mbl companyprofile 2017-2018 en株式会社医学生物学研究所様会社概要 p01-02 1...

http: / /www.mbl.co. jp/

2017 - 2018

COMPANY PROFILE

KDX Nagoya Sakae Bldg. 10F, 4-5-3 Sakae, Naka-ku, Nagoya, Aichi 460-0008 Japan Phone: +81-52-238-1901, Facsimile: +81-52-238-1440 Issued: 2017.10

株式会社医学生物学研究所様　会社概要　P01-02

1 Medical & Biological Laboratories Co., LTD. Medical & Biological Laboratories Co., LTD. 2

The life sciences industry is providing new products and services ever more rapidly through diversification and advancements in science and multidisciplinary technologies. We have seen truly remarkable progress in recent years including highly efficacious molecular targeted drugs, immune checkpoint inhibitors, regenerative medicine products, personalized genetic testing services, big data analytics in the healthcare domain and more. Numerous innovative products have been created by the fusion of heterogeneous technologies and MBL strives to be at the forefront of that innovation.

MBL has long been engaged in laboratory testing which is at a profound turning point in product offerings. With an increased focus on early diagnosis, accurate monitoring of disease state and implementation of optimal therapies, the role and importance of laboratory testing has shifted to providing tools to determine “the most suitable treatment for the most suitable patients at the most suitable time” and “disease risk information to individuals before the onset of diseases”.

MBL began its history in 1969 as the first Japanese company specializing in the production and supply of antibodies. While maintaining close research and development relationships with academic institutes and pharmaceutical companies, MBL has broadened its basis of operations from immunology to molecular biology and epigenetics. We also provide clinical diagnostics and research reagents for protein and genetic analysis primarily for autoimmune diseases, cancers, gynecologic diseases and infectious diseases. In recent years, MBL has also focused its product development on biomarkers, companion diagnostics and regenerative medicine.

In the future, MBL plans to focus on developing cutting-edge diagnostic products, tools, and other services, more closely linked to patient therapies. We also aim to pursue corporate development initiatives that will lead us in unique directions, not only for, clinical areas but also for our research reagent business enterprises. In research reagents, our efforts will focus on our life science translational research (LSTR)* product groups, which are specifically related to molecular diagnosis as well as the elucidation of various diseases. MBL plans to develop the appropriate LSTR products into clinical diagnostic assays that would target our focus disease areas.

We understand that MBL’s clinical diagnostics play a critical role in helping practitioners to decide on treatment options for individual patients. We will further endeavor to improve our quality management systems for diagnostic products throughout all our processes from research and development to regulatory approval, manufacturing, marketing and sales through technical support.

As a consolidated subsidiary of JSR Corporation, MBL has integrated its life sciences business with JSR Corporation. We are now actively collaborating with JSR in research and development activities and expanding our global business operations in the United States, Europe and China. It is our desire to contribute to society as “a globally recognized niche company capable of creating value in the field of cutting-edge diagnostics” within the ever diversifying and profoundly changing life science industry. It is my sincere hope that you will grant us your continued support and guidance.

October 2017

President and CEOKimimasa Yamada

* See page 10 for information regarding LSTR business.

Message from the President

MBL’s Vision for the Future

Corporate Mission

We, MBL, are o�ering novel diagnostic reagents to meet healthcare needs of patients, no matter many or few.

A global niche company with a strong presence, we are creating values at the cutting-edge of diagnostics.

The life sciences industry is providing new products and services ever more rapidly through diversification and advancements in science and multidisciplinary technologies. We have seen truly remarkable progress in recent years including highly efficacious molecular targeted drugs, immune checkpoint inhibitors, regenerative medicine products, personalized genetic testing services, big data analytics in the healthcare domain and more. Numerous innovative products have been created by the fusion of heterogeneous technologies and MBL strives to be at the forefront of that innovation.

MBL has long been engaged in laboratory testing which is at a profound turning point in product offerings. With an increased focus on early diagnosis, accurate monitoring of disease state and implementation of optimal therapies, the role and importance of laboratory testing has shifted to providing tools to determine “the most suitable treatment for the most suitable patients at the most suitable time” and “disease risk information to individuals before the onset of diseases”.

MBL began its history in 1969 as the first Japanese company specializing in the production and supply of antibodies. While maintaining close research and development relationships with academic institutes and pharmaceutical companies, MBL has broadened its basis of operations from immunology to molecular biology and epigenetics. We also provide clinical diagnostics and research reagents for protein and genetic analysis primarily for autoimmune diseases, cancers, gynecologic diseases and infectious diseases. In recent years, MBL has also focused its product development on biomarkers, companion diagnostics and regenerative medicine.

In the future, MBL plans to focus on developing cutting-edge diagnostic products, tools, and other services, more closely linked to patient therapies. We also aim to pursue corporate development initiatives that will lead us in unique directions, not only for, clinical areas but also for our research reagent business enterprises. In research reagents, our efforts will focus on our life science translational research (LSTR)* product groups, which are specifically related to molecular diagnosis as well as the elucidation of various diseases. MBL plans to develop the appropriate LSTR products into clinical diagnostic assays that would target our focus disease areas.

We understand that MBL’s clinical diagnostics play a critical role in helping practitioners to decide on treatment options for individual patients. We will further endeavor to improve our quality management systems for diagnostic products throughout all our processes from research and development to regulatory approval, manufacturing, marketing and sales through technical support.

As a consolidated subsidiary of JSR Corporation, MBL has integrated its life sciences business with JSR Corporation. We are now actively collaborating with JSR in research and development activities and expanding our global business operations in the United States, Europe and China. It is our desire to contribute to society as “a globally recognized niche company capable of creating value in the field of cutting-edge diagnostics” within the ever diversifying and profoundly changing life science industry. It is my sincere hope that you will grant us your continued support and guidance.

October 2017

President and CEOKimimasa Yamada

* See page 10 for information regarding LSTR business.

Message from the President

MBL’s Vision for the Future

Corporate Mission

We, MBL, are o�ering novel diagnostic reagents to meet healthcare needs of patients, no matter many or few.

A global niche company with a strong presence, we are creating values at the cutting-edge of diagnostics.

Technologies for recombinant antigen-protein expression and purification are extremely important for growth and innovation in MBL’s core business of autoantibody*2 measurement reagents. MBL scrutinizes properties of antigen proteins obtained from expression systems such as E. coli, insect cells, and mammalian cells and selects optimal antigen proteins in terms of biological performance, factory productivity, and economic efficiency. In order to produce and supply high-quality and high-purity reagents, selected proteins are purified by making the best use of all available methods, including an affinity purification method using MBL’s own antibodies for tag sequences and liquid chromatography purification.

Protein Production Technologies

MBL has had solid antibody development and production technologies as its core competencies since the beginning of the company. In addition to these technologies, MBL fully utilizes genetic engineering and protein expression/puri�cation technologies in the development of products, such as in vitro diagnostics and research reagents.

*1. Recombinant: Genetic engineering*2. Autoantibody: An antibody reacting with antigenic constituents of the host’s tissue (or “self-antigen”) in autoimmune and other certain diseases

Fluoppi: The technology that MBL developed for visualization of protein-protein interactions (PPI) in living cells.

MBL has introduced and established systems for generating recombinant*1 antibodies by directly extracting antibody genes from one antibody-producing B lymphocyte, as a technological approach to acquire higher-quality antigen-specific antibodies, in addition to conventional antibody production technologies. MBL’s new technology is theoretically capable of yielding target antibody-generating genes with an extremely high probability, and thereby promises to be dozens of times more efficient than conventional methods of producing monoclonal antibodies using hybridoma technologies. Efficient capture of a wide variety of specific antibodies is extremely advantageous in selecting antibodies best suited for various measurement systems.

Antibody Acquisition Technologies

Utilizing its own antibody and protein engineering technologies, MBL is developing more unique in vitro diagnostics and various measurement systems that will yield novel in vitro diagnostics in the future. In 2010, MBL added and launched a new business line of chemiluminescent immunoassays (CLEIA) to the company’s conventional business with ELISA method. CLEIA provides you fully automated measurement of autoantibodies and a drastic time reduction in measurement time, and have now become the company’s flagship business. Further, the company has invested a substantial amount of resources into the development of latex agglutination reagents to offer a more versatile measurement system, and has achieved detection sensitivity to rival that of the ELISA method, depending on assay parameters.

Immunological Assay Kits and Reagents

Various types of research reagents are used in life sciences including medicine. MBL is also engaged in the development of laboratory products in this area, utilizing the company’s afore-mentioned core technologies. Our product lines are diverse, as demonstrated by our research areas of various specific antibodies, novel biomarkers for the ELISA measurement system, enzyme activity measurement systems for drug screening, immune function diagnostic reagents (major histocompatibility complex [MHC] tetramers), protein fluorescent labeling reagents, etc. In these research and development activities, we are also pursuing potential future clinical diagnostics.

MBL has developed a large number of reagents to support laboratory works from the extraction to detection of nucleic acids. In particular, our company has produced a number of in vitro diagnostics based on a PCR-reverse sequence-specific oligonucleotide probe (PCR-rSSO) method with Luminex® (xMAP®) technology, which is capable of simultaneously analysis of multiple types of genes. Recently, the company has introduced state-of-the art technologies for genetic assays, such as the real-time PCR method, next-generation DNA sequencers, and digital PCR technology, and is developing reagents capable of capturing gene information promptly and with high sensitivity to aid the diagnosis of cancers, infections, and other medical conditions. These reagents can help medical professionals to obtain information useful in designing personalized treatment, such as optimal therapeutic approach and choice of drugs.

Genetic Assay Technology

MBL began researching and implementing antibody production, purification, and processing technologies by using polyclonal antibodies derived from animal sera, followed by the era of technologies using mouse monoclonal antibodies. The company’s technology has now shifted to the current new generation of recombinant antibodies. Recombinant antibody technologies are powerfully effective in realizing drastic productivity improvement and cost cutting. The mass production of low-cost, high-quality antibodies will substantially increase the competitiveness of finished products on the market.

Antibody Production Technologies

CoreTechnologies

Clinical Diagnostics Development

Research Reagents

Antigen-bound magnetic particle

Enzyme-labeled antibody

Fluorescent imaging agent

Antibodies in a sample

Technologies for recombinant antigen-protein expression and purification are extremely important for growth and innovation in MBL’s core business of autoantibody*2 measurement reagents. MBL scrutinizes properties of antigen proteins obtained from expression systems such as E. coli, insect cells, and mammalian cells and selects optimal antigen proteins in terms of biological performance, factory productivity, and economic efficiency. In order to produce and supply high-quality and high-purity reagents, selected proteins are purified by making the best use of all available methods, including an affinity purification method using MBL’s own antibodies for tag sequences and liquid chromatography purification.

Protein Production Technologies

MBL has had solid antibody development and production technologies as its core competencies since the beginning of the company. In addition to these technologies, MBL fully utilizes genetic engineering and protein expression/puri�cation technologies in the development of products, such as in vitro diagnostics and research reagents.

*1. Recombinant: Genetic engineering*2. Autoantibody: An antibody reacting with antigenic constituents of the host’s tissue (or “self-antigen”) in autoimmune and other certain diseases

Fluoppi: The technology that MBL developed for visualization of protein-protein interactions (PPI) in living cells.

MBL has introduced and established systems for generating recombinant*1 antibodies by directly extracting antibody genes from one antibody-producing B lymphocyte, as a technological approach to acquire higher-quality antigen-specific antibodies, in addition to conventional antibody production technologies. MBL’s new technology is theoretically capable of yielding target antibody-generating genes with an extremely high probability, and thereby promises to be dozens of times more efficient than conventional methods of producing monoclonal antibodies using hybridoma technologies. Efficient capture of a wide variety of specific antibodies is extremely advantageous in selecting antibodies best suited for various measurement systems.

Antibody Acquisition Technologies

Utilizing its own antibody and protein engineering technologies, MBL is developing more unique in vitro diagnostics and various measurement systems that will yield novel in vitro diagnostics in the future. In 2010, MBL added and launched a new business line of chemiluminescent immunoassays (CLEIA) to the company’s conventional business with ELISA method. CLEIA provides you fully automated measurement of autoantibodies and a drastic time reduction in measurement time, and have now become the company’s flagship business. Further, the company has invested a substantial amount of resources into the development of latex agglutination reagents to offer a more versatile measurement system, and has achieved detection sensitivity to rival that of the ELISA method, depending on assay parameters.

Immunological Assay Kits and Reagents

Various types of research reagents are used in life sciences including medicine. MBL is also engaged in the development of laboratory products in this area, utilizing the company’s afore-mentioned core technologies. Our product lines are diverse, as demonstrated by our research areas of various specific antibodies, novel biomarkers for the ELISA measurement system, enzyme activity measurement systems for drug screening, immune function diagnostic reagents (major histocompatibility complex [MHC] tetramers), protein fluorescent labeling reagents, etc. In these research and development activities, we are also pursuing potential future clinical diagnostics.

MBL has developed a large number of reagents to support laboratory works from the extraction to detection of nucleic acids. In particular, our company has produced a number of in vitro diagnostics based on a PCR-reverse sequence-specific oligonucleotide probe (PCR-rSSO) method with Luminex® (xMAP®) technology, which is capable of simultaneously analysis of multiple types of genes. Recently, the company has introduced state-of-the art technologies for genetic assays, such as the real-time PCR method, next-generation DNA sequencers, and digital PCR technology, and is developing reagents capable of capturing gene information promptly and with high sensitivity to aid the diagnosis of cancers, infections, and other medical conditions. These reagents can help medical professionals to obtain information useful in designing personalized treatment, such as optimal therapeutic approach and choice of drugs.

Genetic Assay Technology

MBL began researching and implementing antibody production, purification, and processing technologies by using polyclonal antibodies derived from animal sera, followed by the era of technologies using mouse monoclonal antibodies. The company’s technology has now shifted to the current new generation of recombinant antibodies. Recombinant antibody technologies are powerfully effective in realizing drastic productivity improvement and cost cutting. The mass production of low-cost, high-quality antibodies will substantially increase the competitiveness of finished products on the market.

Antibody Production Technologies

CoreTechnologies

Clinical Diagnostics Development

Research Reagents

Antigen-bound magnetic particle

Enzyme-labeled antibody

Fluorescent imaging agent

Antibodies in a sample

MBL is working in collaboration with the academia and pharmaceutical companies to develop disease-related research reagents (LSTR* products) with the aim of sowing the seeds for future clinical diagnostics.

MBL holds top place in terms of the number of in vitro diagnostic products newly registered in the national reimbursement price list in Japan. Our company has been actively engaged in the development of diagnostics for not only prevalent diseases but also orphan and intractable diseases. MBL is also actively researching and developing products based on new measurement systems and is contributing to efficient and automated assay of biological specimens at clinical laboratories. Further, MBL is developing products for personalized medicine customized to the medical needs of individual patients, such as gene-detection reagent kits for the diagnosis of cancer and infections and companion diagnostics for the pre-medication evaluation of potential patient response. Universities

Hospitals

Clinical laboratories

Segments of Business

* LSTR is a business category in which we conduct research and development of research reagents with an aim to create clinical diagnostics based on them.

Lines of Business

Clinical (In Vitro) Diagnostic Products Business

Life Science Translational Research (LSTR) Business

Public research institutes

Pharmaceuticalcompanies

Commercialization of products

and technologies

Manufacturing and sales

Regulatory approval

and technologies

Market research and survey

Research and development

Clinical development

Clinical Diagnostics and In Vitro DiagnosticsThe clinical diagnostics for diseases are regarded as medicines in Japan and are classified into in vivo and in vitro diagnostics. In vitro diagnostics are not directly applied to the human body, but are instead used to detect and measure certain substances present in biological samples from humans, such as blood and urine, at hospitals and clinical laboratories.

Source: Partially modified from the website of Japan Association of Clinical Reagents Industries

Therapeutic medicines

Medicines

In vivo diagnostics

Medical diagnostics

Reagents

In vitro diagnostics Clinicaldiagnostics

(Classi�cation of clinical diagnostics)

MBL is working in collaboration with the academia and pharmaceutical companies to develop disease-related research reagents (LSTR* products) with the aim of sowing the seeds for future clinical diagnostics.

MBL holds top place in terms of the number of in vitro diagnostic products newly registered in the national reimbursement price list in Japan. Our company has been actively engaged in the development of diagnostics for not only prevalent diseases but also orphan and intractable diseases. MBL is also actively researching and developing products based on new measurement systems and is contributing to efficient and automated assay of biological specimens at clinical laboratories. Further, MBL is developing products for personalized medicine customized to the medical needs of individual patients, such as gene-detection reagent kits for the diagnosis of cancer and infections and companion diagnostics for the pre-medication evaluation of potential patient response. Universities

Hospitals

Clinical laboratories

Segments of Business

* LSTR is a business category in which we conduct research and development of research reagents with an aim to create clinical diagnostics based on them.

Lines of Business

Clinical (In Vitro) Diagnostic Products Business

Public research institutes

Pharmaceuticalcompanies

and technologies

Manufacturing and sales

Regulatory approval

and technologies

Market research and survey

Research and development

Clinical development

Clinical Diagnostics and In Vitro DiagnosticsThe clinical diagnostics for diseases are regarded as medicines in Japan and are classified into in vivo and in vitro diagnostics. In vitro diagnostics are not directly applied to the human body, but are instead used to detect and measure certain substances present in biological samples from humans, such as blood and urine, at hospitals and clinical laboratories.

Source: Partially modified from the website of Japan Association of Clinical Reagents Industries

Therapeutic medicines

Medicines

In vivo diagnostics

Medical diagnostics

Reagents

In vitro diagnostics Clinicaldiagnostics

(Classi�cation of clinical diagnostics)

MBL has been leading the clinical diagnostics market for over 30 years.

Autoimmune Disease Area

MBL provides genetic test products that assist the selection of optimal treatment regimens for cancer and other diseases.

Genetic Testing

Lines of Business

An autoimmune disease is a state in which a disorder of the immune mechanism causes it to mistakenly identify and attack body’s own tissues and cells as foreign objects. Autoimmune diseases are broadly categorized into systemic autoimmune diseases and organ-specific autoimmune diseases. Many autoimmune diseases are designated as intractable diseases by Japan’s Ministry of Health, Labour and Welfare (MHLW). Diagnosis of autoimmune diseases requires accurate measurement of parameters and indicators which are specific to individual immune disorders. Laboratory test results also serve to not only diagnose patient condition but also predict subsequent disease progression and determine a course of treatment. MBL provides diagnostic reagents covering a broad range of autoimmune diseases and provides support for a variety of laboratory procedures from basic health screening to follow-up tests.MBL is at the top of the clinical diagnostics segment in terms of the “number of parameters for assay with diagnostic reagents” newly registered in the national reimbursement price list during the period from February 2003 to December 2016. Thus, MBL has been leading the clinical diagnostics market for over 30 years since the establishment of its own research and development, production, and marketing system in 1983.

In recent years, personalized medicine has become recognized as particularly important in selecting and designing optimal treatment regimens for individual patient. Personalized medicine is treatment optimally tailored to individual patient’s needs based on not only routine clinical information but also genomic background and physiological status as determined by disease-related biomarkers. Biomarkers are the subset of markers that serve as indicators of patient response to treatment, such as change in disease status, treatment effect, and adverse reactions, by measuring biological substances including proteins and genes. In molecular targeted therapy*, potentially responsive patients are identified based on the measurement of various biomarkers prior to treatment initiation and then the expected efficacy is determined. Thus, the tailoring contributes to the maximization of efficacy and minimization of adverse reactions. In particular, biomarkers for tailoring are required to be capable of not only identifying a specific mutation but also providing information on multiple gene mutations. MBL reagents meet these requirements with their simple, convenient, and cost-effective genetic diagnostic systems.

* Molecular targeted therapy: A therapeutic approach to target key molecules of cancer cells and inhibit the biological function of those molecules.

Chronic thyroiditis (CT) (Hashimoto thyroiditis)

Basedow’s disease (BD)

Organ-Speci�c Autoimmune Diseases

Autoimmune hepatitis (AIH) Primary biliary cirrhosis (PBC)

Myasthenia gravis (MG) and multiple sclerosis (MS)

Ulcerative colitis (UC) Crohn’s disease (CD)

Autoimmune pancreatitis (AIP)

Pemphigus Pemphigoid (including

epidermolysis bullosa aquisita [EBA])

Goodpasture’s syndrome (GPS) Crescentic glomerulonephritis

Clinical Diagnostics Business

Baseline screening

De�nitive diagnostic

�erapeutic decision-making

Patient treatment

Follow-up tests

SystemicSymptoms

FeverMalaise

Weight loss Pain,

swelling, etc. in the joints

Muscle pain and weakness

Skin symptoms Organ damage

Rheumatoid arthritis (RA)

Systemic lupus erythematosus (SLE)

Antiphospholipid syndrome (APS)

Systemic sclerosis, scleroderma (SSc)

Polymyositis/dermatomyositis (PM/DM)

Mixed connective tissue disease (MCTD)

Sjögren’s syndrome (SS)

Polyarteritis nodosa (PAN)

Microscopic polyangiitis (MPA)

Granulomatosis with polyangitis (GPA) (Wegener’s granulomatosis [WG])

Eosinophilic granulomastosis with polyangiitis (EGPA) (Allergic granulomatous angitis: [AGA] and Churg-Strauss syndrome [CSS])

Systemic Autoimmune Diseases

Thyroid

Nerve and muscle

Pancreas

Kidney

Gastrointestinaltract

MBL has been leading the clinical diagnostics market for over 30 years.

Autoimmune Disease Area

MBL provides genetic test products that assist the selection of optimal treatment regimens for cancer and other diseases.

Genetic Testing

Lines of Business

An autoimmune disease is a state in which a disorder of the immune mechanism causes it to mistakenly identify and attack body’s own tissues and cells as foreign objects. Autoimmune diseases are broadly categorized into systemic autoimmune diseases and organ-specific autoimmune diseases. Many autoimmune diseases are designated as intractable diseases by Japan’s Ministry of Health, Labour and Welfare (MHLW). Diagnosis of autoimmune diseases requires accurate measurement of parameters and indicators which are specific to individual immune disorders. Laboratory test results also serve to not only diagnose patient condition but also predict subsequent disease progression and determine a course of treatment. MBL provides diagnostic reagents covering a broad range of autoimmune diseases and provides support for a variety of laboratory procedures from basic health screening to follow-up tests.MBL is at the top of the clinical diagnostics segment in terms of the “number of parameters for assay with diagnostic reagents” newly registered in the national reimbursement price list during the period from February 2003 to December 2016. Thus, MBL has been leading the clinical diagnostics market for over 30 years since the establishment of its own research and development, production, and marketing system in 1983.

In recent years, personalized medicine has become recognized as particularly important in selecting and designing optimal treatment regimens for individual patient. Personalized medicine is treatment optimally tailored to individual patient’s needs based on not only routine clinical information but also genomic background and physiological status as determined by disease-related biomarkers. Biomarkers are the subset of markers that serve as indicators of patient response to treatment, such as change in disease status, treatment effect, and adverse reactions, by measuring biological substances including proteins and genes. In molecular targeted therapy*, potentially responsive patients are identified based on the measurement of various biomarkers prior to treatment initiation and then the expected efficacy is determined. Thus, the tailoring contributes to the maximization of efficacy and minimization of adverse reactions. In particular, biomarkers for tailoring are required to be capable of not only identifying a specific mutation but also providing information on multiple gene mutations. MBL reagents meet these requirements with their simple, convenient, and cost-effective genetic diagnostic systems.

* Molecular targeted therapy: A therapeutic approach to target key molecules of cancer cells and inhibit the biological function of those molecules.

Chronic thyroiditis (CT) (Hashimoto thyroiditis)

Basedow’s disease (BD)

Organ-Speci�c Autoimmune Diseases

Autoimmune hepatitis (AIH) Primary biliary cirrhosis (PBC)

Myasthenia gravis (MG) and multiple sclerosis (MS)

Ulcerative colitis (UC) Crohn’s disease (CD)

Autoimmune pancreatitis (AIP)

Pemphigus Pemphigoid (including

epidermolysis bullosa aquisita [EBA])

Goodpasture’s syndrome (GPS) Crescentic glomerulonephritis

Clinical Diagnostics Business

Baseline screening

De�nitive diagnostic

�erapeutic decision-making

Patient treatment

Follow-up tests

SystemicSymptoms

FeverMalaise

Weight loss Pain,

swelling, etc. in the joints

Muscle pain and weakness

Skin symptoms Organ damage

Rheumatoid arthritis (RA)

Systemic lupus erythematosus (SLE)

Antiphospholipid syndrome (APS)

Systemic sclerosis, scleroderma (SSc)

Polymyositis/dermatomyositis (PM/DM)

Mixed connective tissue disease (MCTD)

Sjögren’s syndrome (SS)

Polyarteritis nodosa (PAN)

Microscopic polyangiitis (MPA)

Granulomatosis with polyangitis (GPA) (Wegener’s granulomatosis [WG])

Eosinophilic granulomastosis with polyangiitis (EGPA) (Allergic granulomatous angitis: [AGA] and Churg-Strauss syndrome [CSS])

Systemic Autoimmune Diseases

Thyroid

Nerve and muscle

Pancreas

Kidney

Gastrointestinaltract

Research Reagents Directed toward the Development and Commercialization of Clinical DiagnosticsTumor Marker Testing

MHC Tetramers

Pathological Tissue Examination

Cytological Testing

Lines of Business

Tumor markers are proteins and genes that are specifically produced by tumor cells and released into the circulation and can thus be measured in the blood and urine in certain amounts as signs of tumors. MBL supports accurate diagnosis of cancers with its diagnostic reagents of tumor markers and those of autoantibodies to tumor markers. MBL is researching and developing antibodies and assay kits by

utilizing its core technologies of antibody production and supporting the academia and pharmaceutical industry in their research activities. Our company’s high-quality antibody and kit products have long been highly esteemed among researchers in molecular (cellular) biology and are broadly supporting their basic laboratory to clinical research activities.

MBL has extensive lineups of products and technologies using unique fluorescent proteins. These are essential technologies and tools for the discovery of molecular target drugs at an early phase of new drug discovery and hence are widely used in research and development by pharmaceutical companies and research institutes worldwide.

MBL is the only company in Japan developing and marketing “major histocompatibility complex (MHC) tetramers” used to detect antigen-specific T cells that play an important role in immune-cell therapy for cancer, etc. MBL is also undertaking collaborative research with academic institutes and is contributing to their activities with its technologies and know-how on cancer treatment.

MBL contributes to the progress in pathology and pathological examination with its extensive product lines (research reagents), including immunohistochemical staining antibodies, various detection kits, and in situ hybridization reagents.

Cytological testing is a test to collect cells from the target area of the body and pathologically determine malignancy or benignancy of the cells under microscopy. The test is particularly useful for the diagnosis of uterine cancer. MBL provides and pursues higher accuracy of cytological testing through standardization and supply of a liquid-based cytological testing system, “TACAS™,” which can also be used for other types of test (e.g. genetic tests and immunocytochemistry staining assays).NB: Available only in Japan.

MBL supports the academia and industry with various technologies and know-how on antibody production, modification, and labeling.

Antibodies Fluorescent Proteins

Normal cells

Antibody to tumor marker

Tumor marker

Cancer cells

Antigen-specific T cellT-cell receptors

Fluorescence-labeled substance

MHC molecule

Peptide

Research Reagents Directed toward the Development and Commercialization of Clinical DiagnosticsTumor Marker Testing

MHC Tetramers

Pathological Tissue Examination

Cytological Testing

Lines of Business

Tumor markers are proteins and genes that are specifically produced by tumor cells and released into the circulation and can thus be measured in the blood and urine in certain amounts as signs of tumors. MBL supports accurate diagnosis of cancers with its diagnostic reagents of tumor markers and those of autoantibodies to tumor markers. MBL is researching and developing antibodies and assay kits by

utilizing its core technologies of antibody production and supporting the academia and pharmaceutical industry in their research activities. Our company’s high-quality antibody and kit products have long been highly esteemed among researchers in molecular (cellular) biology and are broadly supporting their basic laboratory to clinical research activities.

MBL has extensive lineups of products and technologies using unique fluorescent proteins. These are essential technologies and tools for the discovery of molecular target drugs at an early phase of new drug discovery and hence are widely used in research and development by pharmaceutical companies and research institutes worldwide.

MBL is the only company in Japan developing and marketing “major histocompatibility complex (MHC) tetramers” used to detect antigen-specific T cells that play an important role in immune-cell therapy for cancer, etc. MBL is also undertaking collaborative research with academic institutes and is contributing to their activities with its technologies and know-how on cancer treatment.

MBL contributes to the progress in pathology and pathological examination with its extensive product lines (research reagents), including immunohistochemical staining antibodies, various detection kits, and in situ hybridization reagents.

Cytological testing is a test to collect cells from the target area of the body and pathologically determine malignancy or benignancy of the cells under microscopy. The test is particularly useful for the diagnosis of uterine cancer. MBL provides and pursues higher accuracy of cytological testing through standardization and supply of a liquid-based cytological testing system, “TACAS™,” which can also be used for other types of test (e.g. genetic tests and immunocytochemistry staining assays).NB: Available only in Japan.

MBL supports the academia and industry with various technologies and know-how on antibody production, modification, and labeling.

Antibodies Fluorescent Proteins

Normal cells

Antibody to tumor marker

Tumor marker

Cancer cells

Antigen-specific T cellT-cell receptors

Fluorescence-labeled substance

MHC molecule

Peptide

Research and Production Bases

MBL has a research laboratory in Ina, Nagano Prefecture. Ina Laboratory undertakes the development and production of in vitro diagnostics and research reagents to be commercially distributed in Japan and overseas. The laboratory has expanded to meet growing demands for MBL products and a new facility, the “manufacturing facility No.2” (3 stories with a total floor area of 3,880 m2), was completed on October 31, 2015. The new facility has manufacturing equipment and sophisticated systems that can comply with inspection by overseas pharmaceutical regulatory agencies (e.g. the US FDA).

In addition, the new company established MBL Hangzhou Biotech Co., Ltd. (MBLH) in Yuhang, Hangzhou, Zhejiang in February 2017 to expand diagnostic raw material business in the fast-growing Chinese diagnostics market. The mission of MBLH is to promptly introduce new products that meet needs in the Chinese market and to reduce production costs of those products. MBLH is commencing its operations with the development of antibodies and development and production of latex diagnostic raw materials and the supply of high-quality products to customers in China. At the same time, the company has plans to develop original MBL branddiagnostics products and supply them to the Chinese market in the future.

Ina Laboratory

✓ Sales of MBL products✓ Sales of in vitro diagnostics raw materials manufactured by MBL and MBLH✓ Sales of JSR latex particles, magnetic particles, etc.

✓ Production base in China✓ Development and production of raw materials for in vitro diagnostic✓ Development and production of antibodies

✓ Development, production, and supply of in vitro diagnostics ✓ New technology development✓ Collaboration with MBLB and MBLH

Ina, Nagano

Manufacturing Facility No.2

HANGZHOU BIOTECH

1969 1975 1977 1987 1993 1996 2005 2015 2017Corporate history

History of MBL

1969 Foundation of MBL as the first antibody manufacturer/supplier in Japan

1975 Entry into clinical diagnostics field

1977 Start of research & development on diagnostics for autoimmune diseases

1987 Entry into research reagents field

1993 Establishment of a subsidiary company, MBL International Corporation, in Boston, USA

1996 Initial public offering on the JASDAQ Securities Exchange

2005 Establishment of a joint venture company, Beijing B&M Biotech Co., Ltd., (as of now MBL Beijing Biotech Co., Ltd) in China

2015 Affiliation with the JSR Corporation Group

2017 Establishment of MBL Hangzhou Biotech Co., Ltd. in the People’s Republic of China (Hangzhou).

History of Research and Product Development

1975 Succeeded in the production of “MBL Plate,” an immunodiffusion assay system of plasma proteins, developed first in Japan.1978 Launched “EIA IgE Test,” the world’s first allergy diagnostic reagent based on the enzyme immunoassay (EIA) method. 1984 Launched 3 products of the microplate-based “EIA MESACUP™” series. 1985 Launched “FLUORO HEPANA Test,” an antinuclear antibody diagnostic reagent based on the immunofluorescence method. 1991 Launched 4 products of the “MESACUP™ ” series, autoantibodies diagnostic reagent based on the ELISA with

genetically-engineered protein antigens. 1992 Launched “Anti-Fas (Human) Monoclonal Antibody,” a research reagent for use in the research of programmed cell death. 1998 Launched human and murine “IL-18 ELISA Kits” under the exclusive worldwide license for IL-18 granted by Hayashibara Biochemical

Labs. Inc. 2002 Set up a strategic alliance with Beckman Coulter, Inc., USA: the start of development, production, and sales of T-cell analysis

reagents based on the MHC tetramer technology as well as the start of contract research and collaborative research in association with this T-cell analysis area.

2007 Launched “MESACUP™ Anti-p53 Test,” a new reagent for measuring tumor markers for detecting autoantibodies. 2008 Launched “Fucci,” a set of probes for real-time monitoring of cell cycle progression by fluorescence imaging. 2009 Launched the “TACAS™” a set for cervical cancer test (slide, fixative solution, and instrument) using liquid-based cytological

samples, developed first in Japan. 2010 Launched “MESACUP™ Anti-RNA Polymerase III Test,” a diagnostic aid for screening systemic sclerosis. Launched “MESACUP™-2 Test CCP,” a clinical diagnostic for screening rheumatoid arthritis. Launched “MEBLux™ CL-CCP Test,” a series of fully-automated rapid test reagents for detecting autoantibodies by the

chemiluminescent immunoassay (CLEIA) method, developed first in Japan. Launched “MEBChrom™ CCP Test,” a series of test kits for detecting antibodies against citrullinated antigens based on the

immunochromatographic method. 2011 Launched 3 products of the “STACIA MEBLux™ Test” series, fully-automated rapid test reagents for detecting autoantibodies by the

CLEIA method. “FREELITE,” a series of diagnostic reagents for screening multiple myeloma and other disorders, was registered in the national

reimbursement price list. 2012 Launched 6 products of the “STACIA MEBLux™ Test” series, fully-automated rapid test reagents for screening systemic lupus

erythematosus (SLE) and other autoimmune diseases. Agreed on the transfer of business with Beckman Coulter, Inc., USA: the start of development, production, and sales of MHC tetramer

reagents and antigenic epitope reagents for screening infectious diseases and cancers worldwide. 2013 Launched “MEBGEN™ HPV Kit,” a reagent for detecting and typing high-risk human gynecological papillomavirus (HPV) genes. Launched 8 products of the “STACIA MEBLux™ Test” series, fully-automated rapid test reagents for screening a variety of

pemphigus and other autoimmune disorders. Launched “Fluoppi,” a technology for new drug discovery based on the visualization of protein-protein interactions (PPI) by

fluorescent imaging.2014 Launched “MESACUP™ Anti-ARS Test,” a diagnostic aid for screening polymyositis and dermatomyositis. Launched “STACIA MEBLux™ Test ANA,” a fully-automated rapid test reagent for detecting antinuclear antibodies. 2015 Launched “MEBGEN™ RASKET Kit,” a reagent useful in premedication testing of anti-EGFR antibody drugs in the treatment of

colorectal cancer. Launched “STACIA MEBLux™ Test BCA225,” a reagent for measuring a biomarker of breast cancer. 2016 Three products of diagnostic aid and in vitro diagnostics for screening polymyositis and dermatomyositis were registered in the

national reimbursement price list. Launched “FLUORO HEp-2 ANA test,” a reagent to be mounted on fully automatic HELIOS® immunofluorescence analyzer.

MBL Plate

MESACUP™ series

STACIA MEBLux™ series

TACAS™

MEBGEN™ series

FLUORO HEPANA Test

STACIA is a trademark of LSI Medience Corpration, registered in JP and other countries.