MEDICAL-BIOLOGICAL UNION Holding, inc. Holding inc_.pdf · Automated immunoanalyzer Elisa 9 Analyzer Eliza –the very first Russian robotic device for automated mass testing based

16 Inzhenernaya st., Novosibirsk, 630090 Russia+7 (383) 363-77-14

http://[email protected]

MEDICAL-BIOLOGICAL UNION Holding, inc.

http://mbu.ru/

mailto:[email protected]



MEDICAL-BIOLOGICAL UNION Holding

Medical-biological Union (MBU) – the main company of MBU holding, one the very first

private biotech companies on the Russian market, founded in 1992.

Our mission

To develop and to launch science-intensive businesses in biotech and medicine field.

More than 150 employees in MBU holding.

More than 20 projects and businesses in the portfolio of MBU holding.

2

http://mbu.ru/




Our expertise

Project development and project management for science-intense projects.

Management of R&D, scaling-up, production and market launch.

Internal R&D division of MBU Holding.

Established channels of communication with scientific institutions of Siberian branch ofRussian Academy of Sciences with an aim of locating new ideas, researches and

projects.

Industrial expertise:

IVD and diagnostic platforms;

equipment for IVD;

personalized medicine;

biopharma;

Industrial biotech.

3

http://mbu.ru/




Structure of MBU Holding

4

MBU project office

Pilot center

PROMBIOTECHMBU-Technology

Contract and own

manufacturing

Engineering

companies

High-tech

businesses

Local and global markets

http://mbu.ru/




MEDICAL-BIOLOGICAL UNION

Main company of the group

5

Medical-biological Company more than 25 years on the market of in-vitro diagnostics (IVD).

Functions

Project office of MBU Holding

Diagnostic kits for the detection of human diseases, state biological standards and laboratory equipment manufacturing.

Contract manufacturing of equipment for diagnostic kits and reagent kits.

Production facilities

ISO 9001- and ISO 13485-certified facilities for the manufacturing of medical devices and medical equipment.

Facilities, licensed for work with pathogenic microorganisms.

Product rangeMore than 50 types

Personnel – 75 empoyees.

http://mbu.ru/




MBU-Technology

IVD-engineering companyMBU-Technology

More than 12 years of research and development in IVD and personalized medicine fields.

Expertise

Development and management of IVD projects;

Personalized and telemedicine;

Development of products based on diagnostic platforms (ELISA, PCR, etc.);

Biosensors.

Licensed facilities as clinical laboratory.

Personnel – 20 employees.

Projects in the portfolio – 7.

6

http://mbu.ru/




Pilot center PROMBIOTECHEngineering for industrial biotech projects

7

Pilot center PROMBIOTECH

Joint project of MBU, Sibbiopharm and Academpark.

Expertise

Development and management of industrial biotech projects;

Contract manufacturing;

R&D of fermentation, purification and finishing technologies.

Key project in the portfolio

Organization of large-scale drilling fluid components production for oil & gas and food industries.

http://mbu.ru/




Core projects

National quality control system

The company created a new market for quality control materials

in Russia, offering its own solution to the Russian market - national

standard serum panels.

The development was carried out jointly with the specialists of

the Vector National Virology Institute and the State Institute of

Standardization and Control; production is carried out entirely on

the basis of the MBU site.

Now the company's products in this market occupy more than

20%.

8

http://mbu.ru/




Core projects

Automated immunoanalyzer Elisa

9

Analyzer Eliza – the very first Russian robotic device for automated

mass testing based on ELISA technology.

The company managed to achieve significantly lower cost of the

analyzer with comparable capacity and performance in

comparison with foreign analogues.

Status

− Received approval from Russian medical devices market

regulator at the end of 2017.

− In 2018, an industrial production was launched in Novosibirsk.

Product is based on original domestic technological solutions

and software.

− Currently shipping all around Russia.

http://mbu.ru/




Core projects

Hematologic control materials «Hematrol 5D»

10

Hematrol 5D – the first Russian control materials for hematological

5diff analyzers has been developed, the production and shipment

of controls launched. These controls are widely used by diagnostic

laboratories throughout the country is started.

Level of quality of Hematrol 5D is in line or exceeds the properties of

the original hematologic control materials.

Status

− Received approval from Russian medical devices market

regulator in 2017.

− Established industrial production in 2018 at the MBU Holding

facility in Novosibirsk.

− Currently shipping all around Russia.

http://mbu.ru/




New diagnostic and product platforms

Portable blood coagulation monitoring system

11

The blood coagulation analyzer is a unique Russian portable solution

for measuring INR (PV) parameters at home.

The device has an intuitive interface and allows the patient to

synchronize measurement data with medical information systems

(MIS). The solution has a lower cost of the device and consumables

in comparison with foreign counterparts.

Original platform allows further development of various types of the

devices for measuring of a whole range of biochemical and other

blood parameters.

http://mbu.ru/





Ultrafast blood groupng

12

The technology in the form of test systems of a size of a credit card

allows performing of a blood grouping in a few seconds without

prolonged sample preparation. It is able to determine blood groups

in accordance with various systems in the field or laboratory

conditions.

− Only 1 drop of capillary blood for measuring

− Just 15 seconds for a whole analysis

− No need for a sample preparation – the patient’s blood is added

directly to the test system

− The technology works for any blood condition – whole capillary,

venous, canned

− The main element of a test system the size of a bank card

− The technology allows a development a reliable high-

performance system for laboratory use

http://mbu.ru/





Isothermal PCR

13

Original technology for the qualitative identification of pathogens

based on the Isothermal PCR methodic

The technology allows creation of a cheap highly sensitive portable

devices for ultrafast detection of pathogens of viral, bacterial,

fungal and parasitic diseases for field and home usage .

The detection rate is much higher than the closest competitors with

comparable sensitivity, the test does not require complex sample

preparation, and the device can be designed in a compact case.

http://mbu.ru/





Genetic testing for humans and animals

14

The group of companies develops and provides services for the

genetic testing of people (non-medical genetics) and animals

(veterinary genetics).

MBU has all the necessary competencies for the scientific

development of the gene panel, the selection of reagents and the

conduct of mass genetic testing of incoming biomaterial in the

internal clinical laboratory.

In the segment of human genetics, MBU’s efforts are concentrated

on non-medical genetics, which represents a growing sub-segment

in Russia and all over the world.

http://mbu.ru/




Status Short description

Econova

Development of products for

scientific research, bio-

pharmaceutics.

Development and manufacturing of

portable HPLC systems. These systems

operates without the use of standard

samples and suitable for use in the field.

DART

(Diversion &

Abuse Resistant

Technology)

Obtained successful results pre-

clinical trials, the FDA dossier is

being prepared. An investment

proposal has been prepared.

The technology of protecting drugs from

codeine extraction and other types of

abuse. The technology was developed by

order of the USA drug market.

Noogen

Submission of applications for

patents in the US, South Korea,

China, USA, Japan.

Pre-clinical trials are under way.

New class of DNA and RNA analogues as

a new antisense-based drug discovery

platform

Other projects

15

http://mbu.ru/




Interactions with Novosibirsk scientific and

research institutions

MBU Holding carries out the development, packaging and promotion of joint

projects in cooperation with leading scientific research institutes of the

Siberian Branch of the Russian Academy of Sciences

16

Cytology and

Genetics Institute

SB RAS

Novosibirsk

Institute of

Organic

Chemistry SB RAS

Institute of Chemical

Biology and

Fundamental

Medicine

SB RAS

Novosibirsk Institute of

Clinical and

Experimental

Medicine

SB RAMS

Institute of

Semiconductor

Physics SB RAS

Institute of

Molecular and

Cell Biology

SB RAS

http://mbu.ru/




Social activities

Non-profit partnership SibBioMed

Non-profit union, holding together more than two dozens of organizations such as private companies, scientific and educational institutions.

MissionTo use all available resources, competencies and connections of participants for realization of joint projects, successful fund raising and for establishing of a dialogue with regional and federal government officials.

Areas of activity• IVD/ in vitro diagnostics;

• industrial biotech;• agricultural biotech.

17

Educational project MBU-kids

Unique cases for learning the basics of molecular biology and medicine.

MBU-kids cases allow to

To visually and deeply explain the current scientific problems in the field of biotechnology to schoolchildren:

• development of diagnostic tests,

• the nature of an immune response and vaccination,

• the gene polymorphisms,

• search for medicinal compounds in plants, and so on.

To master the most popular research technologies used in scientific and diagnostics laboratories:

• ELISE,

• PCR,

• HPLC.

http://mbu.ru/




Core team

18

Maria Galyamova

Project director

Academpark

More than 15 years of experience

in engineering of biotech and IVD

projects

Mikhail Losev

Director and founder of

Medical-biological Union

Holding inc.

Serial Entrepreneur.

Founder and owner of more than

dozen innovative businesses.

Andrey Tronin

Director

MBU-Technology, LLC

More than 15 years of experience

in R&D of the development of

diagnostic tools for human

infectious diseases.

http://mbu.ru/




Our key partners

19

http://mbu.ru/


Documents

MEDICAL-BIOLOGICAL UNION Holding, inc. Holding inc_.pdf · Automated immunoanalyzer Elisa 9 Analyzer Eliza –the very first Russian robotic device for automated mass testing based