Cell and gene therapy developers looking to move to commercial manufacture should embrace innovative systems, says new U.K.-based technology supplier Cellular Origins. Firms sometimes struggle to scale up production processes developed in the lab, according to CEO Edwin Stone, PhD.
“Therapy developers either have to redevelop their process for high volume manufacturing solutions or stick with a time consuming, expensive manual process,” he tells. “Currently they typically do the latter.”
But redeveloping processes is a step worth taking.
“Labor makes up approximately 50 percent of the manufacturing costs of cell therapies. With the right technology, the manufacturing cost could be reduced by 70 percent, which could make a single curative course of treatment cost comparable with other biologic immunotherapies that require multiple courses of treatment, says Stone.
Stone points to the impact Industry 4.0 ideas, digital production technologies, and automation have had on the wider manufacturing sector as an indication of what the cell and gene therapy sector has to gain.
Advances are relevant and mature
“We need to embrace how other industries have scaled. Their advances are both highly relevant and increasingly mature,” continues Stone. “Biopharma can learn from how other industries have used automation. Amazon, for example, has transformed its supply chain with Kiva robots while the semiconductor sector has relied on automation and robotics to greatly reduce damaging particulate contaminants. Some of these ideas can be applied to drug manufacturing.
“With industry 4.0 ideas and technology you connect the physical and digital worlds. Using this approach in cell therapy manufacturing would help developers track materials through the production process, minimize labor requirements, and reduce the risk of human error.”
Cellular Origins separated from parent organization TTP earlier this month with the aim of helping cell and gene therapies firms combine manufacturing technologies as effectively as possible.
“We will supply manufacturing technology that joins processes together,” says Stone. “Our differentiation is that we are working with, rather than trying to replace, all of the exciting technologies that are already on and coming to the market to help therapy developers create better cell therapies.
“In some ways we are enabling therapy developers remove one of the main barriers to manufacture that may otherwise push them to a CDMO by greatly reducing both the labor and floorspace they need to manufacture a therapy,” Stone says, adding “In doing this we are making manufacture at scale more accessible.”