STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION OF IGG ANTIBODIES - Patent Pending

(12) Patent Application: (11) CA 2454587
ABSTRACT:
This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more,of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5,about 0.005 % - 0.03 % polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, andis suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal,or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.
(72) Inventors (Country): KAISHEVA, ELIZABET A. (United States)
GUPTA, SUPRIYA (United States)
FLORES-NATE, ALENI (United States)
(73) Owners (Country): PROTEIN DESIGN LABS, INC. (United States)
(71) Applicants (Country): PROTEIN DESIGN LABS, INC. (United States)
(74) Agent: OGILVY RENAULT
(45) Issued:
(86) PCT Filing Date: July 25, 2002
(87) PCT Publication Date: Feb. 6 , 2003
(51) International Class (IPC): C07K 16/00
A61K 39/395
Patent Cooperation Treaty (PCT): Yes (85) National Entry: Jan. 21, 2004
(86) PCT Filing number: PCT/US2002/024078
(87) International publication number: WO2003/009817
(30) Application priority data: Application No. Country Date
60/307,878 United States July 25, 2001
Availability of licence: N/A
Language of filing: English