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Clinical & Commercial cGMP Manufacturing
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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 
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                                             LEVERAGE CELLARES' STANDARD CAR-T PROCESS LEVERAGE CELLARES' STANDARD CAR-T PROCESSManufacture cGMP product using our pre-optimized, fully-automated, turnkey CAR-T process including analytics, in as few as 8 months 
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                                             PROCESS & ANALYTICAL DEVELOPMENT PROCESS & ANALYTICAL DEVELOPMENTDevelop, optimize, and automate your cell therapy process utilizing Cellares' manufacturing and quality control technologies 
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                                             GLOBALIZATION PACKAGE GLOBALIZATION PACKAGEUsing the Cellares global network of IDMO Smart Factories, rapidly expand into new markets via functionally instantaneous tech transfers 
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                                            REGULATORY SUPPORT Access our regulatory experts to support the generation and submission of CMC data packages 
Working with the Cellares IDMO
 
   
                        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
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                                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
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                                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
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
 
                            Cellares is Working with 5 out of 8 of the World's Largest Pharmaceutical Companies In Cell Therapy
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                                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
 
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                                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
 
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                                 Lyell 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
 
 
                                    
                 LEVERAGE CELLARES' STANDARD CAR-T PROCESS
                                                LEVERAGE CELLARES' STANDARD CAR-T PROCESS                                             PROCESS & ANALYTICAL DEVELOPMENT
                                                PROCESS & ANALYTICAL DEVELOPMENT                                             GLOBALIZATION PACKAGE
                                                GLOBALIZATION PACKAGE                                            