Method of making CS6 antigen vaccine for treating,...

Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Using a micro-organism to make a protein or polypeptide

Reexamination Certificate

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C435S069300, C435S069100, C435S252200, C435S848000

Reexamination Certificate

active

10370522

ABSTRACT:
Disclosed herein are methods for making large amounts of highly pure colonization factors. The methods of the present invention differ from prior art methods in that host cells which express the colonization factor of interest are cultured in media comprising more than about 50 μg/l of an antibiotic, the media is centrifuged and then filtered with a 0.2 μm filter tangential flow cartridge and a 300,000 MW cut-off filter, and a divalent cation is added. As disclosed herein the colonization factors made by the method of the present invention may be used in pharmaceutical compositions and methods for treating or preventing enterotoxigenicEscherichia coliinfections.

REFERENCES:
patent: 5648081 (1997-07-01), van den Bosch
patent: 5698416 (1997-12-01), Wolf et al.
patent: 5830479 (1998-11-01), Emery et al.
patent: 5914114 (1999-06-01), Cassels
patent: 5935838 (1999-08-01), Askelöf et al.
patent: 6309669 (2001-10-01), Setterstrom et al.
patent: 6902736 (2005-06-01), Altboum et al.
patent: 2004/0156829 (2004-08-01), Wolf et al.
patent: WO 02/064162 (2002-08-01), None
Helander et al. J. Clin. Microbiol. 35: 867-872, 1997.
Jones et al. J. Bacteriol. 146: 841-846, 1981.
Cassels et al. Toxicon 36 (9): pp. 1231, Sep. 1998.
Wolf (1997) “Occurrence, Distribution, and Associations of O and H Serogroups, Colonization Factor Antigens, and Toxins of EnterotoxigenicEscherichia coli”, Clinical Microbiology Reviews, 10(4):569-584.
Cassels, et al. (1998) “Production and microencapsulation of enterotoxigenicEscherichia colicolonization factors in human use vaccines” Abstracts of the General Meeting of the Am. Society for Microbiology, Atlanta, GA, Abstract E-92.
Katz, et al. (2001) “Clinical evaluation of microencapsulated CS6 vaccine for enterotoxigenicEscherichia coli(ETEC) diarrhea in healthy adults” Vaccines for Enteric Diseases Ved, 7-9.
Katz, et al. (2003) “Oral immunization of adult volunteers with microencapsulated enterotoxigenicEscherichia coli(ETEC) CS6 antigen” Vaccine, Buterworth Scientific, Guilford, GB, 21(5-6):341-346.
Supplementary Partial EP Search Report mailed from EPO May 6, 2005.

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