Abstract
As more and more cell and gene therapies are being developed and with the increasing number of regulatory approvals being obtained, there is an emerging and pressing need for industrial translation. Process efficiency, associated cost drivers and regulatory requirements are issues that need to be addressed before industrialisation of cell and gene therapies can be established. Automation has the potential to address these issues and pave the way towards commercialisation and mass production as it has been the case for ‘classical’ production industries. This review provides an insight into how automation can help address the manufacturing issues arising from the development of large-scale manufacturing processes for modern cell and gene therapy. The existing automated technologies with applicability in cell and gene therapy manufacturing are summarized and evaluated here.
Highlights
Automation has the potential to address many of these existing challenges, while facilitating the requirements for regulatory and marketing approval
While the advanced therapy manufacturing is already profiting from automation approaches that have been used successfully in the ‘traditional’ production industries for a long time, it does not yet fully exhaust the potential of advanced manufacturing approaches which are currently being developed by the industry 4.0 (Kulik et al 2016)
Automation and enabling technologies such as digitalisation, process analytical technologies and data processing have the potential to change the way we develop and produce cell and gene therapies
Summary
Cell and gene therapies are medicinal products that utilise cells and genes to treat disease. The Cellmate system (Sartorius) is another example that operates under the same principle allowing for higher volume expansion of cells in roller bottles and T-flasks without process change This system is currently used by ReNeuron for the larger scale batch manufacture of their CTX stem cell therapies for stroke, as they move to phase III clinical trials (‘‘ReNeuron to use Cellmate automated cell culture for stem cell-based stroke therapy—Cambridge Network’’ 2015). While the aforementioned platforms are suited for automated plate-based processes in high-throughput, they have limited applicability for cell and gene therapy production due their poor scalability and transferability to stirred tank systems Platforms such as the Ambr15Ò and Ambr250Ò (Sartorius) revolutionized process development by introducing high-throughput options for cell culture, while using single use, disposable bioreactor vessels in an automated processing setting using an automated liquid handler. These platforms would be fully integrated, yet modular, allowing for flexibility which is key to the ever-evolving field of cell and gene therapy manufacturing
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