Software platform centralises control of cryogenic cold chain
December 7, 2016
Asymptote has launched a software platform to give centralised control of the cryogenic cold chain for cellular therapies.
As production of cellular therapies scales from clinical trials to market authorisation and beyond, manufacturing companies and research groups face multiple difficulties. These include maintaining consistency in freezing and thawing across multiple sites, and auditing remote processes, particularly at the thawing stage.
UK firm Asymptote developed My.Cryochain to provide a reliable and scalable way to support GMP good manufacturing practices.
The software synchronises with Asymptote’s Via Freeze range and automated thawing systems. Authorised users then have centralised control over the freezing and thawing of cells, critical to the delivery of cell and gene therapies.
Optimal freeze and thaw profiles can be customised in the central system during process qualification. Once approved, they are synchronised across all connected equipment to remove variability and standardise processes.
My.Cryochain automatically manages profile versions to support continuous improvement. When a process enhancement is identified, the history of all changes is automatically recorded and the new profile is re-synchronised to all equipment in the field.
The platform enables users to record, annotate and audit cryopreservation processes electronically. The system provides instant and remote access to data from every Via Freeze and automated thawing system, thereby saving scientists’ time and increasing efficiency. A full electronic audit trail also enables scientists to identify more easily anomalies and document observations. All data are automatically stored in the central system, where they can be backed up and protected for five years or more.
It has been developed as a scalable system to suit every stage of clinical development, from early clinical trials and investigational work to mass production and delivery, with thousands of connected Via Freeze units and automated thawing systems across multiple continents.
“We have developed My.Cryochain to enable cell therapy companies and scientists to have centralised control over freezing and thawing of cellular therapies,” said John Morris, CEO of Asymptote. “The ability to define freeze-thaw profiles centrally during process qualification and synchronise these to their Via Freeze units and automated thawing systems enables processes to be standardised across all sites. Real-time and sustained access to data from the equipment allows remote processes to be audited and improvements made swiftly. For the first time, manufacturers and scientists will have control of the end-to-end cryogenic cold chain.”
My.Cryochain is available now with options to host securely in the cloud or install on-premise, behind a user’s own firewall.