Decentralized PoC CAR-T Manufacture
Investigator Initiated Trial Service for Cell and Gene Therapy
Build Your In-House CAR-T Capability — From Concept to Clinic
At Cytoart, Inc., we empower hospitals and research institutions to establish their own CAR-T manufacturing platforms — enabling local, agile, and sustainable delivery of cell therapies.
Through our PoC (Proof-of-Concept) Decentralized Manufacturing Program, we help you build a fit-for-purpose CAR-T production system from the ground up — combining regulatory-aligned process design, hands-on training, and optional access to clinically validated CAR-T constructs.
Why Decentralized Manufacturing?
Decentralized CAR-T manufacturing brings life-saving therapies closer to patients, while reducing reliance on centralized CDMOs and long supply chains. Our solution supports:
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Faster treatment delivery for urgent or relapsed cases
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Lower costs per dose by leveraging hospital-based GMP
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Sovereignty in production, ensuring long-term capability
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Adaptability for future targets, constructs, or indications
Whether you’re a regional cancer hospital, a translational research hub, or a national precision medicine center — we tailor a solution to match your ambitions.
What We Offer
1️⃣ Facility Planning & Process Design
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GMP facility consulting and cleanroom layout
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Workflow design for closed or semi-open CAR-T processes
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Equipment selection and commissioning support
2️⃣ SOP Development & QA System Setup
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Process-specific SOPs, forms, and batch records
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Quality management system (QMS) templates and training
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Regulatory compliance for Chinese NMPA and international standards
3️⃣ On-Site Training & Hands-On Execution
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Operator training for production, QC, and QA staff
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Trial batches and validation runs with our team support
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Troubleshooting, documentation, and deviation handling
4️⃣ Optional: Access to Validated CAR-T Constructs
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Multiple options available through our trusted technology partners
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Ready-to-use protocols and reagents
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Ideal for hospital-led IITs or first-in-human PoC studies
We offer flexibility: bring your own construct, or partner with us to launch clinical-grade CAR-T trials using proven, validated systems.
Ready to Support Hospital-Based CAR-T Programs
At Cytoart, we are actively working with hospitals and institutions across Asia and the Middle East to plan and initiate decentralized CAR-T manufacturing programs. Our platform is designed to:
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Enable facility setup and process implementation in under 6 months
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Train multi-disciplinary teams — from production to QA/QC
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Accommodate diverse constructs, including solid tumor, dual-targeting, or investigator-originated designs
While each hospital’s needs are unique, our approach is flexible and scalable — built to adapt to your clinical indication, technology stack, and local infrastructure.
Let’s Build Together
If you’re ready to bring CAR-T manufacturing in-house — or simply want to explore feasibility — Cytoart is your partner from zero to first patient.
Contact us to request a discovery call or a tailored proposal for your site.