Janssen's Historic FDA Approval

April 13, 2016
The FDA has approved -- for the first time in history -- a manufacturer’s production method change from “batch” to continuous manufacturing.

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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 

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'