Anglo-Spanish firm Aglaris has developed an autonomous, closed production system for the manufacture of cell therapies such as T-cells and MSCs (Mesenchymal Stem Cells). According to new CEO Steven Docksey, the platform overcomes many issues associated with this new product class.
“Most current processes are intensive, manual techniques derived and scaled-up from the cell preparation techniques used in research labs – adapting existing tools to the job. There is little in the way of genuine innovation that has come to market to address the specific needs of this new class of therapeutics,” Docksey, who joined Aglaris as CEO earlier this month, told BioProcess Insider.
He added current practices lack the traditional depth of GMP and CMC principles well-tested across other areas of biomanufacturing. The time to manufacture a batch is too long and complex, he continued, with too much manual intervention, particularly in autologous applications.
“We are dealing with a new product class – a living therapeutic derived from individual patients performing in a highly complex immunological environment – an inconsistent starting point but a need for a consistent end product.”
Aglaris’ Facer technology looks to overcome these issues by using an expansion process built around the proven cell culture methodology of the client. “It does not need a new process to be developed,” Docksey said.
“[The] system is designed from the start to deliver critical manufacturing confidence missing in current cell-based therapies manufacturing,” and include single-use equipment, closed systems, and automation he says offers convenience, scalability and an ease if to change from adherent to suspension culture.
Compared to other technologies available to cell therapy developers, Aglaris’ platform delivers greater and faster output, Docksey said. “It makes more cells in a defined time or the same number of cells in a shorter time, delivering about 25% higher performance.”
He added the platform is more robust and easier to adopt than other market offerings. “It has been designed from the ground up to be a manufacturing system for cell-based therapies – automated, intelligent, no operator intervention, scalable, compliant, eliminates operator intervention in the expansion process, real-time data tracking of the process.”
Docksey took the role of CEO at Aglaris having previously held senior leadership and operational roles with Merck Millipore, Sartorius Stedim Biotech and GE Healthcare.
When asked about his strategy for Aglaris going forward, he told us he is looking to establish industrial credibility, innovate further, and launch the Facer system for manufacturing and commercialization towards the end of 2019.
“We are currently raising funds to support final trials and data generation on a range of clinical streams with leading pharma companies and manufacturers. We anticipate leading pharma companies will use the Facer platform to support clinical trials to GMP standards within the next 18
months and for the Facer platform to be formally integrated into their processes.”