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Brochure MIRCOD BIOTECH June 20 2022 NO NDA
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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
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
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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
mircodbiotech.com
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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
mircodbiotech.com
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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
mircodbiotech.com
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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
mircodbiotech.com
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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
mircodbiotech.com
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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
mircodbiotech.com
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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
mircodbiotech.com
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