Robots are the solution to the cell and gene therapy sector’s manufacturing challenges, according to researchers, who say combining them with artificial intelligence (AI)-based control will help developers automate production.
The conclusion comes from a joint paper by the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT), who set out to identify the bottlenecks in manufacturing.
And there are challenges at every stage of production, some of which are due to the sector’s rapid growth rate, says lead author Fermin Sanchez-Guijo, PhD, head of the hematology department & cell therapy area at University Hospital of Salamanca in Spain.
“Among the most important manufacturing challenges in Europe and the rest of the world are the enormous needs that will arise in terms of both production demand and skilled production personnel, due to the large number of new advanced therapy medicinal products (ATMPs) that are being approved and will be approved in the next decade by regulatory agencies.”
The global cell and gene therapy market is small in terms of the number of products available. For example, at present, only 33 cell and gene therapies (CGTs) are approved in the United States, while just 24 ATMPs are cleared in the EU.
However, the market is expected to grow significantly over the next few years—according to U.S. industry group PhRMA more than 480 CGTs were in development as of 2022—which will likely further increase demand for skilled production staff.
Automation
Manufacturing technologies also need to improve, according to Sanchez-Guijo, who predicts the allogeneic cell therapy sector—rather than developers of patient-specific therapies—will drive innovation.
“The manufacture of ATMPs of autologous origin will always be burdened by the need for laborious production in terms of cost and time, but these are the products we currently have.
“The great leap must be made with the optimization of allogeneic products that are immediately available and can be generated on a large scale. In this line, the use of bioreactors and other automated production tools will reduce manufacturing times and costs.”
The good news is that the elements needed to automate cell and gene therapy production are already available, they just need to be combined, Sanchez-Guijo says.
“The automation and robotization of processes is in a preliminary phase, but it is undoubtedly the future, for large scale and homogeneous production, reducing variability, costs, and time.
“Artificial intelligence will help us in many of these processes, from a better design of genetic constructs based on an integrated analysis of scientific evidence, to the optimization of processes or the selection of the best personalized product for a specific patient, based on the integrated knowledge generated by any previously treated patient with a similar clinical condition or product.”
