Three years ago, Johnson & Johnson’s HIV drug Prezista was the only product approved by the FDA to be produced with continuous manufacturing. Now, there are four companies manufacturing five approved products using what the FDA calls CM processes. Twenty others are on the road to their own approvals.
The FDA however, wants to speed the process of moving an industry steeped in batch processing into “advanced manufacturing processes,” and so it is pitching in with money and guidance.
“Drug makers won’t switch to these systems until we create a clear path toward their adoption, and provide more regulatory certainty that changing over to a new manufacturing system won’t be an obstacle to either new or generic drug approvals,” Commissioner Scott Gottlieb said Tuesday in a statement. “The FDA recognizes that it’ll require additional investment in policies and programs that’ll provide regulatory clarity to enable these new methods to be more quickly and widely adopted.
Gottlieb and CDER Director Janet Woodcock Tuesday announced that the FDA has issued guidance on CM to speed up the switch and encourage those who are sitting on the fence about it. On top of that, the president’s 2019 budget includes nearly $60 million in funding to accelerate its own "architecture" to move forward new methods of drug manufacturing.
As Gottlieb sees it, continuous manufacturing systems and other new methods fit the trends in drug development, like personalized gene therapies. They can give drugmakers manufacturing flexibility, help with quality and lower the costs for patients of personalized and regenerative medicine products that target tiny patient populations that make large-scale manufacturing impractical. They can reduce months-long processes to a matter of days.
He suggested one approach would be to use a continuous manufacturing “cassette” for initial clinical supply. That way the scaling of manufacturing for larger trials wouldn’t require the build-out of a completely new manufacturing facility, he said. Drugmakers could move to larger trials and then commercial productions by plugging additional manufacturing cassettes into the process.
“This could have a transformational effect on the costs and feasibility of applying gene therapy to rare diseases,” the commissioner said.
He sees great potential in new processes to deal with some of the key complaints the FDA continually faces with drug production. They could allow drugmakers to scale up to deal with drug shortages. They could also help vaccine makers mitigate the ineffectiveness of some flu vaccines by producing them closer to the flu season when there is more certainty about the circulating strain.
“These advanced platforms are small footprint operations. They require a reduced complement of more highly skilled workers. It’s the sort of manufacturing where America excels,” Gottlieb went on. “Producing more drugs domestically doesn’t just mean more American jobs. It could also reduce import costs for manufacturers and increase security of our supply chain.”