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Fully Integrated, Scalable, cGMP Cell Therapy Manufacturing Platform

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HIGH THROUGHPUT MANUFACTURING

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 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 hydrogen peroxide decontamination cycles

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 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 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 of these consumable sets 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 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 of these consumable sets 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 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

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

Up to 50% reduction in cost per batch

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