CAR-T, Gene, Immuno and Cell Therapy Management System

Xybion digital lab solution provides a pre-configured LIMS and ELN product for CAR-T, Gene, Immuno and  Cell therapy labs. This is specifically designed to work on CAR-T therapy and other similar products that require managing biological samples, manage specialized reagents and work with third parties to ensure samples are tracked to the right patient. Through a configurable business process workflow engine, you can manage all aspects of your laboratory business operation from receiving customer samples/orders, test protocols and executions supported by digital QMS, DMS and GRC modules and final reports.   As an enterprise-ready solution, Xybion Digital Lab provides full lifecycle support for integrating critical, regulated workflow processes in a typical laboratory environment.

Key solution components

  • Portal for sample submission by hospital/clinic
  • Sample receipt
  • Sample storage
  • Protocol development & management
  • CAR-T production process management
  • Bar code reader
  • Data entry, data validation, and management
  • Deviation management & CAPA
  • Instrument management & calibration
  • Electronic daily diary management and reporting
  • People competency management
  • Task management, task allocation, and workforce management

Sample process steps

 

Other required solution components are built into the Labwise® XD Platform

Most traditional LIMS and ELN provides the core functionalities and require additional IT systems or significant manual processes to ensure other important business aspects such as documentation, deviation management, CAPA, audits and people competency. Xybion Lab Management Solution is one stop platform-based solution to provide the core and additional required solutions.

Key benefits:

  • Fully integrated digital workflow with internal and external stakeholders connected
  • Accurate tracking of samples throughout the entire lifecycle of CAR-T development
  • Lab productivity gain up to 45%
  • Reduction of data entry issues by over 90%
  • Improved visibility of tasks and better management of resources
  • Improve quality and reduce non-conformances
  • Manage people training, competency and quality documentation in a single compliant environment. The work environment is always compliant
  • Always ready for regulatory or any other external audits