Pressure to make cell and gene therapies more affordable will force the industry to overcome its reticence and embrace closed production systems, automation, and artificial intelligence (AI). So says, Gerhard Bauer, ex-director of the UC Davis GMP manufacturing facility and co-author of a new study examining cell and gene therapy production in the United States.
“New manufacturing technologies are under development but have not made it into commercial product manufacturing to a large extent. The well-known and trusted processes that have been applied for many years are still dominating manufacturing.
“This has a lot to do with the regulatory background commercial CGT manufacturing has to operate in. Any process changes require comparability studies and validations, followed by regulatory amendments. This is risky, time-consuming, and expensive,” he tells GEN.
The potential benefits of automation are such that, eventually, most producers will adopt it, according to Bauer, who cites the ability to reduce the high cost of goods (COGs) associated with cell and gene therapies as an example.
“To my mind, it is unavoidable that automated, closed system CGT product manufacturing will need to be introduced and applied to supply the products to all patients in need and to lower the cost.
“We will see a rise in new CGT products for a lot of different diseases, and how would we manufacture these products without automation? Still, a lot of effort needs to go into changing the manufacturing environment over the next years,” he says.
Industry demand will drive this change according to Bauer, who predicts that developers will favor contract manufacturers with the know-how and technologies to ensure quality and reduce costs.
“The complicated nature of cell and gene therapy manufacturing may lead to a ‘trust’ issue. Developers want to make sure their product will be manufactured by groups with an excellent track record and for a reasonable price,” he said.
Cell and gene therapy manufacturers that adopt automated bioprocessing technologies are also likely to use AI, according to Bauer, particularly in areas like QA/QC and batch release.
“I can envision that AI may play a role in supervising automated product manufacturing, improving product consistency, and allowing for automated quality control.
“However, human interaction with AI will be absolutely necessary, as AI can also make mistakes, we always need to keep in mind that these products will be administered to patients whose lives we want to save,” he said.
The post Automation, AI, and Closed Systems in Cell and Gene Therapy Production appeared first on GEN - Genetic Engineering and Biotechnology News.
“New manufacturing technologies are under development but have not made it into commercial product manufacturing to a large extent. The well-known and trusted processes that have been applied for many years are still dominating manufacturing.
“This has a lot to do with the regulatory background commercial CGT manufacturing has to operate in. Any process changes require comparability studies and validations, followed by regulatory amendments. This is risky, time-consuming, and expensive,” he tells GEN.
Potential benefits
The potential benefits of automation are such that, eventually, most producers will adopt it, according to Bauer, who cites the ability to reduce the high cost of goods (COGs) associated with cell and gene therapies as an example.
“To my mind, it is unavoidable that automated, closed system CGT product manufacturing will need to be introduced and applied to supply the products to all patients in need and to lower the cost.
“We will see a rise in new CGT products for a lot of different diseases, and how would we manufacture these products without automation? Still, a lot of effort needs to go into changing the manufacturing environment over the next years,” he says.
Industry demand will drive this change according to Bauer, who predicts that developers will favor contract manufacturers with the know-how and technologies to ensure quality and reduce costs.
“The complicated nature of cell and gene therapy manufacturing may lead to a ‘trust’ issue. Developers want to make sure their product will be manufactured by groups with an excellent track record and for a reasonable price,” he said.
Human AI interaction
Cell and gene therapy manufacturers that adopt automated bioprocessing technologies are also likely to use AI, according to Bauer, particularly in areas like QA/QC and batch release.
“I can envision that AI may play a role in supervising automated product manufacturing, improving product consistency, and allowing for automated quality control.
“However, human interaction with AI will be absolutely necessary, as AI can also make mistakes, we always need to keep in mind that these products will be administered to patients whose lives we want to save,” he said.
The post Automation, AI, and Closed Systems in Cell and Gene Therapy Production appeared first on GEN - Genetic Engineering and Biotechnology News.