Bio-Cell

Bio-Cell is a laboratory information management solution developed by Bio Lims Inc for cellular and gene therapy workflows. It provides end-to-end information traceability management covering the full treatment lifecycle, from medication application and sample collection through preparation, quality inspection, and reinfusion. The system is designed for organizations working in regenerative medicine where therapies are highly personalized and require precise tracking of each patient's cells from harvest to drug administration.

Bio-Cell addresses two core compliance requirements in cell and gene therapy: Chain of Compliance (CoC), which ensures every step adheres to relevant regulations and standards, and Chain of Identity (CoI), which verifies product identity and traces the origin and destination of materials to prevent forgery or confusion. The platform maintains tamper-proof data records across personnel, machinery, materials, methods, and the environment throughout the entire process.

Key Challenges Addressed

• Managing the complexity of highly personalized therapies that require precise control and monitoring at every stage of production
• Maintaining compliance with an evolving regulatory landscape and adapting quickly to new guidelines and requirements
• Handling the logistics of shipping, storing, and distributing perishable therapies that require specialized handling to preserve viability
• Collecting, analyzing, and reporting clinical outcome data to monitor therapy effectiveness and safety over time

Core Functional Modules

• Donor Information and Patient Treatment Application: A secure electronic system for capturing and managing donor information and patient treatment applications, recording all relevant data while maintaining patient confidentiality and tracking treatment progress from application to outcome.
• Sampling Plan and Sampling Management: Defines detailed protocols for sample collection, tracks progress against the plan, ensures consistent and reliable sample collection, and manages proper labeling and storage for subsequent analysis.
• Shipping Monitoring: Uses specialized shipping containers and tracking technology to monitor sample conditions during transportation, including temperature and humidity levels, with rapid identification and resolution of any deviations.
• Sample Reception: Ensures samples are properly received, logged, and stored in a timely manner, with identification and resolution of any discrepancies or issues upon arrival.
• Sample Storage: Supports storage of samples in conditions that preserve their integrity and viability, using appropriate facilities and equipment for subsequent analysis.
• Cell and Gene Preparation: Allows configuration of multiple standardized protocols and procedures for cell and gene preparation, ensuring consistency and flagging any deviations from established protocols.
• Quality Control (QC): Supports a rigorous QC program with regular testing and analysis of samples to verify quality and safety, enabling timely identification and resolution of quality issues before samples are used in therapy preparation.
• Quality Assurance (QA): Includes a program of regular audits and inspections across all processes and procedures to confirm correct execution and identify and correct any deviations.
• Product Release: Manages a product release process that includes comprehensive testing and analysis, ensuring only therapies meeting all relevant quality and safety standards are released for distribution.
• Clinical Outcome Tracking: Provides a system for collecting, analyzing, and reporting data on the effectiveness and safety of therapies over time to support continuous improvement of patient outcomes.

Traceability and Data Integrity

• Links individual patient identification to all stages of cell processing and drug administration
• Records event information for all processes and transfers from cell harvesting through to drug administration
• Captures auxiliary data including temperature logs during shipment and detailed manufacturing records
• Maintains tamper-proof records across the full process to support regulatory compliance and audit readiness

Bio-Cell is positioned for use in clinical and manufacturing environments operating under regulated cell and gene therapy frameworks. The solution supports the holistic management of people, equipment, materials, methods, and environmental conditions required to meet Chain of Compliance and Chain of Identity obligations throughout the therapy lifecycle.