FDA urges companies to get on board with continuous manufacturing

Janssen's Prezista continuous manufacturing line
Janssen's Prezista continuous manufacturing line

A handful of companies have done pioneering work with continuous manufacturing, the production process that is faster, cheaper and less prone to the kinds of manufacturing mess-ups that worry the FDA. Now that the FDA has for the first time approved a company switching production of a drug from batch to continuous manufacturing, the agency is inviting others to get on board with the process.   

The FDA gave Johnson & Johnson’s ($JNJ) Janssen drug unit the thumbs up last week for the continuous manufacturing process that it has been working on for 5 years. The agency approved a switchover from batch to the new technology for production of HIV drug Prezista on a line at its plant in Gurabo, Puerto Rico.

“Although it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards,” Lawrence Yu, the FDA’s deputy director for the Office of Pharmaceutical Quality, said in a blog post Tuesday, noting the hallmark event. “FDA encourages others in the pharmaceutical industry to consider similar efforts.”

Yu pointed out the kinds of benefits that for a decade have led drugmakers to study what it would mean to transition some products from the century-old batch processing methods to more efficient continuous manufacturing. It is faster and so cheaper. He pointed out that in some cases, production time can be cut from a month to a single day.

“Of course, speed alone would not matter if continuous manufacturing compromised quality,” Yu said. “But by eliminating breaks between steps and reducing opportunities for human errors during the stops and starts in the batch process, continuous manufacturing is more reliable--and safer. That’s a powerful combination.”

The office that Yu oversees was created because of the FDA’s growing focus on quality manufacturing. The FDA has said for several years that if drugmakers would give more heed to the highest quality manufacturing, it would help keep them from having regulatory problems that lead to plant closures and costly fixes. Fewer plant closures also mean fewer drug shortages that occur from that cycle, another of the agency’s top priorities.

“Continuous manufacturing also allows manufacturers to respond much quicker to changes in demand, potentially contributing to prevention of drug shortages,” Yu said.  

Janssen has been working for 5 years with Rutgers University and the University of Puerto Rico on the technology, which it says integrates weighing, milling, blending, compression and coating into a single line. The process requires less production space: two rooms instead of 7 for J&J. It also allows real-time release testing, so shortening the production timeline in the case of Prezista from two weeks to a single day. If a correction is needed, an entire batch does not have to be dumped.

Janssen says now that it has an approval of its methods, it is looking to use the technology to manufacture 70% of its highest-volume products. Other drugmakers can thank the company for helping establish a regulatory pathway for approval of continuous manufacturing.

While J&J switched an approved drug from batch to continuous manufacturing, other companies are building plants so products can use continuous manufacturing from the get-go. Yu pointed out that Vertex ($VRTX) built a continuous manufacturing plant in the Boston area to produce Orkambi, the cystic fibrosis drug approved last year.  

“FDA will continue our efforts to encourage the advancement of continuous manufacturing as one of a variety of ways to enhance the quality of the medications used by the American public,” Yu said.

- read the blog post