Alteogen, Inc.

Cj Healthcare Corporation

Sang Mee Lee

Soon Jae Park

Hye-Shin Chung

Sang Hyun Lee

Young Joon Park

Dong Eok Lee

Jee Won Ahn

Ki Wan Kim

Ji-Sun Kim

Chi Hye Park

Hyoung Taek Lim

Ji Hyun Moon

Ji Sun Kim

Hye Shin Chung

Yoon Jung Lee

Won Jeong Lee

Chung Min Lee

Hoo Keun Oh

Chang Bong Jun

Gil Bu Kang

Sung Yoo Cho

Seung Bum Yoo

The present invention relates to a long-acting human growth hormone NexP-hGH protein and its production method. More specifically, it relates to a specific isoform of long-acting human growth hormone NexP-hGH protein in which human growth hormone is fused with a highly glycosylated alpha-1 antitrypsin mutant whereby long-acting properties in vivo are increased. The present invention also relates to a high-purity purification method for NexP-hGH, which includes the steps of: (a) carrying out anion-exchange resin chromatography on a biological emulsion comprising NexP-hGH in which human growth hormone is fused with an alpha-1 antitrypsin mutant; (b) carrying out hydrophobic resin chromatography on the biological emulsion comprising NexP-hGH, or on the eluate produced in step (a); and (c) carrying out affinity chromatography, entailing packing with a resin to which anti-alpha-1 antitrypsin antibody fragments are attached, on the biological emulsion comprising NexP-hGH and on the eluate produced in step (a) or step (b).

Method of purifying a long-acting human growth hormone

A novel alpha-1 antitrypsin variant, a method of preparing the same, and use thereof are provided. The alpha-1 antitrypsin variant has excellent stability in the body and maintains an inhibitory effect on elastase activities because the blood half-life (t) and the area under blood drug concentration vs. time curve (AUC) are remarkably increased by adding an N-glycosylation site in animal cells through amino acid mutation between 1and 25positions of the N-terminus of alpha-1 antitrypsin. Therefore, the alpha-1 antitrypsin variant can be useful in preventing or treating alpha-1 antitrypsin deficiency.

Alpha-1 antitrypsin variant, preparation method thereof and use thereof

The present invention relates to a fusion protein or peptide, the in vivo half-life of which is increased by maintaining in vivo sustained release, and to a method for increasing in vivo half-life using same. A fusion protein or peptide according to the present invention has excellent in vivo stability by binding a physiologically active protein or physiologically active peptide to an alpha-1 antitrypsin or alpha-1 antitrypsin mutant with one or more amino acids mutated to maintain the in vivo sustained release and to significantly increase the half-life thereof in blood (T1/2) compared to an inherent physiologically active protein or physiologically active peptide. Thus, a fusion protein or peptide according to the present invention can be useful in developing a sustained-release preparation of a protein or peptide drug.

In vivo half life increased fusion protein or peptide maintained by sustained in vivo release, and method for increasng in vivo half-life using same

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Daejeon, South Korea

Sang Mee Lee