COMPANY PROFILET O PM E S S A G E

Our company was founded as Japanʼs ﬁrst antibody manufacturing company in 1969 to continuously take on
the innovative diagnostic technology for each life. We take great pride in consistently making straightforward
str i d es w i th the be l ie f t h a t it is wo rt h a c c eptin g th e c h al l en g e o f ﬁn d in g so l utio n s fo r suc h d iseas es t ha tno c o m p any has e v e r c o n f ro n t e d .
I n 1 9 7 0 s , w e i n i t i a t e d t h e d e v e l o p m e n t o f in vitro d i a g n o s t i c s f o r a u t o i m m u n e d i s e a s e s a s a l e a d e r o f
th e co m p ani es o f s u c h p ro d u c t s in J a p a n . Fur th er mo r e, we l aun c h ed th e d istr ibutio n o f a c ompa ni on
di agno s ti c ( CDx ) f o r t h e ﬁ rs t t im e in J a p a n, fo l l o wed by busin ess ev o l utio n th at in c l ud ed th e d ev elopmentof geneti c d i agn o st ic s e rv ic e s. In J a n u a ry 2021, o ur c o mpan y bec ame a wh o l l y o wn ed subsid iary of JS R
Co r p o r ati o n. B y f u rt h e r e n h a n c in g c o o p e ratio n with th e g r o up c o mpan ies o f J SR L ife Sc ien c es, we wi ll

We contribute ourinnovative diagnostic technology
to people's healthand medical development
CEO

Hiroki Itoprovi d e i nno vati ve d ru g d isc o v e ry su p p o rt s e r v ic es in th e ph ar mac eutic al an d bio tec h n o l o g y in d ustri es .
Becau s e fu tu r e eco n o m ic c o n d it io n s a n d b u sin ess en v ir o n men t ar e un c er tain , we ar e wil l in g to tr ans form
ourselves for future changes to create the future as intended with backcasting considerations. In particular,
the coronavirus disease (COVID-19) that aﬀected the world provided us with the opportunity to reconsider
our companyʼs signiﬁcance of existence. We will continuously strive to supply our diagnostic reagents inconsideration o f o ur c o m p a n yʼs p u rp o s e f o r t he h eal th an d h appin ess o f in d iv id ual s l iv in g ev er y d ay a nd a
se cur e s o c i ety ﬁ l l e d wit h l a u g h t e r.
We w i l l c o ntr i b u te t o p e o p l eʼs h e a l t h a n d m e d ic al d ev el o pm en t usin g o ur in n o v ativ e d iag n o stic tec h nology
to me et c o ns i s tent c h a l l e n g e s .

Our Businesses

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We supply high-quality clinical diagnostics to the medical industry.

We are also working vigorously to develop clinical diagnostics for rare and intractablediseases that are diﬃcult to diagnose, to ensure that patients with these diseases
are diagnosed promptly and so can start treatment as soon as possible.

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Our Businesses

02

In our eﬀorts to promote the spread of personalized medical care,

we are developing biomarkers and companion diagnostics (CDx) that provide
information for therapeutic approaches or decisions on medication.
We are also concentrating on our drug discovery support services,which contribute to the development of pharmaceuticals.

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Our Businesses

03

We provide global support for basic research through our high-performance

antibodies and kits of various types, with a focus on drug discovery in the ﬁeldsof cancer immunotherapy and regenerative medicine.

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Business Details

We carry out the whole process of R&D, raw material production and reagent
manufacturing, clinical performance study, regulatory applications, manufacturing,and marketing in-house. This has allowed us to build relationships of trust withresearchers and key opinion leaders (KOLs), enabling speedy commercializationof products. We not only market reagents following commercialization
but also market raw materials and play a role as an OEM supplier.

Raw materials /Reagents
M a n u f a c t u re o f p ro t e ins
f o r a s s a y s y s t e m d e v e l o p m e nt
a n d J S R a s s a y b e ad s

R&D
Assay syst e ms
( FCM / multipl ex a ssa ys /hi gh - sensi t i v ity a ssa ys)

ClinicalDevelopment
KOL n e t w o rk /P ro t o c o l p re p a ra t i o n /Regulatory
Approval

N e g o t i a t i o n s w i t h a u t ho ri t i es

Subst ant i al n u mb er ofappli c at i on a ppr ov a l s in J a pa nCommercialization
QMS compliance /H i g h- m i x , l o w - v o lu m e m a n u f a c t u ri ng

Manufacturing /Sales
E x t ensi ve do me stic a n df or ei gn sales syste ms /Smoot h and spe ed y d ome stic
di st ri but i on system

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Abundant of Experience and Expertise Amassed
Since the Birth of the Company
MBL was founded as Japanʼs ﬁrst antibody manufacturer, and antibody manufacturing technology has remained
a core technology and source of value creation for us. We assembled an elite team that brings together all thetechnology, expertise, and human resources we have accumulated since MBL was founded to create theantibodies needed for all our businesses. As well as components for basic research reagents and clinicaldiagnostics, we also create our own antibodies for use in in-house manufacturing and product quality testing,and thus are also making indirect contributions to our businesses from various diﬀerent angles.

Numerous Antibodies Acquired
Products developed

4,000Over 10,000

Over

Number of contract services(results over 18 years)

Wide-Ranging Antibody Development Technology
and Ability to Respond to Diverse Needs
Animal species formonoclonal antibodies

8

Number of antibody-related
proprietary licenses

Over

20

Results Derived from Therapeutic Antibody Seeds
Number of proprietarypatents out-licensed

6

Number of target molecules fordevelopment and implementation

Over

200

External Certiﬁcation Obtainedfor Animal Experiment Facilities
We have received accreditation from the Center for Accreditation of Laboratory Animal Care and Use, which isunder the umbrella of Japan Pharmaceutical Information Center, that animal experimentation at our facilities
is implemented correctly in accordance with the Basic Policy on Animal Experimentation Performed at theInstitutions under the Jurisdiction of the Ministry of Health, Labour and Welfare.

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From the perspective of patients and healthcare professionals, we will develop clinical diagnostics
that meet speciﬁc medical needs in cooperation with KOLs.

Clinical Diagnostics
Immunology / Serology Test Reagents:
Autoimmune Test Reagents
Working in collaboration with Japanese KOLs in the ﬁeld ofautoimmune diseases, we have launched numerous new products.
Withpolymyositis

anddermatomyositis/autoimmune

bullousdisease in particular, Japanese researchers have taken a global
lead in both treatment and testing and have drawn up diagnosis
standards and treatment guidelines for Japan. The infrastructureis therefore in place for the production of world-class products.

Molecular diagnostic ReagentsIn the development of genetic diagnostics, we have installed
cutting-edge technology such as next-generation sequencers toenable us to provide the medical community with rapid and highly
sensitive clinical diagnostics that provide genetic informationthat can aid in the diagnosis of cancer or infectious diseases andis useful in the development of personalized medicine.

Reagents for Research Use
Niche Factors for 3D Cell Culture
Organoids are miniature organs developed in vitro from pluripotent
stem cells such as stem cells derived from the living organism
and iPS cells. Organoid technology has started to be used in basic
research, drug discovery research, and regenerative medicine. We havedeveloped and marketed organoid-related products such as growth
factors for addition during organoid culture.

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To provide the required diagnostics to the medical industry as soon as possible, we carry out the seriesof tasks from planning clinical performance study and application for approval of in vitro diagnostics
to procedures for insurance coverage as a uniﬁed process.
Through close cooperation with the medical community, we strive to make innovative diagnostic
reagents a reality.

Links with KOLs

MBLʼs Strengths

Autoimmune Diseases
We have collaborated with domestic KOLs to launch numerous products in the ﬁeld of autoimmune diseases. With
polymyositis and dermatomyositis / autoimmune bullous disease in particular, Japanese KOLs have taken a global
lead in both treatment and testing and have drawn up diagnosis standards and treatment guidelines for Japan.

Genes
MBL is the only in vitro diagnostics manufacturer to participate in SCRUM-Japan*. With the advice of medical
doctors who have a wealth of experience in new drug development, we will able to develop IVD / CDx products toobtain approval and insurance coverage from regulatory authority.
*SCRUM-Japan is the ﬁrst ever nationwide cancer genome screening project carried out through industry‒academia collaboration. It came about through themerger of LC-SCRUM-Japan, a genetic screening network for rare lung cancers, and GI-SCREEN-Japan, a genetic screening network for bowel cancer.

New Product Development

MBLʼs Strengths

Number of Clinical Diagnostics Coveredby the Japanese Health Insurance System
Applications for diagnostics to be covered by the health insurance system fall into three categories: E1, E2, and E3. E1
is diagnostics with previously existing measurement items and measurement methods, E2 is diagnostics with newmeasurement methods, and E3 is diagnostics with new measurement items. At MBL, we work with all three categories,
but we are particularly strong in E3.
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No. of cases
Number of category E3 diagnostics coveredby the health insurance system from Feb 2003 to Feb 2023

15

10

5

0

MBL
09

A

B

C

D

E

F

G

H

I

J

K

L

M

N

O

P

Q

R

S

T

U

V

CompanyStable Supplies of High-Quality, Safe,
Reliable Products
Our R&D division and Production divisions collaborate to develop and improve manufacturing methods and toensure high productivity in the manufacture of in vitro diagnostics and their raw materials. With this manufacturing
technology infrastructure as a base, we are able to ensure stable supplies of our products. We presently have alineup of around 75 in vitro diagnostics on the market, and we conduct over 1,000 performance tests every year.

Basic Process for Production of In Vitro Diagnostics
Procurement of
raw materials

Manufacture ofreagents

Receiving inspection of
raw materials

Testingby Quality Control Oﬃce

Internal testingby Production Department

Shipping

In-house manufacture of raw materials such as antigen antibodies, etc., and purchase of ingredients

Quality Management System
MBL has obtained ISO13485 certiﬁcation, and constantly strives to improve product quality through the following
quality policies:

1

We shall maintain and continually improve the eﬀectiveness of the quality
management system and deliver customer-oriented quality.

2

We shall listen to the information from customers and carefully and promptly
make responses.

3

We shall give ﬁrst priority to the compliance with the laws and regulatory
requirements and deliver safe and secure products and services.

10Symposiums
Autoantibodies and Autoimmunity Symposium
We have hosted this symposium 30 times since 1993, inviting participants from Japan and overseas.

Takato Molecular Cell Biology Symposium
We have hosted this symposium every August since 1989, with the 34th symposium in 2023.

Publications
Diagnostic Criteria and Treatment Guidelines for
Autoimmune Diseases
We have published a booklet with the latest information
on diagnostic criteria and treatment guidelines for
autoimmune diseases. The booklet includes a test
ﬂowchart, a checklist of the main clinical symptoms, andautoantibody test items, which are all presented in a
way that can be readily understoodby doctors who do not specialize
in collagen-vascular diseases. The
booklet will serve as a guideline for
medical treatment and is intended
to be useful for clinical practice.

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E ve nt s

1969

P ro du c ts

Company founded with the aim of
becoming Japanʼs ﬁrst antibody manufacturer(Start of antiserum business)

1975

Expansion into clinical diagnostics ﬁeld

1977

Commenced development ofDevelopment and marketing of Enzyme

autoimmune disease diagnostics

ANA Test, the ﬁrst domestically produced
antinuclear antibody (ANA) detection reagent

1987

Expansion into ﬁeld of reagents forDevelopment/marketing of ﬁrst ELISA

basic research

reagent for autoantibody testing

MESA series EIA reagent

1999
2005

Entry into molecular diagnostics ﬁeld
G&G Science Co., Ltd. founded
Joint corporation, Beijing B&M Biotech Co., Ltd. founded in Beijing, China.
(as of now MBL Beijing Biotech Co., Ltd.)

2010
2015

Development / marketing of
STACIA MEBLux TM Test
MBL came under umbrella of JSR Group2018

Launch of MEBGEN RASKET TM-B kit

2020

MBL Shenzhen Biotech Co., Ltd. founded in Shenzhen, China

2021

MBL became fully owned subsidiary ofStrengthening of drug discovery support ﬁeld

JSR Corporation

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Ina Laboratory

Domestic Bases(1 s t Manufacturing Facility /2nd Manufacturing Facility)

Headquarters

Fukushima Laboratory(Gene reagent development)

Tsukuba Laboratory

SUMITOMO FUDOSANSHIBADAIMON NICHOME BLDG.

Overseas Bases
Products and services are provided in collaboration with overseas Group member companies and aﬃliates.

MBL Beijing

JSR Life Sciences

Sales of raw materials forin vitro diagnostics

Polymer-based diagnostics
and particles for therapeutic
antibody puriﬁcation business

MBL Shenzhen

Crown Bioscience

Manufacturing and sales ofin vitro diagnostics

Global contract researchorganization providing preclinicaland translational platforms to
support drug discovery

Company Overview
Company name :MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.

Headquarters : SUMITOMO FUDOSAN SHIBADAIMON NICHOME BLDG.

2-11-8 Shibadaimon, Minato-ku, Tokyo
105-0012 Japan
Telephone : +81-3-6684-6860 (Main)
Fax : +81-3-6854-3615
Founded : August 23, 1969
CEO :Hiroki Ito

Number of Employees : 474 (As of March 31, 2023)

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Our corporate policy is to contribute our innovative diagnostic technology to people's health andmedical development. On this basis, we create value through our corporate activities, and we arecommitted to ensuring the sustainability of the environment and of society. We also promote
activities that contribute to all our stakeholders̶our customers and business partners, ouremployees and shareholders, society, and the environment. As a member of the JSR Group, wedeﬁne sustainability as contributing to society by creating value through our corporate activities.

Providing Opportunities for Sharing Information
Every year we host the Autoantibodies and Autoimmunity Symposium in the clinical ﬁeld
and the Takato Molecular Cell Biology Symposium in the basic research ﬁeld. We invite not
only doctors but also high school and university students aspiring to become doctors toparticipate in these symposiums, and thus provide forums for the development of medicine
and communication with the next generation of medical professionals.

Comfortable Work Environment
We have many female employees playing active roles in the company. Thereis a 50-50 gender ratio at all our business facilities, with women accountingfor 60% of staﬀ at Ina Laboratory. In addition, 23% of management staﬀ are
women. The average number of hours of overtime in ﬁscal 2022 was below
the legal limit of 45 hours per month.

Operation of Environmental Management Systems
We have received stepwise certiﬁcation under the Ministry of the Environmentʼs Eco-Action 21 environmental
management system, and by putting the environmental management set out in the guidelines into practice, we
are achieving a high level of environmental friendliness in our corporate activities.

認証･登録番号 0012076

Laboratories/ :manufacturing plants[ Ina Laboratory ]Delivery Center : 3F Stage 3 North Building,< 1st Manufacturing Facility >Goodman Business Park1063-103 Terasawaoka, Ina, Nagano

2-2 Kaguro Minami, Inzai City, Chiba

396-0002 Japan

270-1369 Japan< 2nd Manufacturing Facility >1018-1 Terasawaoka, Ina, Nagano
396-0002 Japan[ Tsukuba Laboratory ]JSR Tsukuba Research Laboratories
25 Miyukigaoka, Tsukuba-shi, Ibaraki
305-0841 Japan

Group companies :[ China ]< MBL Beijing Biotech Co., Ltd. >< MBL Shenzhen Biotech Co., Ltd. >[ Japan ]< G&G Science Co., Ltd. >< Crown Bioscience & MBL Co., Ltd. >Published December 2023

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