BEC - 590 Interactive facility poster
Shivani
Created on November 20, 2023
Here are all the modifications we intend to make to the existing BTEC department building at NC State University to make it suitable for the production of the estimated scale of Rituximab Biosimilar that is proposed in our project.
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Transcript
Select a level to get started on the virtual facility tour- Shivani Sutrave Catherine MathesHaroon DarArshad Ahmed
Interactive poster
Rituximab Biosimilar Production Facility
Click here to view the facility's first floor.
Click here to visit the facility's floor 2.
This is the first floor of BTEC. As we enter through the doors we step into the Lobby which we have not touched, The drug substance moves from the Production suite into the Harvest, Protein A, Viral inactivation, CEX, AEX , viral filtration and bulk fill suites. All this movement is sequential and follows all the cGMP flows and regulations by the FDA.
Floor 1
200 L Reactors ( x 6 )
200 L Reactors ( x 4 )
Buffer and media prep room
autoclave/ equipment sterlization room
harvest
Protein A chromatography
Viral Inactivation
cation exchange chromatography
Lobby
waste management
bulk fill room
viral filtration
anion exchange chromatography
Autoclave/Equipment Sterilization room Sterilization Room features AMSCO® Evolution™ Floor Loader Steam Sterilizer, processing 25 trays/cycle, double door for pass-through, ensuring efficient, safe floor-loading of high-capacity carts. It will have the following equipment:
- Steris GMP Autoclave
- Steris Decon Autoclave
- Branson Sonicator
- Lancer parts & glass washer
Waste Management All waste is processed here. Provides temporary storage of infectious waste or combustible material.
200 L Reactors ( x 6 )
200 L Reactors ( x 4 )
Buffer and media prep room
autoclave/ equipment sterlization room
harvest
Protein A chromatography
Viral Inactivation
cation exchange chromatography
Lobby
bulk fill room
viral filtration
anion exchange chromatography
waste management
Floor 1
Floor 1 - Personnel Flow
200 L Reactors ( x 6 )
200 L Reactors ( x 4 )
Buffer and media prep room
autoclave/ equipment sterlization room
harvest
CEX
waste management
viral filtration
AEX
Protein A chromatography
Lobby
Viral Inactivation
bulk fill room
Floor 1 - Personnel Flow
200 L Reactors ( x 6 )
200 L Reactors ( x 4 )
Buffer and media prep room
autoclave/ equipment sterlization room
harvest
CEX
waste management
viral filtration
AEX
Protein A chromatography
Lobby
Viral Inactivation
bulk fill room
Floor 1 - MATERIAl Flow
200 L Reactors ( x 6 )
200 L Reactors ( x 4 )
Buffer and media prep room
autoclave/ equipment sterlization room
harvest
CEX
waste management
viral filtration
AEX
Protein A chromatography
Lobby
Viral Inactivation
bulk fill room
This is the second floor of the BTEC facility. Here we have the seed train expansion suites right across the stairs, buffer prep areas, training classrooms for our personnel, PAT section and offices for our employees.
Floor 2
250 ml shake flasks/ vial thaw
conference
2 l shake flasks
5 l bioreactors
20 L bioreactors
buffer formulation /prep
cold storage room
custodial
qc teaching lab
bioreactor instructional lab
storage
autoclave
training room
instructional lab
equipment sterlization
offices
pat
Spectroscopy
microscopy suite
servers
Imaging Suite
Analytical Chromatography
Floor 2
250 ml shake flasks/ vial thaw
conference
2 l shake flasks
5 l bioreactors
20 L bioreactors
buffer formulation /prep
cold storage room
custodial
qc teaching lab
bioreactor instructional lab
storage
autoclave
training room
instructional lab
equipment sterlization
offices
Spectroscopy
microscopy suite
servers
Imaging Suite
Analytical Chromatography
250 ml shake flasks/ vial thaw
conference
2 l shake flasks
5 l bioreactors
20 L bioreactors
buffer formulation /prep
cold storage room
custodial
qc teaching lab
bioreactor instructional lab
storage
autoclave
training room
instructional lab
equipment sterlization
offices
Spectroscopy
microscopy suite
servers
Imaging Suite
Analytical Chromatography
Floor 2 - Personnel Flow
This is the second floor of the BTEC facility. Here we have the seed train expansion suites right across the stairs, buffer prep areas, training classrooms for our personnel, PAT section and offices for our employees.
250 ml shake flasks/ vial thaw
conference
2 l shake flasks
5 l bioreactors
20 L bioreactors
buffer formulation /prep
cold storage room
custodial
qc teaching lab
bioreactor instructional lab
storage
autoclave
training room
instructional lab
equipment sterlization
offices
Spectroscopy
microscopy suite
servers
Imaging Suite
Analytical Chromatography
Floor 2 - material Flow
250 ml shake flasks/ vial thaw
conference
2 l shake flasks
5 l bioreactors
20 L bioreactors
buffer formulation /prep
cold storage room
custodial
qc teaching lab
bioreactor instructional lab
storage
autoclave
training room
instructional lab
equipment sterlization
offices
Spectroscopy
microscopy suite
servers
Imaging Suite
Analytical Chromatography
Floor 2 - material Flow
Basement - Personnel Flow
Basement - Personnel Flow
Basement - Material Flow
Basement - Material Flow
This room will have an ISO 5 classified section as depicted. The eluate from the polishing chromatography steps is brought in here in bags, and processed in the ISO 5 sterile area and sent out to FujiFilm Diosynth for the final fill process. This room will have:
Bulk Fill Room
- Allegro Connect Bulk Fill System (1)
- ASI Aseptic Single-Use Filling System Model 4MP6000
- Watson Marlow 620 Di/R Pump
- Millipore M Air T air testing system (2)
- Climet CI-150t particle counter (2)
- Heraguard ECO Clean bench (2)
We will have the following main equipment here:
- Millipore ETU TFF skid (2)
- Millistak+ Pod Filter Holder (2)
- Millistak+ HC Pro Pods
- Parvovirus retentive filter
Viral Filtration
We will prepare all buffer/ media required throughout the processes in our facility in this room. This room will have the following main equipment:
Buffer Formulation/Prep
- Feldmeier Media Prep tank V-4150 400 L
- Feldmeier Buffer prep tank V-4100 600 L
- Hyclone Mobius Mixer MX-1530 200 L
- Fisher refrigerator RF-1530
- Puffer Hubbard Freezer (3)
- Chemical fume hood
- Steril Gard II biosafety cabinet
- Watson Marlow 520s/R2 pump
- Sartocheck 4 integrity tester
- Ohaus scale (4)
- Fisher heat/stir plate (4)
- Hyclone stir plate
This is our (n-1) production suite. We have the following equipment in here:
20 L Bioreactor Suite
- Sartorius BIOSTAT Cplus 20L Bioreactor (10)
- Spare tubing + connectors
- Fisherbrand™ accumet™ Basic AB330 Conductivity/TDS/Salinity Benchtop Laboratory Meter
- Mettler Toledo FiveEasy Conductivity meter F30-Std-Kit
- BioPAT Trace Glucose/Lactate Measurement
- Computer with BioPAT MFCS SCADA software
- 50mL conical sampling tubes
- Biohazard waste bag and bin
- 4 degree C fridge
This is where the WCB will be thawed. We will have the following equipment in here:
250 mL Shake Flasks/Vial Thaw
- 250 ML ERLENMEYER CELL SHAKER FLASK ( x 30)
- Infors HT Mulitron Shaking Incubators (x 3)
- Pipette set
- Biohazard waste bag and bin
- Biological Safety Cabinets (2)
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The CCF from the Production step is transfered to this room in carboys. Here our desired secreted protein is removed from the cells and cell debris using a disc stack centrifuge, followed by depth and membrane filtration steps. This will have the following:
Harvest
https://www.biopharminternational.com/view/harvest-and-recovery-monoclonal-antibodies-large-scale-mammalian-cell-culture
- Membrane filtration system
- Alfa Laval Disc stack centrifuge (1)
- Millistak+ HC Pro Pod Depth Filter C0SP
- MCE Membrane Filter, 0.22 um
- Carboys
Centrifugation separates solids based on density. Post-centrifugation, cell culture fluid undergoes depth filtration, removing larger contaminants before microfiltration, preventing quick clogging, termed prefiltration.
After depth filtration, the refined Cell Culture Fluid (CCF), with reduced particulates, undergoes Tangential Flow Filtration. This technique yields a particle-free harvest stream, minimizing the need for additional filtration.
This is the new floor plan for the 2nd floor in this facility, navigate through different flows for 2nd floor with the icons below
Welcome to our rituximab biosimilar Facility
Basement Material Flow
Basement Personnel Flow
Material Flow
Personnel Flow
The CEX pool is brought in carboys to this room & processed through AEX column. The AEX will operate in the flow through mode and it will be the second step in our polishing chromatography processes. This room will have:
Anion Exchange Chromatography Suite
- TOYOPEARL NH2-750F resin
- BPG Glass 300/500 column and skid (11)
- Sterile disposable bags
- Sterile tubing and gaskets
This room will have the following equipment:
Spectroscopy
- DXR3 Flex Raman Spectrometer
- Orbitrap Exploris™ 120 Mass Spectrometer
- Fisherbrand™ accumet™ Basic AB330 Conductivity/TDS/Salinity Benchtop Laboratory Meter
- Biohazard waste bag and bin
The filtered VI pool is processed through an CEX column. The CEX operates in bind and elute mode, and we have 10 BPG Glass columns in this room processing in multiple cycles. This room contains the following equipment:
Cation Exchange Chromatography
- TOYOPEARL Sulfate-650F resin
- BPG Glass 300/500 column and skid (11)
- Sterile disposable bags
- Sterile tubing and gaskets
This room will have the following equipment:
Analytical Chromatography
- Sartorius PATfix
- GE AKTA AVANT 150 CHROMATOGRAPHY SYSTEM
- GE AKTA AVANT 25 CHROMATOGRAPHY SYSTEM
- Sterile disposable bags
- Sterile tubing and gaskets
- Biohazard waste bag and bin
This is the new floor plan for our facility.
Welcome to our rituximab biosimilar Facility
Floor 2 Layout
Material Flow
Personnel Flow
This room will have the following equipment:
- Steris GMP Autoclave
- Steris Decon Autoclave
- Branson Sonicator
- Lancer parts & glass washer
Equipment Sterilization room
Using ten Biostat D-DCU 200L twin Bioreactors with CIP and SIP, our production process in the 2 production suites culminates in Cell Culture Fluid transfer to the Harvest room.
200 L Bioreactor Suite
- Biostat D-DCU 200L Bioreactors
- Hartel CIP Skid
- Denver Instruments pH/conductivity meter
- Thermo Scientific UV Spectrophotometer
- Nuaire biological safety cabinet
- New Brunswick Scientific incubator shaker
- YSI Biochemistry analyzer
- Scientific instruments vortex
- Biohazard waste bag and bin
The HCCF is transferred here. ProA uses reversible and specific binding between immobilized protein A ligand and antibodies, it retains antibodies on the column, allowing elution in a purified and concentrated form. This room has the following equipment:
Protein A chromatography
- TOYOPEARL AF-rProtein A HC-650 Resin
- Cytiva BPG Glass 300/500 Column and skid (11)
- Sterile disposable bags
- Sterile tubing and gaskets
The proA eluate is subjected to viral inactivation which inactivates potential adventitious enveloped viruses by low pH treatment, incubation and the pH is readjusted and filtered. This room has the following equipment:
Low pH Viral Inactivation
- Millipore ETU TFF skid
- Millistak+ Pod Filter holder
- Millistak+ HC Pro Pods
This is the new floor plan for our facility.
Welcome to our rituximab biosimilar Facility
Floor 2 Layout
Material Flow
Back to Floor 1
This is the new floor plan for the 2nd floor in this facility, navigate through different flows for the 2nd floor with the icons below
Welcome to our rituximab biosimilar Facility
Floor 1 Layout
Material Flow
Personnel Flow
This room will have the following:
- Cytation 5 system
- Thermo Scientific™ NanoDrop Lite Plus Spectrophotometer (2)
- Biohazard waste bag and bin
Imaging Suite
This room will have:
Microscopy suite
- Cytation 5 system
- Viranova Bioanalytics mini-TEM
- Micropipette set
- Biohazard waste bag and bin
The server room will encompass:DELL PowerEdge R7525 Rack Server (x15) 25U Server rack Uninterrupted Power Supply
Servers Room
This room employs the following equipment:
5 L Bioreactors
- Sartorius BIOSTAT Cplus 5L Benchtop Reactors (15)
- Biological safety cabinet
- Micropipette set
- 2mL sampling syringes
- 4-degree C fridge
- Biohazard waste bag and bin
We will transfer the cells to this room for scale-up. These are the main equipment in this room:
2 L Shake Flasks
- 2L Erlenmeyer Flask w/ Vent Cap, Polycarbonate, Sterile (x 24)
- Infors HT Mulitron Shaking Incubators (x 3)
- Pipette set
- Biohazard waste bag and bin
- Biological Safety Cabinets (2)
This is the new floor plan for the Basement in this facility, navigate through different flows for the basement with the icons below
Welcome to our rituximab biosimilar Facility
Basement Personnel Flow
Floor 1 Layout
Floor 2 Layout
Basement Material Flow
Any extra cold storage requirements will be met here. This room will have the following equipment:
Cold Storage room
- Fisher refrigerator RF-1530
- Puffer Hubbard Freezer (x 2)
- Steril Gard II biosafety cabinet
Our buffer room formulates diverse buffers crucial for upstream processes, regulating pH, optimizing cell growth, and preserving protein functionality during primary recovery in preparation for purification. It will have the following equipment:
- Feldmeier Media Prep tank V-4150 400 L
- Feldmeier Buffer prep tank V-4100 600 L
- Hyclone Mobius Mixer MX-1530 200 L
- Fisher refrigerator RF-1530
- Puffer Hubbard Freezer (3)
- Chemical fume hood
- Steril Gard II biosafety cabinet
- Watson Marlow 520s/R2 pump
- Sartocheck 4 integrity tester
- Ohaus scale (4)
- Fisher heat/stir plate (4)
- Hyclone stir plate
Buffer / Media Prep room
This is the new floor plan for the Basement in this facility, navigate through different flows for the basement with the icons below
Welcome to our rituximab biosimilar Facility
Basement Personnel Flow
Floor 1 Layout
Floor 2 Layout
Basement Material Flow