Cell and gene therapy firms are not ready to fully embrace artificial intelligence (AI) says an official at the US subsidiary of Hitachi Chemical, who thinks developers and manufacturers must learn to automate production first. The Japanese conglomerate cemented its presence in the cell therapy contract manufacturing space in January with the opening of a facility in Allendale, NJ. The facility, which is operated by Hitachi Chemical Advanced Therapeutics Solutions (HCATS), is the first designed “to meet the unique needs of commercial cell and gene therapy products,” according to Thomas Heathman, PhD, HCATS’ business leader in North America.

These needs include being able to vary output, he continues, adding that it is harder to predict approval timelines and commercial demand for cell therapies than for other biopharmaceuticals. “We have built out our infrastructure in a modular manner so that we can build specific capacity to meet commercial customer needs as we get a clearer picture of the forecasts and needs.”

Data exchange is also built into the plant’s design. “Manufacturing Execution Systems and LIMS systems are being implemented to move from paper systems to electronic and enable seamless data flow throughout the facility,” he points out.

A focus on data and greater interconnectivity in manufacturing is something other cell and gene therapy firms should consider.

“The cell and gene therapy industry is not quite ready for advanced manufacturing systems such as AI. We are really at the point of product understanding and transferring processes from manual to semi-automated systems,” he says. “The next phase after that would be full automation, and then on to AI and other advanced technologies to make critical process decisions based on manufacturing data.”

This view is shared by David Smith, PhD, HCATS’ R&D director.

“There is a growing need as the volumes increase to rely less on manual operations and move towards automation,” he explains “This is not only for process, where most people concentrate efforts, but also on testing and all other manufacturing associated functions to include quality assurance, supply chain and storage. Therefore, not only is there a need for process automation with companies like Ori Biotech, but also in-line sensing for analytics such as those Sartorius is working on, as well as electronic systems like LIMS, MES, and Enterprise Resource Planning to help bring everything together without the need for unreliable physical human input.”

Automation has applications across the whole lifecycle of a product, but the high cost of labour and need for reproducibility within manufacturing functions really drive the need, Smith says.


HCATS’ facility also houses a development laboratory. The idea is to help customers improve processes and integrate novel manufacturing techniques as the sector develops, notes Heathman.

Embracing innovation is also critical for cell and gene therapy developers, according to Smith, who says techniques and technologies are advancing quickly. “There is a vast increase in the development of non-viral genetic engineering solutions, such as Avectas, Kytopen, SQZ Biotech, that are generating novel methods to add or remove genetic material to cells, therefore enhancing their function.”

Demand for more advanced hardware is also a factor Smith says, explaining “There is a drive for suppliers of software solutions to start spreading their reach.  We see software companies now increasing capabilities to not focus on one facet but incorporate adjoining needs, like an MES company offering LIMS or Track and Trace, with companies like Werum, L7 and Vineti.”

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