Hanmi Science Co., Ltd.

Hanmi Pharm. Co., Ltd.

Byung Sun Lee

Se Chang Kwon

Sung H Hong

Jae Min Lee

Chang Hwan Kim

Sung Youb Jung

Jin Young Kim

Sung Min Bae

Sung Kap Hong

Dae Jin Kim

In Young Choi

Hyun Uk Kim

Seung Su Kim

Dae Seong Im

Sang Youn Hwang

Mi Ji Lee

Yong Ho Huh

Soo Young Kwak

Hee Chul Kang

Disclosed is a liquid formulation which allows long-acting G-CSF conjugates, that have improved in vivo duration and stability, to be stable when stored for a long period of time. It comprises a stabilizer composition characterized by buffer and mannitol. Being free of human serum albumin and other potential factors harmful to the body, the liquid formulation is free of concerns about viral infections and guarantees excellent storage stability to long-acting G-CSF conjugates.

Liquid formulations for long-acting G-CSF conjugate

A blood coagulation factor VII derivative, a blood coagulation factor VIIa derivative, FacVII and FacVIIa conjugates are prepared by linking a polymer capable of extending the blood half-life to the derivative. FacVII and VIIa complexes each prepared by linking a carrier to the conjugate, genes encoding the FacVII and FacVIIa derivatives, expression vectors comprising the genes, transformants introduced with the expression vectors, a method for preparing the FacVII and FacVIIa derivatives using the transformants, a method for preparing the FacVIIa conjugate and complex, a FacVIIa complex prepared by the method, a pharmaceutical composition for the prevention or treatment of hemophilia comprising the derivative, conjugate, or complex as an active ingredient, and a pharmaceutical composition for blood coagulation comprising the derivative, conjugate, or complex as an active ingredient are described.

Blood coagulation factor VII and VIIa derivatives, conjugates and complexes comprising the same, and use thereof

A method for the mass production of human coagulation Factor VII. The method includes a) providing an expression vector carrying i) a dihydrofolate reductase promoter devoid of one or more CCGCC repeat sequences from the GC-rich region thereof and a dihydrofolate reductase (DHFR) gene operably linked thereto and ii) a cytomegalovirus (CMV) promoter and a human coagulation Factor VII gene operably linked thereto; b) obtaining a transformed host cell line containing the expression vector; and c) culturing the transfected host cell in the presence of a dihydrofolate reductase inhibitor to select cells which express human coagulation Factor VII with high efficiency; and d) adding sodium butyrate to the selected host cells.

Method for mass production of factor VII/VIIA

The present invention relates to a long-acting human follicle-stimulating hormone formulation having improved in vivo duration and stability, comprising a human follicle-stimulating hormone conjugate that is prepared by covalently linking human follicle-stimulating hormone with an immunoglobulin Fc region via a non-peptidyl polymer, and a preparation method thereof. The long-acting human follicle-stimulating hormone formulation of the present invention maintains in vivo activity of human follicle-stimulating hormone at a relatively high level and remarkably increases the serum half-life thereof.

Long-acting human follicle-stimulating hormone formulation using immunoglobulin fragment

Disclosed is a liquid formulation of long-acting human growth hormone (hGH) conjugate, free of albumin, which can guarantee the stability of the long-acting hGH conjugate when stored over a long period of time, wherein the long-acting human growth hormone conjugate includes a human growth hormone linked to an immunoglobulin Fc region, and has a prolonged in vivo stability compared to the native form. The liquid formulation of hGH conjugate including a pH 5.0&#x2dc;6.0 buffer, a sugar alcohol, a salt and a non-ionic surfactant is free of human serum albumin and other hazardous factors which are potentially contaminated with viruses, and can provide excellent storage stability customized for a long-acting hGH conjugate composed of an hGH polypeptide and an immunoglobulin Fc region which has higher molecular weight and in vivo durability, compared to the native.

Liquid formulation of long-acting human growth hormone conjugate

Growing community of inventors

Seoul, South Korea

Byung Sun Lee