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:

  • Faster treatment delivery for urgent or relapsed cases

  • Lower costs per dose by leveraging hospital-based GMP

  • Sovereignty in production, ensuring long-term capability

  • 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

  • GMP facility consulting and cleanroom layout

  • Workflow design for closed or semi-open CAR-T processes

  • Equipment selection and commissioning support

2️⃣ SOP Development & QA System Setup

  • Process-specific SOPs, forms, and batch records

  • Quality management system (QMS) templates and training

  • Regulatory compliance for Chinese NMPA and international standards

3️⃣ On-Site Training & Hands-On Execution

  • Operator training for production, QC, and QA staff

  • Trial batches and validation runs with our team support

  • Troubleshooting, documentation, and deviation handling

4️⃣ Optional: Access to Validated CAR-T Constructs

  • Multiple options available through our trusted technology partners

  • Ready-to-use protocols and reagents

  • 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:

  • Enable facility setup and process implementation in under 6 months

  • Train multi-disciplinary teams — from production to QA/QC

  • 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.