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    Fully Integrated, Scalable, cGMP Cell Therapy Manufacturing Platform

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    HIGH THROUGHPUT

    Purpose-built Technology Powers the First Integrated Development & Manufacturing Organization (IDMO)

    Reagent Vault System (RVS)

    • Capacity for up to 200 automation-friendly reagent bottles (SLTDs)
    • SLTDs come in three volumes: 10mL, 50mL, 1000mL
    • Reagent agnostic (all vendors supported)
    • Refrigerated at 4°C
    • Just in time lane for time critical reagent delivery
    • Integrated software for reagent scheduling, inventory and supply chain management
    • All SLTDs undergo ionized hydrogen peroxide decontamination cycles

    Reagent Vault System (RVS)

    • Capacity for up to 200 automation-friendly reagent bottles (SLTDs)
    • SLTDs come in three volumes: 10mL, 50mL, 1000mL
    • Reagent agnostic (all vendors supported)
    • Refrigerated at 4°C
    • Just in time lane for time critical reagent delivery
    • Integrated software for reagent scheduling, inventory and supply chain management
    • All SLTDs undergo ionized hydrogen peroxide decontamination cycles

    QC - Automated Sampling & Online Analysis

    • Automated sample collection
    • Online analysis: integrated cell culture analyzer supports 16 assays including cell count and viability
    • Offline analysis: sample containers can be collected from the Cell Shuttle
    • Real-time process monitoring
    • Auto-generated electronic batch records

    QC - Automated Sampling & Online Analysis

    • Automated sample collection
    • Online analysis: integrated cell culture analyzer supports 16 assays including cell count and viability
    • Offline analysis: sample containers can be collected from the Cell Shuttle
    • Real-time process monitoring
    • Auto-generated electronic batch records

    4x Sterile Liquid Transfer Systems (SLTS)

    • Facilitates mating of Cellares’ Consumable Cartridge and automation friendly reagent bottles (SLTDs)
    • Performs all sterile liquid transfer operations including reagent addition and sampling

    4x Sterile Liquid Transfer Systems (SLTS)

    • Facilitates mating of Cellares’ Consumable Cartridge and automation friendly reagent bottles (SLTDs)
    • Performs all sterile liquid transfer operations including reagent addition and sampling

    Material Handling System (MHS)

    • Automates the transfer of Consumable Cartridges (CC) and automation-friendly reagent bottles (SLTDs)
    • Transfers occur between feedthroughs, reagent vault system (RVS) and instruments (BPS and SLTS)

    Material Handling System (MHS)

    • Automates the transfer of Consumable Cartridges (CC) and automation-friendly reagent bottles (SLTDs)
    • Transfers occur between feedthroughs, reagent vault system (RVS) and instruments (BPS and SLTS)

    16x Bioprocessing Systems (BPS)

    • Counterflow Centrifugal Elutriation (CCE)
    • Magnetic Selection (MS)
    • Electroporation (EP)
    • Bioreactor System (BRS)

    16x Bioprocessing Systems (BPS)

    • Counterflow Centrifugal Elutriation (CCE)
    • Magnetic Selection (MS)
    • Electroporation (EP)
    • Bioreactor System (BRS)

    Integrated and Flexible Software Suite

    • Process Design Studio supports 90% of cell therapy modalities (auto & allo) in a single cartridge design
    • Integrated MES allows for batch scheduling across Cell Shuttle fleet
    • Real-time process monitoring solution
    • Auto-generation of electronic batch records
    • Integrates with 3rd party software systems (ERP, MES, LIMS)

    Integrated and Flexible Software Suite

    • Process Design Studio supports 90% of cell therapy modalities (auto & allo) in a single cartridge design
    • Integrated MES allows for batch scheduling across Cell Shuttle fleet
    • Real-time process monitoring solution
    • Auto-generation of electronic batch records
    • Integrates with 3rd party software systems (ERP, MES, LIMS)

    Cell Shuttle Feedthrough

    • Up to 16 cartridges can be loaded asynchronously for multi-product, concurrent manufacturing
    • Each cartridge can run a different cell therapy process as defined in the Process Design Studio
    • Each cartridge can produce a different batch/product
    • The feedthrough is the entry and exit point for all Consumable Cartridges
    • All cartridges undergo ionized hydrogen peroxide decontamination cycles

    Cell Shuttle Feedthrough

    • Up to 16 cartridges can be loaded asynchronously for multi-product, concurrent manufacturing
    • Each cartridge can run a different cell therapy process as defined in the Process Design Studio
    • Each cartridge can produce a different batch/product
    • The feedthrough is the entry and exit point for all Consumable Cartridges
    • All cartridges undergo ionized hydrogen peroxide decontamination cycles

    Cell Shuttle Sterility Paradigm

    • Each batch/product has a dedicated set of pre-sterilized automation-friendly reagent bottles (SLTDs) and one Consumable Cartridge. Each set which constitutes a closed system
    • The Cell Shuttle maintains an internal ISO8 cleanroom environment
    • The Cell Shuttle can be deployed in controlled not-classified environments (CNC)
    • All consumables undergo ionized hydrogen peroxide decontamination cycles as they enter the feedthrough or the reagent vault system (RVS)

    Cell Shuttle Sterility Paradigm

    • Each batch/product has a dedicated set of pre-sterilized automation-friendly reagent bottles (SLTDs) and one Consumable Cartridge. Each set which constitutes a closed system
    • The Cell Shuttle maintains an internal ISO8 cleanroom environment
    • The Cell Shuttle can be deployed in controlled not-classified environments (CNC)
    • All consumables undergo ionized hydrogen peroxide decontamination cycles as they enter the feedthrough or the reagent vault system (RVS)

    Rapid Access Hatches

    • Used to add time-sensitive materials such as viral vector
    • Facilitates retrieval of in-process samples for analysis

    Rapid Access Hatches

    • Used to add time-sensitive materials such as viral vector
    • Facilitates retrieval of in-process samples for analysis
    • 16 batches processed in parallel
    • 75% fewer process failures
    • 90% less labor required
    • 90% less facility space required
    • The majority of modalities supported (auto & allo)
    “Cellares’ revolutionary technology will be a game changer for the cell therapy industry.“
    PROF. CARL JUNE, MD
    CAR-T Cell Therapy Pioneer,
    Cellares Advisory Board Member
    INTEGRATED AUTOMATION

    Truly Closed and Automated from End-To-End

    Electroporators (EP)

    • Achieves world-class EP efficiency
    • All EP parameters are customizable via Process Design Suite which enables EP optimization
    • Supports all common genetic modification technologies (CRISPR, TALEN, ZFN) and reagents
    • Ability to electroporate infinite number of cells via automated batch processing

    Electroporators (EP)

    • Achieves world-class EP efficiency
    • All EP parameters are customizable via Process Design Suite which enables EP optimization
    • Supports all common genetic modification technologies (CRISPR, TALEN, ZFN) and reagents
    • Ability to electroporate infinite number of cells via automated batch processing
    Supported Unit Operations
    • TRANSFECTION

    Peristaltic Pumps

    • Multiple peristaltic pumps enable multiple process steps to run in parallel on the same cartridge
    • Pump interfaces are used to facilitate sterile, metered liquid transfer between internal cartridge modules and automation friendly reagent bottles (SLTDs)

    Peristaltic Pumps

    • Multiple peristaltic pumps enable multiple process steps to run in parallel on the same cartridge
    • Pump interfaces are used to facilitate sterile, metered liquid transfer between internal cartridge modules and automation friendly reagent bottles (SLTDs)
    Supported Unit Operations
    • ENRICHMENT
    • BUFFER EXCHANGE
    • CONCENTRATION
    • SAMPLING
    • IN-PROCESS QC
    • SELECTION
    • ACTIVATION
    • TRANSDUCTION
    • TRANSFECTION
    • EXPANSION
    • FORMULATION

    Fluidic Bus

    • Integrated valves, sensors, fluid channels, and pumps automate all internal fluid transfers
    • The Fluidic Bus enables reagent transfers from any module of the cartridge to any other module
    • The modularity of the Fluidic Bus enables support for the majority of cell therapy modalities (auto & allo) within the same cartridge design

    Fluidic Bus

    • Integrated valves, sensors, fluid channels, and pumps automate all internal fluid transfers
    • The Fluidic Bus enables reagent transfers from any module of the cartridge to any other module
    • The modularity of the Fluidic Bus enables support for the majority of cell therapy modalities (auto & allo) within the same cartridge design
    Supported Unit Operations
    • ENRICHMENT
    • BUFFER EXCHANGE
    • CONCENTRATION
    • SAMPLING
    • IN-PROCESS QC
    • SELECTION
    • ACTIVATION
    • TRANSDUCTION
    • TRANSFECTION
    • EXPANSION
    • FORMULATION

    Reagent & Final Product Containers

    • Smart containers provide precise, real-time volume tracking
    • Integrated smart containers for starting material, reagent storage and final product formulation

    Reagent & Final Product Containers

    • Smart containers provide precise, real-time volume tracking
    • Integrated smart containers for starting material, reagent storage and final product formulation
    Supported Unit Operations
    • ENRICHMENT
    • BUFFER EXCHANGE
    • CONCENTRATION
    • SELECTION
    • ACTIVATION
    • TRANSDUCTION
    • TRANSFECTION
    • EXPANSION
    • FORMULATION

    Bioreactor System (BRS)

    • Supports expansion of >20 billion cells
    • Perfusion-enabled stirred-tank design
    • Closed loop control and real-time monitoring of temperature (T), dissolved oxygen, (DO) and acidity (pH)

    Bioreactor System (BRS)

    • Supports expansion of >20 billion cells
    • Perfusion-enabled stirred-tank design
    • Closed loop control and real-time monitoring of temperature (T), dissolved oxygen, (DO) and acidity (pH)
    Supported Unit Operations
    • ACTIVATION
    • TRANSDUCTION
    • EXPANSION

    Sterile Liquid Transfer Ports (SLTP)

    • Supports reagent additions, waste removal and automated sampling
    • SLTPs on the Consumable Cartridge (CC) interface with the SLTPs on the automation-friendly reagent bottles (SLTDs)
    • The Sterile Liquid Transfer System (SLTS) facilitates metered, automated, sterile liquid transfer into and out of the Consumable Cartridge

    Sterile Liquid Transfer Ports (SLTP)

    • Supports reagent additions, waste removal and automated sampling
    • SLTPs on the Consumable Cartridge (CC) interface with the SLTPs on the automation-friendly reagent bottles (SLTDs)
    • The Sterile Liquid Transfer System (SLTS) facilitates metered, automated, sterile liquid transfer into and out of the Consumable Cartridge
    Supported Unit Operations
    • ENRICHMENT
    • BUFFER EXCHANGE
    • CONCENTRATION
    • SAMPLING
    • IN-PROCESS QC
    • SELECTION
    • ACTIVATION
    • TRANSDUCTION
    • TRANSFECTION
    • EXPANSION
    • FORMULATION

    Magnetic Cell Sorter (MS)

    • Supports magnetic selection with both microbeads and nanobeads (reagent agnostic)
    • Supports both positive and negative selection
    • Column-free design operates in batch mode to process any volume of cells

    Magnetic Cell Sorter (MS)

    • Supports magnetic selection with both microbeads and nanobeads (reagent agnostic)
    • Supports both positive and negative selection
    • Column-free design operates in batch mode to process any volume of cells
    Supported Unit Operations
    • SELECTION

    Counterflow Centrifugal Elutriator (CCE)

    • Operates in batch mode to process any volume of cells
    • Can be used at arbitrary times in the workflow as defined in the Process Design Studio

    Counterflow Centrifugal Elutriator (CCE)

    • Operates in batch mode to process any volume of cells
    • Can be used at arbitrary times in the workflow as defined in the Process Design Studio
    Supported Unit Operations
    • ENRICHMENT
    • BUFFER EXCHANGE
    • CONCENTRATION
    • FORMULATION

    The integrated Consumable Cartridge reduces process failure rates by 75%

    • Automation eliminates opportunities for operator error
    • Closing the process eliminates opportunities for contamination

    • ENRICHMENT

    • BUFFER EXCHANGE

    • CONCENTRATION

    • SAMPLING

    • IN-PROCESS QC

    • SELECTION

    • ACTIVATION

    • TRANSDUCTION

    • TRANSFECTION

    • EXPANSION

    • FORMULATION

    “The Cell Shuttle is a quantum leap forward as there is nothing similar in the cell therapy industry. The Cell Shuttle is the first real end-to-end, high-throughput manufacturing solution. It’s not truly end-to-end unless it’s integrated like the Cell Shuttle."
    TimothyMoore
    TIMOTHY MOORE
    CTO, Allogene Therapeutics,
    Cellares Advisory Board Member
    SCALABILITY

    Enabling Commercial Scale Manufacturing of Cell Therapies

    • Integrated Automation

      All unit operations in one Consumable Cartridge

    • High Throughput

      Up to 16 cartridges for multi-product, concurrent manufacturing

    • Scalability 

      Up to 2,800 batches per Cell Shuttle per year

    Cost Savings

    50% Reduction in Average Manufacturing Costs

    LEARN MORE

    Fully Automated, Scalable, cGMP Cell Therapy QC Platform

    High Throughput QC

    Integrates & Automates Off-the-Shelf, Industry Standard QC Instrumentation

    Modular Instrument Carts

    • Integrates industry standard, off-the-shelf QC instrumentation to automate the vast majority of in-process and release assays
    • Allows for interchange of instrumentation enabling customized workflows
    • Minimizes workcell downtime by providing rapid replacement of pre-qualified instruments

    Modular Instrument Carts

    • Integrates industry standard, off-the-shelf QC instrumentation to automate the vast majority of in-process and release assays
    • Allows for interchange of instrumentation enabling customized workflows
    • Minimizes workcell downtime by providing rapid replacement of pre-qualified instruments

    Fully Integrated IDMO Data Stack

    • Supports auto-generation of electronic batch records (EBRs)
    • Enables real-time manufacturing process monitoring

    Fully Integrated IDMO Data Stack

    • Supports auto-generation of electronic batch records (EBRs)
    • Enables real-time manufacturing process monitoring

    Feedthrough

    • Entry point for all samples either in SLTD format or standard cryotubes
    • Can process multiple samples from multiple batches concurrently
    • Barcode scanning of all samples and reagents ensures maintenance of chain of identity and chain of custody

    Feedthrough

    • Entry point for all samples either in SLTD format or standard cryotubes
    • Can process multiple samples from multiple batches concurrently
    • Barcode scanning of all samples and reagents ensures maintenance of chain of identity and chain of custody

    Cell Q Workcell

    • Fully enclosed, cGMP QC workcell maintains sample sterility
    • Hatches provide easy access for consumable and reagent addition as well as waste removal

    Cell Q Workcell

    • Fully enclosed, cGMP QC workcell maintains sample sterility
    • Hatches provide easy access for consumable and reagent addition as well as waste removal

    Integrated Liquid and Plate Handlers

    • Liquid and plate handlers transfer samples and reagents between assay plates and instruments
    • Automated sample handling improves reliability and reproducibility of assays via liquid volume detection and other feedback mechanisms

    Integrated Liquid and Plate Handlers

    • Liquid and plate handlers transfer samples and reagents between assay plates and instruments
    • Automated sample handling improves reliability and reproducibility of assays via liquid volume detection and other feedback mechanisms
    • Up to 6,000 batches per year
    • Enables up to 50% lower price per batch
    • Automates the majority of cell therapy QC assays
    • Auto-generates electronic batch records
    • Pre-qualified assays accelerate analytical transfer
    UNCAPPED CAPACITY

    High-Throughput Manufacturing Requires High-Throughput QC

    Automated High-Throughput Manufacturing
    Cell Shuttles
    Samples transferred via SLTDs*
    Cell Q
    Automated High-Throughput QC
    *Automation-friendly reagent bottles
    FLEXIBLE SOFTWARE

    Integrated Software Suite Supports the Majority of Cell Therapy Modalities

    • SUPPORTED APPLICATIONS

      • Autologous & Allogeneic
      • CAR-T, TCR, HSC, NK, TIL, Treg, γδ T cells

    • FLEXIBLE SOFTWARE

      • Process customization via Process Design Studio
      • Enables digital process development and DOE

    • INTEGRATED HARDWARE

      • Every process uses the same modular Consumable Cartridge
      • No hardware customization required, which accelerates technology adoption
    IDMO ADVANTAGE

    Software & Hardware Integration Enable
the IDMO Advantage

    • ERP
    • Cell Shuttle
    • Cell Q
    • QC LIMS
    • Electronic Batch Records
    • Scalability
      Meet Total Patient Demand Globally with Unconstrained Capacity
    • Cost Savings
      Up to 50% Reduction in Batch Prices
    • Speed
      Up to 50% Faster to IND & BLA and Accelerated Global Reach