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Company description

Title21 Health Solutions develops software for cell and gene therapy manufacturing, quality management, and clinical operations. The company serves a range of life sciences organizations including blood centers and biobanks, CAR-T and biotherapeutic manufacturers, contract development and manufacturing organizations (CDMOs), cellular therapy laboratories, and standard-of-care blood and marrow transplant programs. Title21 recently acquired MyCellHub to expand its digital capabilities in this space.

The company's core focus is replacing paper-based and fragmented workflows with integrated digital systems that support documentation, regulatory compliance, and end-to-end process visibility. Its software is designed to meet FDA 21 CFR Part 11 requirements and to support accreditation and quality standards across manufacturing and clinical operations.

Core Products and Modules

• Cell and Gene Therapy Orchestration Platform: A unified platform that consolidates documentation and quality processes across the full manufacturing workflow, addressing data silos created by paper-based or disconnected software systems.
• Manufacturing Execution System (MES): Covers cleanroom cleaning, cleanroom testing, electronic batch records, environmental monitoring, sample tracking, inventory management, equipment management, and device integration.
• Blood and Marrow Transplant (BMT): A dedicated solution for standard-of-care and transplant programs.
• Enterprise Quality Management System (EQMS): Provides integrated, configurable quality system modules designed to meet regulatory requirements including FDA 21 CFR Part 11.
• GMP Facilities Services: Support services for Good Manufacturing Practice facility operations.

Core Capabilities

• Manufacturing efficiency and scalability: Consolidates documentation across all manufacturing stages into a single location, eliminating reliance on a patchwork of paper and software tools.
• Regulatory compliance: Designed to uphold regulatory and quality standards throughout operations and manufacturing, with thorough traceability of every process step.
• Time-to-patient delivery: Provides complete process visibility to support data-driven decisions and reduce bottlenecks that slow patient delivery.
• Effortless documentation: Aims to make documentation straightforward for clinicians, nurses, lab technicians, administrators, and regulators alike.
• Real-time data-driven insights: Supports proactive problem-solving through access to live operational data.

Documented Customer Outcomes

• 13 hours per week of departmental staff time reallocated to operational duties
• 19 hours per week reduction in time spent managing document version control
• 82% decrease in hard copy manuals through implementation of electronic versions
• 208 days saved per year in employee time previously spent managing hard copy manuals

Industries Served

• Blood centers and biobanks
• CAR-T and biotherapeutic manufacturers
• CDMOs
• Cellular therapy laboratories
• Standard-of-care and blood and marrow transplant programs

Notable Customers and Partnerships

• University of Minnesota, which selected Title21 for its integrated, configurable quality system modules meeting FDA 21 CFR Part 11 requirements.
• Miller-Keystone Blood Center, which describes Title21 as a collaborative partner that responds to customer feedback with software solutions.

Title21 Health Solutions positions itself as a software partner for organizations seeking to digitize and scale cell and gene therapy operations while maintaining compliance with evolving regulatory requirements. The company offers demos and maintains dedicated support channels for both its core platform and the MyCellHub product line.

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Software attributed to Title21 Health Solutions

• Cell and Gene Therapy (CGT) Orchestration PlatformView

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