Glycoprotein and process for producing the same

Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Recombinant dna technique included in method of making a...

Reexamination Certificate

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C435S006120, C435S071100

Reexamination Certificate

active

07579166

ABSTRACT:
A process for producing a lysosomal enzyme having a mannose-6-phosphate-containing acidic sugar chain, wherein the process comprising: culturing in a medium yeast cells obtained by introducing a lysosomal enzyme gene into a sugar chain biosynthetic enzyme gene mutant strain of yeast, collecting a lysosomal enzyme having a phosphate-containing sugar chain from the culture, and then treating the enzyme with α-mannosidase; and pharmaceutical compositions for treatment of human lysosomal enzyme deficiencies produced by the process. The genetic engineering technique using the yeast according to the present invention allows large-amount and high-purity production of a glycoprotein having a phosphate-containing acidic sugar chain which can serve as a labeling marker for transporting into lysosomes in cells of mammals such as human. The glycoprotein having a phosphate-containing acidic sugar chain according to the invention may be utilized as a drug effective in treatment of human lysosomal enzyme deficiencies, etc.

REFERENCES:
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patent: 5854031 (1998-12-01), Nakayama et al.
patent: 1 211 310 (2002-06-01), None
patent: WO 01/19955 (2001-03-01), None
Supplementary European Search Report of EP 02 73 6110.
K. Takegawa et al., “Purification and Properties of a Low-Molecular-Weight Alpha Mannosidase FromCellulomonas-sp”, Journal of Fermentation and Bioengineering, vol. 69, No. 2, 1990, pp. 129-131.
Yasunori Chiba et al., “Production in yeast of α-galactosidase-A, a lysosomal enzyme applicable to enzyme replacement therapy for Fabry disease”, Glycobiology, vol. 12, No. 12, pp. 821-828, 2002.
JP 3091851 B2 (Director General, Agency of Industrial Science and Tehcnology) Jul. 28, 2000.
JP 10-155495 A (Director General, Agency of Industrial Science and Technology) Jun. 16, 1998.
R. Schiffman, et al., Infusion of α-galactosidase A reduces tissue globotriaosylceramide storage in patients with Fabry disease. Proc. Natl. Acad. Sci. USA, Jan. 2000, vol. 97, No. 1, pp. 365-370.

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