Chemistry: molecular biology and microbiology – Micro-organism – tissue cell culture or enzyme using process... – Enzymatic production of a protein or polypeptide
Patent
1997-09-08
2000-01-04
Woodward, Michael P.
Chemistry: molecular biology and microbiology
Micro-organism, tissue cell culture or enzyme using process...
Enzymatic production of a protein or polypeptide
424 945, 424 946, 435193, 514 2, 530350, 530351, C12P 2100
Patent
active
060108711
DESCRIPTION:
BRIEF SUMMARY
INDUSTRIAL FIELD OF THE INVENTION
This invention relates to a process for modifying a physiologically-active peptide or protein, and to modified products of the process.
PRIOR ART
Many physiologically-active peptides and proteins are known. Hereinunder these peptides and proteins will be generically referred to as physiologically-active peptides.
Such physiologically-active peptides include, for example, peptides that physiologically act in-vivo, such as interleukin (IL)-1, -2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -12, -13, -14 and -15, G-CSF, GM-CSF, M-CSF, erythropoietin, stem cell factor, mpl-ligand, .alpha.-, .beta.- and .gamma.-interferons, somatostatin, vasopressin, insulin, growth hormones, Substance P, ADF (ATL-derived factor, human thioredoxin), etc.; modified peptides as produced through modification of those peptides; animal-derived peptides such as bombesin; microorganism-derived peptides such as asparaginase; and plant-derived peptides such as lysine. In addition to these, antibodies are also within the scope of such physiologically-active peptides.
Antibodies of that type include not only human monoclonal antibodies but also animal monoclonal antibodies. Some of such antibodies have been being already used in medicines and diagnostic reagents, and some others are being studied for their use in medicines and diagnostic reagents.
For example, in the field of clinical medicine, IL-2 is used in carcinostatics; erythropoietin and G-CSF are in hematinics; and insulin and growth hormones are used for treating patients who are in congenital or acquired failure in or insufficiency for these. The use of IL-6 in platelet enhancers for use in clinical medicine is being under development.
As mentioned above, physiologically-active peptides are important as medicines; and various modifications of these peptides with polymer substances and the like are being made for the purpose of imparting new functions to the peptides and for the purpose of compensating for lack of safe usability of the peptides in medicine.
For example, a congenital immune disorder, adenosine deaminase insufficiency is caused by the insufficiency for normal adenosine deaminase (ADA), for which is used a medicine comprising polyethylene glycol (PEG)-modified ADA for the purpose of prolonging the in-vivo retention time for ADA.
On the other hand, for many of physiologically-active peptides, it is indispensable to specifically bond to the corresponding receptors or ligands in order to exhibit their physiological functions; and on the basis of the specific bonding of that type, it may be possible to utilize specific physiologically-active peptides as targeting molecules.
For example, a proposal has been made for bonding diphtherotoxin to IL-6 molecules and delivering the thus-bonded diphtherotoxin specifically to cancer cells having IL-6 receptors thereby to kill the cancer cells. Apart from this, a method has been developed for bonding a carcinostatic to a monoclonal antibody capable of recognizing a cancer-specific antigen, followed by delivering the thus-bonded carcinostatic specifically to cancer cells. It is said that the method will be also effective for killing cancer cells.
In addition, means of utilizing physiologically-active peptides in drug delivery systems (DDS) are important even in the field of genetic treatment. In particular, great expectations are put on the in-vivo administration of genes for genetic treatment. For example, George Y. Wu et al. have developed a method of genetic treatment in which a polylysine (this is charged positively) are chemically bonded to a physiologically-active peptide, such as orosomucoid, then a DNA plasmid (this is charged negatively) is enveloped in the resulting composite, and the thus-enveloped DNA is delivered to liver cells having orosomucoid receptors (see J. Biol. Chem., 263, 14621, 1988).
The problems on the use of physiologically-active peptides in clinical medicine are mentioned below.
It may be believed that, even when physiologically-active peptides, which physiologically act
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Motoki Masao
Takahara Yoshiyuki
Yamada Naoyuki
Ajinomoto Co. Inc.
Drug Delivery System Institute, Ltd.
Lukton David
Woodward Michael P.
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