PARTNERING

Unlock the Full Potential of Your Cell Therapy

Join the IDMO Revolution

Clinical & Commercial cGMP Manufacturing

  • TRANSLATE YOUR PROCESS INTO THE IDMO ECOSYSTEM

    Transfer and automate your existing CAR-T process into the Cellares IDMO ecosystem in as few as 12 months

  • LEVERAGE CELLARES' STANDARD CAR-T PROCESS

    Manufacture cGMP product using our pre-optimized, fully-automated, turnkey CAR-T process including analytics, in as few as 8 months

Additional Services
  • PROCESS & ANALYTICAL DEVELOPMENT

    Develop, optimize, and automate your cell therapy process utilizing Cellares' manufacturing and quality control technologies

  • GLOBALIZATION PACKAGE

    Using the Cellares global network of IDMO Smart Factories, rapidly expand into new markets via functionally instantaneous tech transfers

  • REGULATORY SUPPORT

    Access our regulatory experts to support the generation and submission of CMC data packages

Working with the Cellares IDMO

Leverage Automated Technologies to Accelerate Your Pathway to cGMP Manufacturing

Tech Translation & Feasibility

  • Transfer your process and analytical assay knowledge
  • Generate and execute the unit operation and analytical plan
  • Execute automated manufacturing run & generate draft batch record

cGMP Bridging

  • Technology transfer to cGMP laboratory & method qualification
  • Engineering/comparability runs, QC test & release, and stability study initiation
  • Finalize manufacturing and QC SOPs, CPPs, and CQAs
  • Process characterization/validation & regulatory support

Clinical & Commercial cGMP Manufacturing

  • Generate manufacturing plan and production forecast
  • Produce cGMP cell therapy batches
  • Final drug product QC and release

Translate and Automate Your Process or Leverage the Cellares Standard CAR-T Process

  • Advantages of Translating Your Process Into the IDMO Ecosystem
    • Get to IND and BLA up to 33% faster* and accelerate global expansion
    • Single technology platform that scales seamlessly as your asset progresses through development
    • Up to a 50% reduction in batch price*
    *Compared to conventional CDMOs
  • Advantages of Using the Cellares Standard CAR-T Process
    • Get to IND and BLA up to 50% faster* and accelerate global expansion
    • Includes pre-qualified analytics
    • Up to a 50% reduction in batch price*
    • Frees you to focus resources on the biology & clinical success of your asset rather than process development & manufacturing
    *Compared to conventional CDMOs
Translation time dependent on process complexity

Rapidly Expand Your Cell Therapy to New Markets Leveraging the Global Network of Cellares IDMO Smart Factories

  • Speed Functionally instantaneous tech transfer to additional manufacturing sites in the US, Europe and Japan
  • Scalability Accelerate your ability to meet the total global patient demand
  • Cost savings De-risk regional expansion by leveraging Cellares' global regulatory expertise

Flexible IDMO Service Models

All facilities are built and operated by Cellares using our proprietary Equipment
Shared Model
Hybrid Model
Dedicated Model
Smart Factory
Shared
Shared
Dedicated
Equipment (Cell Shuttles & Cell Qs)
Shared
Dedicated
Dedicated
Service Model Phase Guidance
Phase I-III
Phase II-Commercialization
Commercialization
Suite Fees
None
None
None
Shared facilities and equipment are recommended for developers that require increased flexibility with regards to cell therapy volumes needed and timing. Dedicated facilities and equipment are a high-volume solution that guarantees immediate manufacturing capacity and are recommended for developers translating commercial-phase assets.

Cellares is Working with 5 out of 8 of the World's Largest Pharmaceutical Companies In Cell Therapy

Publicly disclosed partners include:
  • Bristol Myers Squibb
    • Bristol Myers Squibb and Cellares have signed a global capacity reservation and supply agreement for the manufacture of cell therapies in a transaction valued up to $380M
    • Cellares is providing proof-of-concept manufacturing for two Bristol Myers Squibb CAR-T cell therapies
  • Cabaletta Bio
    • Cellares and Cabaletta Bio have partnered to validate Cellares’ Cell Shuttle platform for the manufacture of Cabaletta's CABA-201 cell therapy
    • CABA-201, Cabaletta Bio’s fully human CD19-CAR T product candidate, is being evaluated in parallel phase 1/2 trials across multiple autoimmune diseases
  • Lyell
    • Cellares and Lyell have partnered for proof-of-concept automated manufacture of a key Lyell CAR T-cell therapy using Cellares’ Cell Shuttle
    • This collaboration will evaluate potential utilization of the Cell Shuttle for future Lyell CAR T-cell clinical trials and commercialization
Among other leading Pharmaceutical and Biotechnology Companies.