Cell and Gene Therapy (CGT) Orchestration Platform

The Cell and Gene Therapy (CGT) Orchestration Platform from Title21 Health Solutions is a software platform designed to replace paper-based and fragmented digital workflows in cell and gene therapy manufacturing. It targets CAR-T and biotherapeutic manufacturers, CDMOs, cellular therapy laboratories, blood centers, biobanks, and blood and marrow transplant programs that need to consolidate documentation, quality management, and regulatory compliance into a single system.

Title21's platform addresses the operational challenges that arise when manufacturing teams rely on a mix of paper records and disconnected software tools. By centralizing process documentation and quality workflows, the platform aims to reduce administrative burden, improve traceability, and support faster patient delivery of cell and gene therapies.

Manufacturing Efficiency and Scalability

• Consolidates documentation across all stages of manufacturing into a single location, removing data silos created by paper-based and patchwork software approaches.
• Supports electronic batch records, sample tracking, inventory management, equipment management, environmental monitoring, cleanroom cleaning and testing records, and device integration through its Manufacturing Execution System (MES) module.
• Reduces reliance on hard copy manuals; one documented case study reports an 82% decrease in hard copy manuals after implementing electronic versions.
• Reported outcomes from real-world use include 13 hours per week of departmental staff time reallocated to operational duties, 19 hours per week saved in document version control management, and 208 days saved per year in employee time previously spent managing hard copy manuals.

Regulatory Compliance

• Designed to support compliance with stringent and evolving cell and gene therapy regulations, including FDA 21 CFR Part 11 requirements for electronic records and signatures.
• Provides thorough documentation of every process step to support safety, efficacy, and traceability requirements.
• Includes an Enterprise Quality Management System (EQMS) module with integrated, configurable quality system components.
• Has been reported by users to withstand external regulatory reviews.
• Supports accreditation compliance alongside regulatory standards throughout manufacturing operations.

Time-to-Patient Delivery

• Provides complete visibility into the manufacturing process to help identify and resolve bottlenecks that slow patient delivery.
• Supports data-driven decision-making and proactive problem-solving by surfacing real-time process data.
• Addresses supply chain disruptions and cost inflation associated with paper-based workflows that can delay treatment delivery.

Platform Modules and Solutions

• CGT Orchestration Platform — core orchestration layer for cell and gene therapy workflows.
• Manufacturing Execution System (MES) — covers electronic batch records, environmental monitoring, sample tracking, inventory and equipment management, cleanroom processes, and device integration.
• Enterprise Quality Management System (EQMS) — integrated quality and document management.
• Blood and Marrow Transplant (BMT) — dedicated module for standard of care and transplant programs.
• GMP Facilities Services — support for GMP-compliant facility operations.

Title21 Health Solutions has expanded its digital capabilities through the acquisition of MyCellHub. The platform is used by organizations including the University of Minnesota, Miller-Keystone Blood Center, and Cleveland Cord Blood Center, and is positioned for deployment across a range of life sciences settings requiring GMP-compliant, FDA-regulated manufacturing documentation and quality management.