Title21 Health Solutions offers an Electronic Batch Record and Quality Management System tailored for blood and marrow transplant processes, digitizing operations such as ISBT 128 labeling and inventory management. This platform enhances compliance and operational efficiency, addressing the inefficiencies and risks associated with paper-based workflows in complex biomanufacturing environments.
Funding
Funding not disclosed
Founders
Product
Problem
Cell and gene therapies face challenges due to reliance on manual processes, leading to inefficiencies, higher costs, increased error risks, and delayed patient treatment. Disjointed systems and data silos further hinder real-time visibility and streamlined operations.
Solution
Title21 Health Solutions offers a Cell and Gene Therapy (CGT) Orchestration Platform that streamlines documentation and quality processes, enabling biomanufacturing facilities to focus on delivering life-saving treatments. The platform provides easy-to-follow workflows, data-driven insights, and enhanced interoperability, breaking down data silos and providing a 360-degree view of the manufacturing process. By automating and optimizing processes, the platform enhances efficiency, reduces errors, ensures regulatory compliance, and accelerates therapy delivery to patients.
Target Audience
The primary customers are blood and marrow transplant centers, CAR-T and biotherapeutic manufacturers, and cellular therapy laboratories seeking to streamline operations, ensure regulatory compliance, and improve patient outcomes.
Features
- Integrated Electronic Batch Records (EBR) to ensure product safety, efficacy, and traceability
- Streamlined data management tools for standard of care transplant program workflows, from patient evaluation to product infusion and long-term follow-up
- Automated staff training and learning, and SOP documentation lifecycle management
- Real-time visibility into every stage of the manufacturing process, enabling early issue detection and risk mitigation
- Integration with existing systems, devices, suppliers, partners, and registries to reduce data entry time and eliminate redundancy
- Role-based access controls based on personnel training and certifications
- Tools to support compliance with FACT/JACIE, AABB, GxP, HIPAA, and 21 CFR Part 11 requirements