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GE Healthcare launches Chronicle GMP-compliant automation software for cell therapy manufacturing.
GE Healthcare’s Chronicle web application, the next generation development of the company’s my.Cryochain software, now supports the complete cell therapy workflow, the company announced in a May 15, 2019 press release. 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.
The 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 increase productivity, reinforce GMP compliance, and improve the security of patients’ samples through increased traceability. The software supports electronic standard operating procedures, which are designed for specific processes to manage deviations, promote adherence to protocol, and provide guidance to ensure sensitive patient cells are handled appropriately.
“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,” said Catarina Flyborg, general manager, Cell and Gene Therapy, GE Healthcare, in the press release. “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.”
“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,” said Olin Thomas, manager of Stem Cell Processing at Vanderbilt University Medical Center, in the press release.
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.
Source: GE Healthcare