Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Lymphokines – e.g. – interferons – interlukins – etc.
Reexamination Certificate
2007-05-18
2009-08-11
Bunner, Bridget E (Department: 1647)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Lymphokines, e.g., interferons, interlukins, etc.
C514S012200, C514S002600, C424S085400
Reexamination Certificate
active
07572893
ABSTRACT:
Formulations of an interleukin-1 (IL-1) antagonist are provided including a pre-lyophilized formulation, a reconstituted lyophilized formulation, and a stable liquid formulation. Preferably, the IL-1 antagonist is an IL-1 trap composed of a dimer of two fusion protein having an amino acid sequence selected from the group consisting of SEQ ID NO: 10.
REFERENCES:
patent: 5399670 (1995-03-01), Bhattacharya et al.
patent: 6267958 (2001-07-01), Andya et al.
patent: 6875432 (2005-04-01), Liu et al.
patent: 7001892 (2006-02-01), Chmielewski et al.
patent: 7060268 (2006-06-01), Andya et al.
patent: 2003/0113316 (2003-06-01), Kaisheva et al.
patent: 2003/0143697 (2003-07-01), Stahl et al.
patent: 2006/0217311 (2006-09-01), Dix et al.
patent: WO93/00807 (1993-01-01), None
Daugherty and MRSNY, 2006, “Formulation and delivery issues for monoclonal antibody therapeutics.”, Advanced Drug Delivery Reviews 58: 686-706.
Katayama et al., 2004, “Retrospective statistical analysis of lyophilized protein formulations of progenipoietin using PLS: Determination of the critical parameters for long-term storage stability.” Jour. Pharm. Sci. 93(10): 2609-2623.
Carpenter et al., 1997, “Rational design of stable lyophilized protein formulations: Some practical advice.” Pharm. Research 14(8): 969-975.
Chang et al., 1996, “Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: Glass transition and protein conformation.” Arch. Biochem. Biophys. 331(2): 249-258.
Webb et al., 2001, “A new mechanism for decreasing aggregation of recombinant human interferon-gama by a surfactant: Slowed dissolution of lyophilized formulations in a solution containing 0.03% polysorbate 20.” Jour. Pharm. Sci. 91(2): 543-558.
Wang, 1999, “Instability, stabilization, and formulation of liquid protein pharmaceuticals.” International Jour. Pharmceutics 185: 129-188.
Sharma and Kalonia, 2004, “Polyethylene glycol-induced precipitation of interferon alpha-2a followed by vacuum drying: development of a novel process for obtaining a dry, stable powder.” AAPS PharmSci. 6(1):1-14.
Chang et al, 1996, “Development of a stable freeze-dried formulation of recombinant human interleukin-1 receptor antagonist.” Pharm. Research 13(2): 243-249.
Bowers Katherine
Dix Daniel
Goolcharran Chimanlall
Lin Leu-Fen H.
Bunner Bridget E
Gregg, Esq. Valeta
Hamud Fozia M
Regeneron Pharmaceuticals Inc.
Smeland, Esq. Tor
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