- GMP compliant software specifically designed for cell therapy manufacturing from process development through commercialization
- Digital optimization for increased productivity and improved process control
GE Healthcare builds on its digital capabilities with the Chronicle web application, the next generation development of my Cryochain™ software now supporting the complete cell therapy workflow. Chronicle automation software is a GMP compliant fit-for-purpose digital solution designed to optimize complex cell therapy process development and manufacturing. With real-time supply chain tracking, hardware performance monitoring, SMS or email alarms, and comprehensive electronic batch records, Chronicle automation increases efficiency while meeting regulatory compliance.
Chronicle automation software capabilities include:
- a unified digital space that monitors all facility manufacturing operations and supply chain logistics with real-time data acquisition and notifications
- electronic batch records that trace every manufacturing step with automation to increase productivity, reinforce GMP compliance, and improve the security of patients’ samples through increased traceability
- eSOPs designed for specific processes to manage deviations, promote adherence to protocol, and provide guidance to ensure sensitive patient cells are handled appropriately
Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare, said: “The full potential of cell and gene therapies cannot be realized without comprehensive digital solutions that optimize manufacturing processes and can scale from process development to commercialization. Chronicle automation software was designed to meet the digital needs of academic researchers and large biotechnology companies and will help ensure increased patient access to life-saving therapies.”
Olin Thomas, Manager of Stem Cell Processing at Vanderbilt University Medical Center, said: “Automation software provides our lab with a flexible digital solution that streamlines our workflow. Because the software was designed to fit our specific requirements, we have been able to incorporate the platform into our existing software and hardware framework for a seamless integration.”
Built by cell therapy platform solution engineers, Chronicle software integrates with the full range of GE instruments as well as many third-party instruments. It has been independently audited against GAMP5, 21 CFR Part 11, and EU Annex 11 and is available immediately.