FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug

Regulatory NewsRegulatory News | 12 April 2016 |  By 

The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers.

The manufacturing change, announced last Friday, is for Janssen’s HIV-1 treatment Prezista (darunavir). And although Janssen isn’t the first manufacturer to use continuous manufacturing (Vertex’s cystic fibrosis drug Orkambi [lumacaftor/ivacaftor] has been using the continuous manufacturing process since its approval in July 2015), FDA is keen on pushing more manufacturers to this newer, more efficient process that can enable faster production and more reliable products.

FDA says that Janssen’s efforts in manufacturing advancement were facilitated by the use of FDA’s draft guidance from December, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base, which was developed by the agency’s Emerging Technology Team and designed to help manufacturers implement a variety of technological advancements.

“Although it is not easy for drug manufacturers to transition from batch to continuous manufacturing, there are significant rewards. FDA encourages others in the pharmaceutical industry to consider similar efforts,” Lawrence Yu, Ph.D., FDA’s deputy director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER), wrote in a blog post on Tuesday.

Like Dr. Yu, CDER Director Janet Woodcock has been advocating for continuous manufacturing since at least 2013 and told senators in January that she’s interested in seeing more manufacturers make the switch to continuous.

But others in industry are hesitant to predict that the pharmaceutical industry will make a rapid switch to continuous manufacturing, particularly as the technology has been around for decades and the industry has been slow to adapt.

Girish Malhotra, president of the pharma manufacturing consulting company Epcot International, who’s been writing about and discussing the switch to continuous manufacturing since 2005, told Focus that such a switch should have happened decades ago but it can be difficult for companies to make the switch while their product is still patented and large volumes of the drug are not needed.

“Under the current business model, it’s not feasible for brand drugs under patent unless you have a huge volume. It doesn’t make any sense,” Malhotra said.

But he also said generic drug manufacturers are prime candidates to switch to continuous manufacturing, particularly if the drugs they’re producing are high volume and they want to improve yields, lower costs and increase production capacity.

FDA blog post


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