STABILE ISOTONIC LYOPHILIZED PROTEIN FORMULATION - Press Releases

12) Patent Application: (11) CA 2226575
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.
(72) Inventors (Country): WU, SYLVIA SAU-YAN (United States)
CLELAND, JEFFREY L. (United States)
ANDYA, JAMES (United States)
HSU, CHUNG C. (United States)
YANG, JANET YU-FENG (United States)
OVERCASHIER, DAVID E. (United States)
SHIRE, STEVEN J. (United States)
LAM, XANTHE M. (United States)

(73) Owners (Country): GENENTECH, INC. (United States)
(71) Applicants (Country): GENENTECH, INC. (United States)
(74) Agent: DENNISON ASSOCIATES
(45) Issued:
(86) PCT Filing Date: July 23, 1996
(87) PCT Publication Date: Feb. 13, 1997
Examination requested: July 8 , 2003
(51) International Class (IPC): A61K 38/16
A61K 9/19
A61K 47/26
A61K 39/395
Patent Cooperation Treaty (PCT): Yes (85) National Entry: Jan. 12, 1998
(86) PCT Filing number: PCT/US1996/012251
(87) International publication number: WO1997/004801
(30) Application priority data: Application No. Country Date
08/508014 United States July 27, 1995
08/615369 United States Mar. 14, 1996
Availability of licence: N/A
Language of filing: English