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Unlock the Full Potential of Your Cell Therapy

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    The First Integrated Development & Manufacturing Organization

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    • 118,000 ft²

      Smart Factory space

    • >40k

      Capacity in batches per year
      (based on a 7 day autologous process)

    • Only 6 months

      Time to tech transfer
    “Mass manufacturing personalized living drugs needs a totally new approach.”
    PROF. CARL JUNE, MD
    CAR-T Cell Therapy Pioneer,
    Cellares Advisory Board Member
    CMO CDMO IDMO

    IDMOs Overcome the Limitations of Conventional CDMOs

    VERTICAL INTEGRATION
    • Technology & Services
    • Smart Factories
    • Mass Customization
    TECHNOLOGY INTEGRATION
    • Hardware Integration
    • Software Integration
    • Data Integration

    Integrated Development and Manufacturing Organizations (IDMOs) offer highly integrated and advanced technologies as the key element of a vertically integrated business model, which includes global manufacturing services.

    By leveraging integrated technologies, IDMO Smart Factories can produce 10 times more cell therapy batches per year, with the same footprint and the same workforce as conventional CDMO facilities.

    Cellares’ Smart Factories will be deployed around the world to enable the cell therapy industry to meet global patient demand.

    IDMOs leverage hardware standardization, Software-Defined Manufacturing (SDM), and a high degree of automation to enable mass customization. This is a key capability for the mass manufacturing of personalized cell therapies.

    As SOPs (Standard Operating Procedures) are replaced with SDM (Software-Defined Manufacturing), tech transfer is dramatically simplified and training requirements are reduced.

    The cGMP Cell Shuttle platform integrates technologies for all unit operations in a fully closed, automated and high-throughput system. It’s functionally equivalent to ~100 benchtop instruments.

    Software-defined manufacturing (SDM) and hardware standardization enable instant tech transfer from one Cell Shuttle to any other Cell Shuttle in any other Smart Factory anywhere in the world.

    IDMOs seamlessly interconnect software systems (MES, LIMS, ERP, QMS) with the integrated hardware for manufacturing and QC to create an integrated data stack.

    Data integration enables auto-generation of electronic batch records (EBRs), supply chain management, and big data mining applications.

    VERTICAL INTEGRATION
    • Technology & Services
    • Smart Factories
    • Mass Customization
    TECHNOLOGY INTEGRATION
    • Hardware Integration
    • Software Integration
    • Data Integration
    “The therapeutic industry needs a scalable and cost-effective system to remain competitive and to grow operations for patients. The Cell Shuttle is the integrated development and manufacturing solution that will make this happen.”
    TimothyMoore
    TIMOTHY MOORE
    CTO, Allogene Therapeutics,
    Cellares Advisory Board Member
    Capabilities

    IDMO Services

    • Technology Adoption Program (TAP)

      TAP is a fast and low-risk opportunity to automate and transfer your process onto the Cell Shuttle

      Learn about TAP

    • Cell Therapy Process Development (PD)

      Utilize Cellares IDMO to optimize and automate your cell therapy process. Leverage the standardized Cell Shuttle templates to accelerate PD for early-stage processes

    • Analytical Development (AD)

      Utilize Cellares’ automated and integrated analytical platform for reliable in-process and final product characterization

    • Clinical & Commercial cGMP Manufacturing

      Utilize Cellares global network of IDMO Smart Factories to address total patient demand across all drug development and commercialization phases

    • Quality Assurance / Quality Control Services

      World-class Quality organization with decades of combined cell therapy experience that provides products meeting global cGMP requirements with the highest level of quality

    • Regulatory Support

      Regulatory experts support CMC data package generation for successful regulatory filings and amendments

    IDMO ADVANTAGE

    Choosing Cellares Means Choosing the IDMO Advantage

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    EXPERTISE

    Choose a Team You Can Trust

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    • JohnTomtishen
      John Tomtishen
      Vice President, Operations & IDMO General Manager
      John is a cell therapy industry veteran having played pivotal roles in the filing and approval of the first CAR-T therapy, Kymriah™, while serving at Novartis, and the clinical development and BLA filing of Carvykti™ while at Legend Biotech.

      At Cellares, John oversees Cellares' IDMO business, supports partnership activities, and is facilitating Cell Shuttle market adoption.
      Director, Manufacturing & Tech Ops, Legend Biotech
      MSAT, CGTDM Tech Ops, Novartis
    • EricFulmer
      Eric Fulmer
      Vice President, Quality
      Eric has over 25 years of experience building phase-appropriate Quality Organizations at Drug Discovery and CDMO companies. He has hosted inspections from several inspectorates, including FDA, EMA, PMDA, and ANVISA for new drugs applications, post approval submissions, and routine surveillance.

      At Cellares, Eric is leading the Quality Control, Quality Assurance, Validation, and Regulatory Affairs teams in implementing a scalable, compliant, and Phase-Appropriate Quality Management System to meet Global Regulations and Expectations.
      VP of Quality and Compliance, Bionova Scientific
      Team Leader, Drug Substance Quality Assurance, Samsung Biologics
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    Our Smart Factories

    Smart Factories by the Numbers

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    • Factory_SouthSanFranciscoCA
      South San Francisco (CA) Preclinical & Clinical Services / Technology Development
      • 57,000 ft²
      • cGMP-ready in H1/2024
      • 2 Cell Shuttles (capacity)
      • 1,600 patient doses per year (based on a 7 day process)
    • Factory_BridgewaterNJ
      Bridgewater (NJ) Preclinical, Clinical & Commercial Services
      • 118,000 ft²
      • cGMP-ready in H2/2024
      • 50 Cell Shuttles (capacity)
      • 40,000 patient doses per year (based on a 7 day process)