"Development of new drugs in Japan" Development of new antibodies that attack corona Shimane University et al.
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In the future, we would like to use it for antibody drugs and test kits through demonstration experiments by humans.
Research groups such as Shimane University have succeeded in developing a new antibody that attacks the new coronavirus, a reporter on the XNUMXrd. → Continue reading
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Normal antibody (Polyclonal antibody) IsantigenでImmunology officialAnimal OfserumSince it is prepared from a mixture of various antibody molecular species, the monoclonal antibody has a uniform antibody molecular species.antigenIs multipleEpitopeStrictly speaking, since a polyclonal antibody is a mixture of antibodies against each epitope, it often contains (antigenic determinants), and thus strictly includes antibody molecules having different antigen specificities. In contrast, a monoclonal antibody has a single antigen epitope and therefore has a single antigen specificity.
Antibody production細胞とMyelomaFused cells that have the ability to grow autonomously by fusing cells with cellsHybridoma (hybridoma) is prepared, and only the fused cells having the desired antigen specificity are selected (screened) and used as the antigen cells. This antigen cellcultureThen, the secretion product is purified to produce the desired monoclonal antibody. Invented a method for producing monoclonal antibodies in 1975Georges JF KoehlerとSesar MilsteinWas in 1984Nobel Prize in Physiology or MedicineWas awarded.
Monoclonal antibodies invented in the 1970s were said to cause revolutionary changes in clinical practice, but for almost 20 years after that, clinical trials failed. This is mainlymouseAntibodyHuman capitalThe cause was that the antigen was recognized by the. However, in the 1990s, it expressed human immunoglobulin genes, not mice.PlasmidDirectlyTransformationThis problem has been overcome since the method was developed. This method has evolved further, and nowadays, without using hybridomas, a method in which the optimal antibody is screened from a huge clonal library consisting of 1 trillion molecules by phage display and the gene is mass-produced in CHO cells is used. ing. Or produce human antibodiesTransgenic mouseAnd a method for directly obtaining a human antibody is used. These methods are said to require a development cost of only about 2 million yen up to the preclinical stage, and are extremely efficient as compared with the conventional classical chemicals of 20 billion yen. However, because cell culture is required, the cost of manufacturing the final product is much higher than that of chemical synthesis chemicals.
Monoclonal antibodyproteinIt is a drug, and unlike so-called chemicals, it has the drawbacks that it cannot be administered orally (usually an injection once a week), the manufacturing cost is very high, and it cannot invade inside cells. However, once bound to the target molecule, the patient's own immune system activates and contains the target moleculecancer cellIt has the advantage that it can be destroyed at a high rate. Further, since immunoglobulin itself is a molecule existing in the human body, side effects due to itself are easy to predict.
In principle, polyclonal antibodies can also be used clinically, but in order to use them as drugs for human patients, the molecules within the drugs are chemically defined strictly, and they are highly purified and stable. It is said that it is almost impossible in reality because it needs to be mass produced. An immunoglobulin preparation derived from human plasma (blood preparation) is a kind of polyclonal antibody, and has been shown to be effective against various intractable diseases. However, the reason why these immunoglobulin preparations derived from blood cannot be easily replaced with recombinant antibody preparations is because of the above-mentioned difficulty in quality control.
Role in the US biotechnology industry
Monoclonal antibodies have been around since the late 1990sBiotechnologyRevolutionizing the industry, nearly one-third of today's biotechnology drugs are monoclonal antibodies. In 3, GENETECHRituxanAntibodyAnti-CD20 antibodyAsNon-Hodgkin lymphoma (NHL) has been approved,Herceptin, AvastinCurrently, more than 15 monoclonal antibodies are used for cancer treatment, including new types targeting signal transduction and angiogenesis, and at least more than 100 monoclonal antibodies have been developed in Phase I/II/III clinical trials. There is. Used in cancer therapy in particular, 2004 sales were about $60 billion and by 2008 monoclonal antibody sales are expected to exceed $150 billion. Also called next-generation monoclonal antibody,RadioisotopeNew types have been developed, such as those that are combined with or that are ultra-compact with only the antibody variable region.
Successful antibody sales are huge,TNF-αantibodyRemicade(Centocor) is the top blockbuster product with $21 billion and Rituxan with $17 billion. In particular, all three monoclonal antibody products developed by GENETECH (Rituxan, Herceptin, Avastin) are FDA-approved and all are hit products. This is a rare success in the history of the US pharmaceutical industry, given that typically 3% of the products survive a 4-6 year clinical trial.
One of the most successful factors for monoclonal antibodies is that they are molecules that originally evolved as bioprotective proteins, so they are extremely stable and have a long half-life compared to other proteins. Since it is used, the amplification effect can be expected. Compared with this, antisense drugs, which are also under development since the 1990s, are located in the nucleus of target cells.輸送Since doing so is a difficult task itself, almost all products for which GENTA and ISIS have invested enormous development costs have failed.
Pharmaceuticals marketed in Japan
The name of a monoclonal antibody drug is represented by the ending "-mab" (Monoclonal AntiBodies).
Some monoclonal antibodies, such as bevacizumab and cetuximab, can cause various types of side effects.  These side effects can be divided into general side effects and serious side effects. 
Common side effects include:
Dizziness Headache Allergy Diarrhea Cough Fever Itching Back pain General weakness Appetite loss Insomnia Constipation 
Possible serious side effects include:
Anaphylactic bleeding Arterial and venous thrombosis Autoimmune thyroiditis Hypothyroidism Hepatitis Heart failure Cancer Anemia Leukocyte depletion Stomatitis Enteritis Gastrointestinal perforation mucositis 
Rapid disease diagnosis kit
Various rapid diagnostic kits using monoclonal antibodies are on the market. Diagnosis can be made in 5 to 15 minutes. For example, for infectious diseasesInfluenza virus,RS virus,Adenovirus,Pneumonia mycoplasma,Norovirus,Rotavirus,Pneumococcus,Legionella,, and so on.