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24/06/2005 - Controller General of Patents, Designs, and Trade Marks

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(21) Application No. IN/PCT/2001/125/DEL A (22) Date <strong>of</strong> filing <strong>of</strong> Application: 12/02/2001<br />

(54) Title <strong>of</strong> the invention: “PROCESS FOR THE PREPARATION OF ACTIVE SOMATOTROPIN<br />

FROM INCLUSION BODIES.”<br />

(51) International Classification 7 : C 07K 14/61, 1/00, C 12P 21/02<br />

(30) Priority Data :<br />

(31) Document No.: 1998-34910<br />

(32) Date : 27/08/1998<br />

(33) Name <strong>of</strong> convention country : KOREA<br />

(66) Filed U/s 5(2) : NIL<br />

(61) Patent <strong>of</strong> addition to application No. : NA<br />

(62) Filed on : NA<br />

(63) Divisional to Application No. :NIL<br />

(64) Filed on : NA<br />

(57) Abstract:<br />

(71) Name <strong>of</strong> the applicant:<br />

LG CHEMICL LIMITED.<br />

Address <strong>of</strong> the Applicant:<br />

20, Yoido-dong, Yongdungpogu,<br />

Seoul 150-721, Korea.<br />

(72) Name <strong>of</strong> the Inventor:<br />

LEE YONG-JUN<br />

LEE HONG-KYUN<br />

HAN KYUBOEM<br />

A process for the preparation <strong>of</strong> biologically active form <strong>of</strong> a somatotropin protein from inclusion<br />

bodies <strong>of</strong> a recombinant host cell containing an inactive form <strong>of</strong> said somatotropin protein, which<br />

is characterized by comprises the steps <strong>of</strong>:<br />

(a) contacting the inclusion bodies with an aqueous solution containing an alcohol at an<br />

alkaline pH ranging from 9 to 13 to solubilize said somatotropin protein;<br />

(b) decreasing the concentration <strong>of</strong> the alcohol in the aqueous solution;<br />

(c) bringing the aqueous solution into contact with a mild oxidizing agent to refold <strong>and</strong> form<br />

intramolecular disulfide bonds between cysteine residues <strong>of</strong> said somatotropin protein; <strong>and</strong><br />

(d) optionally adding in either step (a) or step (c), or in both steps (a) <strong>and</strong><br />

(e) a reducing agent as such as herein described,<br />

wherein steps (a) <strong>and</strong> (c) are performed at a temperature ranging from 0 to 50 o C.<br />

18231

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