospecifically bind to a respiratory syncytial virus (RSV) antigen, which formulations exhibit stability, low to undetectable levels of aggregation, and very little to no loss of the biological activities of SYNAGIS® or an antigen-binding fragment thereof, even during long periods of storage. In particular, the present invention provides liquid formulations of SYNAGIS® or an antigen-binding fragment thereof which immunospecifically binds to a RSV antigen, which formulations are substantially free of surfactant, inorganic salts, and/or other common excipients. Furthermore, the invention provides method of preventing, treating or ameliorating symptoms associated with RSV infection utilizing liquid formulations of the present invention.

REFERENCES:
patent: 4360457 (1982-11-01), Ono et al.
patent: 4374763 (1983-02-01), Takagi
patent: 4526938 (1985-07-01), Churchill et al.
patent: 4597966 (1986-07-01), Zolton et al.
patent: 4703039 (1987-10-01), Hawiger et al.
patent: 4800078 (1989-01-01), Ladner et al.
patent: 4880078 (1989-11-01), Inoue et al.
patent: 4992419 (1991-02-01), Woog et al.
patent: 5128326 (1992-07-01), Balazs et al.
patent: 5223409 (1993-06-01), Ladner et al.
patent: 5290540 (1994-03-01), Prince et al.
patent: 5403484 (1995-04-01), Ladner et al.
patent: 5571698 (1996-11-01), Ladner et al.
patent: 5585089 (1996-12-01), Queen et al.
patent: 5608038 (1997-03-01), Eibl et al.
patent: 5679377 (1997-10-01), Bernstein et al.
patent: 5693762 (1997-12-01), Queen et al.
patent: 5739277 (1998-04-01), Presta et al.
patent: 5747035 (1998-05-01), Presta et al.
patent: 5762905 (1998-06-01), Burton et al.
patent: 5811524 (1998-09-01), Brams et al.
patent: 5824307 (1998-10-01), Johnson et al.
patent: 5840298 (1998-11-01), Brams et al.
patent: 5855913 (1999-01-01), Hanes et al.
patent: 5866125 (1999-02-01), Brams et al.
patent: 5869046 (1999-02-01), Presta et al.
patent: 5871736 (1999-02-01), Bruegger et al.
patent: 5874064 (1999-02-01), Edwards et al.
patent: 5912015 (1999-06-01), Bernstein et al.
patent: 5916597 (1999-06-01), Lee et al.
patent: 5934272 (1999-08-01), Lloyd et al.
patent: 5939068 (1999-08-01), Brams et al.
patent: 5955364 (1999-09-01), Brams et al.
patent: 5958765 (1999-09-01), Brams et al.
patent: 5961927 (1999-10-01), Isaacs et al.
patent: 5985309 (1999-11-01), Edwards et al.
patent: 5985320 (1999-11-01), Edwards et al.
patent: 5989463 (1999-11-01), Tracy et al.
patent: 6019968 (2000-02-01), Platz et al.
patent: 6096551 (2000-08-01), Barbas et al.
patent: 6165745 (2000-12-01), Ward et al.
patent: 6171586 (2001-01-01), Lam et al.
patent: 6277375 (2001-08-01), Ward
patent: 6537809 (2003-03-01), Brams
patent: 6565849 (2003-05-01), Koenig
patent: 6572856 (2003-06-01), Taylor et al.
patent: 6586008 (2003-07-01), Batycky et al.
patent: 6656467 (2003-12-01), Young et al.
patent: 6685942 (2004-02-01), Burton et al.
patent: 6818216 (2004-11-01), Young et al.
patent: 6855493 (2005-02-01), Young et al.
patent: 7132100 (2006-11-01), Oliver et al.
patent: 2001/0034062 (2001-10-01), Koenig
patent: 2002/0004046 (2002-01-01), Johnson
patent: 2002/0018780 (2002-02-01), Koenig et al.
patent: 2002/0051787 (2002-05-01), Prince et al.
patent: 2002/0098189 (2002-07-01), Young et al.
patent: 2002/0102257 (2002-08-01), Johnson
patent: 2002/0177126 (2002-11-01), Young et al.
patent: 2003/0190311 (2003-10-01), Johnson et al.
patent: 2004/0005324 (2004-01-01), Pilkington et al.
patent: 2004/0018200 (2004-01-01), Oliver et al.
patent: 2004/0018243 (2004-01-01), Basu et al.
patent: 2004/0202721 (2004-10-01), Lipp et al.
patent: 2005/0147616 (2005-07-01), Young et al.
patent: 0 025 321 (1981-03-01), None
patent: 0 025 719 (1981-03-01), None
patent: 0 368 684 (1990-05-01), None
patent: 0 420 649 (1990-09-01), None
patent: 0 413 622 (1991-02-01), None
patent: 0 327 378 (1996-12-01), None
patent: 1 314 437 (2003-05-01), None
patent: 2758331 (1998-07-01), None
patent: 1268646 (1989-10-01), None
patent: WO 89/07142 (1989-08-01), None
patent: WO 91/04743 (1991-04-01), None
patent: WO 91/05548 (1991-05-01), None
patent: WO 91/14438 (1991-10-01), None
patent: WO 92/19244 (1992-11-01), None
patent: WO 93/15199 (1993-08-01), None
patent: WO 93/15200 (1993-08-01), None
patent: WO 93/22332 (1993-11-01), None
patent: WO 94/06448 (1994-03-01), None
patent: WO 96/05229 (1996-02-01), None
patent: WO 96/20698 (1996-07-01), None
patent: WO 96/32478 (1996-10-01), None
patent: WO 97/32572 (1997-09-01), None
patent: WO 97/34631 (1997-09-01), None
patent: WO 97/43316 (1997-11-01), None
patent: WO 97/44013 (1997-11-01), None
patent: WO 97/45140 (1997-12-01), None
patent: WO 98/23289 (1998-06-01), None
patent: WO 98/31346 (1998-07-01), None
patent: WO 98/56418 (1998-12-01), None
patent: WO 99/15154 (1999-04-01), None
patent: WO 99/20253 (1999-04-01), None
patent: WO 99/43713 (1999-09-01), None
patent: WO 99/66903 (1999-12-01), None
patent: WO 00/09560 (2000-02-01), None
patent: WO 00/10541 (2000-03-01), None
patent: WO 00/29584 (2000-05-01), None
patent: WO 01/55217 (2001-08-01), None
patent: WO 01/64751 (2001-09-01), None
patent: WO 01/77137 (2001-10-01), None
patent: WO 02/060919 (2001-12-01), None
patent: WO 02/13860 (2002-02-01), None
Wang Wei, “Instability, stabilization, and formulation of liquid protein pharmaceuticals,”Int. J. Pharmaceutics185:129-188 (Aug. 20, 1999).
Abman et al., 1988, “Role of respiratory syncytial virus in early hospitalizations for respiratory distress of young infants with cystic fibrosis,” J. Pediatr. 113(5):826-830.
Ahouse et al., 1993, “Mouse MHC class I-like Fc receptor encoded outside the MHC,”J. Immunol.151(11):6076-6088.
American Academy of Pediatrics, 2000, “Summaries of Infectious Diseases,” in: 2000Red Book: Report of the Committee on Infectious Diseases, 25thed., Pickering, ed., Elk Grove Village, IL pp. 483-487.
American Academy of Pediatrics Committee on Infectious Diseases, 1993, “Use of ribavirin in the treatment of respiratory syncytial virus infection,” Pediatrics 92(3):501-504.
Anderson et al., 1985, “Microneutralization test for respiratory syncytial virus based on an enzyme immunoassay,” J. Clin. Microbiol. 22:1050-1052.
Beeler et al., 1989, “Neutralization epitopes of the F glycoprotein of respiratory syncytial virus: effect of mutation upon fusion function,” J. Virol. 63(7):2941-2950.
Bentley et al., 1980, “Human immunoglobulin variable region genes—DNA sequences of two V kappa genes and a pseudogene,” Nature 288(5792):730-733.
Borvak et al., 1998, “Functional expression of the MHC class I-related receptor, FcRn, in endothelial cells of mice,” Int. Immunol. 10(9):1289-1298.
Botts et al., 1984, “On the mechanism of energy transduction in myosin subfragment 1,” Proc. Natl. Acad. Sci. USA 81(7):2060-2064.
Boulianne et al., 1984, “Production of functional chimaeric mouse/human antibody,” Nature 312(5995):643-646.
Burmeister et al., 1994, “Crystal structure at 2.2 A resolution of the MHC-related neonatal Fc receptor,” Nature 372(6504):336-343.
Burmeister et al., 1994, “Crystal structure of the complex of rat neonatal Fc receptor with Fc,” Nature 372(6504):379-383.
Byrd et al., 1997, “Animal models of respiratory syncytial virus infection,” Clin. Infect. Dis. 25(6):1363-1368.
Carson et al., 1986, “Human lymphocyte hybridomas and monoclonal antibodies,” Adv. Immunol. 38:275-311.
Chintalacharuvu et al., 2001, “Hybrid IgA2/IgG1 antibodies with tailor-made effector functions,” Clin. Immunol. 101(1):21-31.
Cianga et al., 1999, “Identification and function of neonatal Fc receptor in mammary gland of lactating mice,” Eur. J. Immunol. 29(8):2515-2523.
Cleek et al., 1997, “Biodegradable Polymeric Carriers for bFGF Antibody for Cardiovascular Application,” Pro. Int'l Symp. Control. Rel Bioact. Mater. 24:8

Affiliated with

Also associated with

Rating

Stabilized liquid anti-RSV antibody formulations does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Stabilized liquid anti-RSV antibody formulations, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Stabilized liquid anti-RSV antibody formulations will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-3840089