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Yesterday, Lawrence Yu, FDA’s Deputy Director, wrote a blog post about a landmark event for continuous manufacturing.
The FDA has approved -- for the first time in history -- a manufacturer’s production method change from “batch” to continuous manufacturing.
This new approval is for manufacturing Janssen Products' medication for the treatment of HIV-1 infection, Prezista (darunavir), at Janssen's Gurabo, Puerto Rico, plant.
While even the FDA admits the transition from batch to continuous is "not easy," the agency is encouraged by the fact that it is seeing a growing number of manufacturers working towards building continuous manufacturing into their processes.
For Janssen, the decision to introduce CM into its operations was neither undertaken lightly nor made over night. According to Mauricio Futran, VP of Advanced Technology for Janssen Manufacturing & Technical Operations, Janssen's collaboration with Rutgers University Engineering Research Center for Structured Organic Particulate Systems began nearly 10 years ago. “We share this commitment to enhance the technology we use for manufacturing,” says Futran, noting that the CM strategy evolved gradually from that philosophy, and about five years ago the initiative to develop a continuous manufacturing approach rose to become a top priority for the group. “We watched the technology develop and when it really got to where we felt it offered an opportunity to support an appropriate proof of concept, we decided to pursue it and learn how to bring it online.”
"Progress comes at an opportune time," concludes Yu.
Read the full story about Janssen's CM efforts
Read the FDA blog post
