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
IDMOs Overcome the Limitations of Conventional CDMOs
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Technology & Services -
Smart Factories
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Mass Customization
Technology & Services 
Smart Factories 
Mass Customization -
Hardware Integration
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Software Integration
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Data 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.
IDMO Services
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Technology Adoption Program (TAP)
TAP is a fast and low-risk opportunity to automate and transfer your process onto the Cell Shuttle
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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
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Analytical Development (AD)
Utilize Cellares’ automated and integrated analytical platform for reliable in-process and final product characterization
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Clinical & Commercial cGMP Manufacturing
Utilize Cellares global network of IDMO Smart Factories to address total patient demand across all drug development and commercialization phases
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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
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Regulatory Support
Regulatory experts support CMC data package generation for successful regulatory filings and amendments
Technology Adoption Program (TAP) 
Cell Therapy Process Development (PD) 
Analytical Development (AD) 
Clinical & Commercial cGMP Manufacturing 
Quality Assurance / Quality Control Services 
Regulatory Support Clinical and Commercial Cell Therapy Manufacturing
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Cellares Standard CAR-T Process
Pre-optimized, fully-automated, Plug-and-Play CAR-T manufacturing process including pre-qualified analytics. As few as 8 months to cGMP manufacture.
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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.
Additional Services
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Globalization Package
Rapidly expand your cell therapy to new markets leveraging the global network of Cellares IDMO Smart Factories
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Process & Analytical Development
Utilize Cellares automated cell therapy manufacturing and quality control technologies to optimize and automate your cell therapy process.
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Regulatory Support
Regulatory experts support CMC data package generation for successful regulatory filings and amendments
Unlimited Capacity 
Cost Savings 
Quality 
Speed 
Flexibility -
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 -
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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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)
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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)
