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Brochure MIRCOD BIOTECH June 20 2022 NO NDA

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Brochure MIRCOD BIOTECH June 20 2022 NO NDA

Biotech

Poc system

Completely closed and safe production

Automation of production processes

Comprehensive real-time process monitoring

System of notifications and alerts

High efficiency of reagent use

The option to use multiple identical devices simultaneously

[email protected]

mircodbiotech.com

3

Biotech

Poc system

T cells transduction w it h C D19 lenti v irus

IPC: B-cells impurity, Viability, Cell count

DAY 0

Blood withdraw

Lymphoma patient

PBMCs isolation

PBMCs activation in T75 flask (20ml)

50x10 6 T-cells are transduced in T25 flask (5ml)

DAY 2

IPC: Viability, Cell count

DAY 10

Th erapy administration to t h e patient 60 - 600 x 106 C AR - T s fixed dose (E stimated 60 - 120 ml )

Lentivirus wash and cell expansion in G-REX

DAY 3

DAY 9

DAY 4-8

IPC: Viability, Cell count

Process automatio n using Conical Bioreactor

CAR-T therapy

LOVO Cell processing to final formulation

CD19-CAR-T cells expansion medium refreshment depends on Glu/Lact

Day 5

of fi ce @ mircod . com

Sterility, endotoxin, mycoplasma

mircod b iotech . com

4

Biotech

ULTRAFILTRATION AND CONCENTRATION

Cell Expansion in Stirred Bioreactor

DAY 0

DAY 4

DAY 6

DAY 7

DAY 7

Inoculation of cells to the stirred Bioreactor

Transfection, perfusion start 4-6 hours post-transfection

48 hours sampling

72 hrs pooling of collect media

Ultrafiltration

[email protected]

mircodbiotech.com

8

Biotech

ASYMMETRIC CONICAL BIOREACTOR

T cells transduction wit h C D19 lentivirus

IPC: B - cells impurity, Viability, Cell count

DAY 0

Blood withdraw

Lymphoma patient

PBMCs isolation

PBMCs activation in T75 flask (20ml)

50x10 6 T-cells are transduced in T25 flask (5ml)

DAY 2

IPC: Viability, Cell count

DAY 1 0

In current manual process Conical Bioreactor vessel is used. Conical Bioreactor allows to automate cell expansion step

Lentivirus wash and cell expansion in G-REX

Th erapy administration to t h e patient 60-600 x 106 C AR-T s fixed dose (E stimated 60-120 ml )

DAY 3

Lentivirus wash and cell expansion in G-REX

DAY 9

DAY 4-8

IPC: Viability, Cell count

Process automatio n using Conical Bioreactor

CAR-T therapy

LOVO Cell processing to final formulation

CD19-CAR-T cells expansion medium refreshment depends on Glu/Lact

Day 5

of fi ce @ mircod . com

Sterility, endotoxin, mycoplasma

mircod b iotech . com

17

Biotech

Single-Use Perfusion Bioreactor

T cells transduction wit h C D19 lentivirus

IPC: B - cells impurity, Viability, Cell count

DAY 0

Blood withdraw

Lymphoma patient

PBMCs isolation

PBMCs activation in T75 flask (20ml)

50x10 6 T-cells are transduced in T25 flask (5ml)

DAY 2

IPC: Viability, Cell count

DAY 1 0

In current manual process Conical Bioreactor vessel is used. Conical Bioreactor allows to automate cell expansion step

Lentivirus wash and cell expansion in G-REX

Th erapy administration to t h e patient 60-600 x 106 C AR-T s fixed dose (E stimated 60-120 ml )

DAY 3

Lentivirus wash and cell expansion in G-REX

DAY 9

DAY 4-8

IPC: Viability, Cell count

Process automatio n using Conical Bioreactor

CAR-T therapy

LOVO Cell processing to final formulation

CD19-CAR-T cells expansion medium refreshment depends on Glu/Lact

Day 5

of fi ce @ mircod . com

Sterility, endotoxin, mycoplasma

mircod b iotech . com

21

Biotech

Cooling Unit

New reagent detected: Formulation buffer.

12 °С

Reagents supply to the different types of bioreactor depending on the process requirement

5 ml of Media

150 ml of Washing Buffer

[email protected]

mircodbiotech.com

25

Biotech

Gas Mixing Station

USA 2295 NW Corporate Blvd, ste #110, Boca Raton, FL, 33487 +1 (772) 307-9921

Europe 61 Matisa street, A-20 Riga, Latvia +1 (561) 699-5636

[email protected]

mircodbiotech.com

27

Biotech

Gas Mixing Station

5% CO2 Mix

N2

 Maintenance of CO2 level during different biological processe  Oxygenation level maintaning in order to keep cells oxygen-enriched

 Pressurizing a closed vessel with NF

 Supply of pure gases (or gas mixtures) for any other medical purposes

[email protected]

mircodbiotech.com

30

Biotech

Robotic Arm

USA 2295 NW Corporate Blvd, ste #110, Boca Raton, FL, 33487 +1 (772) 307-9921

Europe 61 Matisa street, A-20 Riga, Latvia +1 (561) 699-5636

[email protected]

mircodbiotech.com

32

Biotech

Robotic arm

Automation of production processes

6 degrees of freedom

Load up to 10 kg

Working area of 1 m

Working feed speed up to 1 m/s

Protection class IP54

The ability to install different grippers

The option to install the device on a movable platform

[email protected]

mircodbiotech.com

34

Biotech

Robotic arm

0 Assembling the bioreactor in a specific sequenceT

0 Assembling the UCU in a specific sequenc6

0 Continuous 24/7 control of each POC cell in the cell culturing facilityT

0 Rinsing and disinfecting the bioreactoV

0 Rinsing and disinfecting the UC)

0 Cell installation and maintenance in POC syste^

0 Precise dosage of component[

0 Tilting the UCU during the stage of harvestin/

0 Cartridge change in POC systemT

0 Predetermined rolling trajectory of the bioreactorT

0 Controling process parameters (such as pressure, process time, certain stages duration etc.

0 Rinsing and cleaning of POC devices outside and inside

0 Automatic control of bioreactor 24/7T

0 Automatic control of UCU 24/

0 Packaging of end products

0 Packaging of end products

[email protected]

mircodbiotech.com

35