CellBuilder™
Expanding Access to Potentially Life-Saving Cell and Gene Therapies
CellBuilder™ is a turnkey solution developed by the Cellular Therapy Laboratory at Children’s National Hospital to help academic centers and hospitals establish or expand cell and gene therapy programs efficiently, safely and cost-effectively.
Built on Children’s National’s extensive experience in GMP manufacturing, clinical trial support, regulatory submissions, quality systems, and multicenter cell therapy clinical trial implementation, CellBuilder™ provides the infrastructure, tools, training and advisory support needed to accelerate program development and bring advanced therapies closer to patients.
Programs and Services
CellBuilder™ offers customizable modules and services based on each institution’s needs, including:
Cell Therapy Program Modules
- Virus-specific T cells
- Tumor-associated antigen specific T cells
- CAR T cells
- Mesenchymal stromal cells
- Hematopoietic stem cell cryopreservation
Services Offered
- Non-exclusive licensing of existing technologies of interest including associated protocols, SOPs, templates and related program materials
- Facility and infrastructure assessment
- GMP advisory services
- Manufacturing process technology transfer
- Hands-on and virtual training for manufacturing, QA/QC and program leadership teams
- Regulatory and clinical research support, including IND/CMC preparation, protocol development, responses to FDA queries and annual reporting support
- Review of critical SOPs, protocols, training materials and manufacturing data
Why CellBuilder™
CellBuilder™ is designed to help institutions reduce the time, cost, and risk associated with building cell and gene therapy capabilities. By leveraging established experience, proven workflows, and practical implementation support, CellBuilder™ enables programs to treat patients locally, strengthen institutional clinical trial infrastructure, and support future development of novel therapies.
Contact Us
To learn more about CellBuilder™ or discuss potential collaboration, please contact us.