Abstract: Disclosed is a method for producing hyaluronidase or a variant thereof. Specifically, the method is capable of changing the N-glycan levels under culture conditions including a controlled concentration of glucose in the culture medium and a decreased culture temperature for a specific culture time period, thereby increasing the specific activity by 10% or more and improving the quality and production yield.

Abstract: Disclosed is a pharmaceutical composition containing (a) a drug, (b) a hyaluronidase PH20 or its variant, and (c) a poloxamer-based surfactant. A human PH20 variant contained in the pharmaceutical composition may includes substitution of one or more amino acids at one or more regions selected from an alpha helix 8 sequence (S347 to C381) and a linker (A333 to R346) between alpha helix 7 and alpha helix 8 in a wild-type human PH20 having a sequence of SEQ ID NO: 1 and optionally includes truncation of one or more amino acids at an N-terminus and/or C-terminus in the wild-type human PH20 having a sequence of SEQ ID NO: 1. In addition, the pharmaceutical composition further contains a pharmaceutically acceptable additive, particularly a stabilizer.

Abstract: The present disclosure relates to an antibody-drug conjugate in which a modified antibody comprising a motif having a specific structure at the end of the antibody is conjugated to a drug via a linker, and a composition comprising the same, and more particularly to a modified antibody-drug conjugate (mADC) comprising a modified antibody that has a significantly increased conjugation yield of drug due to a motif bound to the heavy chain or light chain C-terminus of the antibody, and to a composition comprising the same.

Abstract: The present invention relates to a growth hormone receptor antagonist comprising a growth hormone variant which is modified by substitution of one or more amino acids of growth hormone. Further, the growth hormone receptor antagonist of the present invention may further comprise a long-acting carrier which is fused to the growth hormone variant. The growth hormone receptor antagonist may have strong binding potency to growth hormone receptor and may exhibit a long-lasting antagonistic action.

Abstract: A modified antibody that binds specifically to folate receptor alpha (FOLR1) and blocks the activity of FOLR1 with an increased binding affinity, an antigen-binding fragment thereof, a composition containing the antibody or fragment, and their uses are disclosed. The modified antibody or antigen-binding fragment thereof may be used for the prevention or treatment of cancer proliferative disorder associated with an increased FOR1 expression, and may also be used for diagnosis of the disease. The proliferative disorder may be cancer.

Abstract: The present invention relates to a method for preparing a fusion protein having an IgG Fc domain and, specifically, to a method for preparing a fusion protein having an IgG Fc domain, the method additionally comprising a step of culturing cells, which produce the fusion protein, at a decreased culture temperature, thereby increasing cell growth and cell viability so as to increase fusion protein productivity and inhibiting aggregate generation so as to improve quality and production yield.

Abstract: The present invention relates to a method for preparing a fusion protein having an IgG Fc domain and, specifically, to a method for preparing a fusion protein having an IgG Fc domain, the method additionally comprising a step of culturing cells, which produce the fusion protein, at a decreased culture temperature, thereby increasing cell growth and cell viability so as to increase fusion protein productivity and inhibiting aggregate generation so as to improve quality and production yield.

Abstract: The present disclosure relates to an antibody-drug conjugate in which a modified antibody comprising a motif having a specific structure at the end of the antibody is conjugated to a drug via a linker, and a composition comprising the same, and more particularly to a modified antibody-drug conjugate (mADC) comprising a modified antibody that has a significantly increased conjugation yield of drug due to a motif bound to the heavy chain or light chain C-terminus of the antibody, and to a composition comprising the same.

Abstract: A modified antibody that binds specifically to folate receptor alpha (FOLR1) and blocks the activity of FOLR1 with an increased binding affinity, an antigen-binding fragment thereof, a composition containing the antibody or fragment, and their uses are disclosed. The modified antibody or antigen-binding fragment thereof may be used for the prevention or treatment of cancer proliferative disorder associated with an increased FOR1 expression, and may also be used for diagnosis of the disease. The proliferative disorder may be cancer.

Abstract: The present invention relates to a method for preparing a fusion protein having an IgG Fc domain and, specifically, to a method for preparing a fusion protein having an IgG Fc domain, the method additionally comprising a step of culturing cells, which produce the fusion protein, at a decreased culture temperature, thereby increasing cell growth and cell viability so as to increase fusion protein productivity and inhibiting aggregate generation so as to improve quality and production yield.

Abstract: A stable liquid formulation includes a fusion protein having an Fc domain of a human immunoglobulin G (IgG), in particular, a protein in which an Fc domain of a human immunoglobulin G (IgG) and a soluble extracellular domain of a vascular endothelial growth factor (VEGF) receptor are fused (e.g., aflibercept)). A composition for stabilizing a protein and a method for stabilizing a protein in which an Fc domain of an IgG and a soluble extracellular domain of a VEGF receptor are fused are disclosed. The present invention improves therapeutic effects on various ophthalmic diseases (e.g., retinal vein occlusion, diabetic macular edema, choroidal neovascularization and wet age-related macular degeneration, etc.) caused by abnormal angiogenesis, while pursuing stabilization of bioactivity through a stable liquid formulation suitable for intravitreal injection of an anti-VEGF-Fc fusion protein including aflibercept.

Abstract: 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.

Abstract: The present invention relates to a composition for stabilizing TNF?-binding protein exhibiting physiological activity, and more specifically, to a composition for stabilizing protein including basic amino acid and sugar and/or ammonium salt, a pharmaceutical formulation including the same, and a method for stabilizing TNF?-binding protein. The formulation including basic amino acid; and sugar and/or ammonium salt according to the present invention effectively inhibits aggregation, denaturation and oxidation of TNF?-binding protein used for treating various diseases, for example, an anti-TNF-alpha antibody, such that the protein is capable of being preserved and stored for a long time, which is widely usable and effective in a medical field using TNF?-binding protein, for example, an anti-TNF-alpha antibody.

Abstract: The present invention relates to an antibody in which a motif composed of an amino acid or peptide sequence including one or more cysteine residues is bound to the terminus of a parent antibody, particularly the terminus of the heavy chain of the parent antibody. Also, the present invention relates to a modified antibody-drug conjugate (mADC) comprising a drug bound to the antibody, and a method for producing the antibody or the modified antibody-drug conjugate. The modified antibody-drug conjugate according to the invention can accurately deliver the drug to a target cell due its high specificity to antigen, and thus can increase the therapeutic effect of the drug. Also, it can increase the usability of drugs, particularly anticancer drugs, the use of which is restricted due to their toxicity, despite their high efficacy. Moreover, the invention relates to a composition for treatment of diseases, particularly cancers, which comprise the modified antibody-drug conjugate.

Abstract: The present invention relates to an antibody in which a motif composed of an amino acid or peptide sequence including one or more cysteine residues is bound to the terminus of a parent antibody, particularly the terminus of the heavy chain of the parent antibody. Also, the present invention relates to a modified antibody-drug conjugate (mADC) comprising a drug bound to the antibody, and a method for producing the antibody or the modified antibody-drug conjugate. The modified antibody-drug conjugate according to the invention can accurately deliver the drug to a target cell due its high specificity to antigen, and thus can increase the therapeutic effect of the drug. Also, it can increase the usability of drugs, particularly anticancer drugs, the use of which is restricted due to their toxicity, despite their high efficacy. Moreover, the invention relates to a composition for treatment of diseases, particularly cancers, which comprise the modified antibody-drug conjugate.

Abstract: The present invention relates to a composition for stabilizing a fusion protein of a physiologically active protein and an Fc domain, and more particularly to a method of stabilizing a fusion protein of a protein and an Fc domain using a composition containing an ammonium salt or a combination of an ammonium salt and succinate. The composition containing an ammonium salt or a combination of an ammonium salt and succinate according to the present invention can effectively inhibit the aggregation of the protein-Fc domain fusion protein, and thus enables the fusion protein to be stored for a long period of time. Accordingly, the composition can be widely used in the medical field that uses the protein-Fc domain fusion protein.

Abstract: The present invention relates to an antibody in which a motif composed of an amino acid or peptide sequence including one or more cysteine residues is bound to the terminus of a parent antibody, particularly the terminus of the heavy chain of the parent antibody. Also, the present invention relates to a modified antibody-drug conjugate (mADC) comprising a drug bound to the antibody, and a method for producing the antibody or the modified antibody-drug conjugate. The modified antibody-drug conjugate according to the invention can accurately deliver the drug to a target cell due its high specificity to antigen, and thus can increase the therapeutic effect of the drug. Also, it can increase the usability of drugs, particularly anticancer drugs, the use of which is restricted due to their toxicity, despite their high efficacy. Moreover, the invention relates to a composition for treatment of diseases, particularly cancers, which comprise the modified antibody-drug conjugate.

Abstract: 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 (t1/2) 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 1st and 25th positions 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.

Abstract: 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.

Abstract: 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 (t1/2) 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 1st and 25th positions 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.