As production of cellular therapies scales from clinical trials to market authorization and beyond, manufacturing companies and research groups face multiple challenges. These include maintaining consistency in freezing and thawing across multiple sites, and auditing remote processes, particularly at the thawing stage. Asymptote developed my.Cryochain to provide a reliable and scalable solution which can support Good Manufacturing Practice (GMP).
The new software synchronizes with Asymptote’s VIA Freeze range and soon-to-be released automated thawing systems. Authorized users then have centralized control over the freezing and thawing of cells; critical to the delivery of cell and gene therapies. Optimal freeze/thaw profiles can be customized in the central system during process qualification. Once approved, they are synchronized across all connected equipment, to remove variability and standardize 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-synchronized to all equipment in the field.
The my.Cryochain 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 more easily identify anomalies and document observations. All data is automatically stored in the central system, where it can be backed up and protected for five years or more.
my.Cryochain 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.
Commenting on the commercial launch of my.Cryochain, John Morris, CEO, Asymptote said: “We have developed my.Cryochain to enable cell therapy companies and scientists to have centralized control over freezing and thawing of cellular therapies. The ability to define freeze/thaw profiles centrally during process qualification and synchronize these to their VIA Freeze units and automated thawing systems enables processes to be standardized 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 securely host in the cloud or install on-premise, behind a customer’s own firewall. For more information visit http://my.cryochain.com
my.Cryochain will be on display at the Asymptote stand, number 41, at the Cell Therapy Manufacturing & Gene Therapy Congress, Amsterdam on 29 & 30 November 2016.
About Asymptote
Asymptote combines world leading research into the science of cell freezing with engineering expertise to create pioneering cryochain technology for advanced medicines. Our portfolio of innovative products preserve cell viability during cryogenic processing of cellular therapies – their freezing, shipping and thawing – to support our customers’ work to improve healthcare throughout the world.
Asymptote’s cryochain technology comprises of integrated hardware, software and consumables. Our my.Cryochain software is the only platform developed specifically to control the cryochain of cellular therapies. All Asymptote’s hardware synchronizes with my.Cryochain to standardize processes at all sites and centrally audit remote data. Our liquid-nitrogen free, GMP compatible equipment - the VIA Freeze range of controlled rate freezers, the up-coming VIA Shipper and the automated thawing systems for cryobags and cryovials - manage the end-to-end cryochain. Cryochain consumables are in development, these include IceStart, an ice nucleator to ensure consistent freezing in multiwell plates. For further information visit www.asymptote.co.uk
About John Morris, CEO, Asymptote
John Morris is a co-founder of Asymptote Ltd, a Cambridge based SME, which combines world leading research into the science of cell freezing with engineering expertise to create pioneering cryochain technology for advanced medicines. Prior to Asymptote, he worked as Research Director of a number of biotechnology companies and as a Research Scientist with the Natural Environment Research Council. John did his PhD on the cryobiology of T cells within the Medical Research Council's division of Cryobiology, and has over 200 publications in the field of cryopreservation.
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Lorna Cuddon, Zyme Communications
Email: lorna.cuddon@zymecommunications.com
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