Rutgers leading continuous manufacturing guidance efforts

J&J success will spur pharma's shift to continuous manufacturing, Rutgers

By Dan Stanton

- Last updated on GMT

Image: iStock/farakos
Image: iStock/farakos

Related tags Continuous manufacturing Research and development Food and drug administration Fda

Industry will be encouraged to adopt continuous manufacturing methods following the regulatory success of Janssen’s Prezista, says Rutgers University associate director and Interphex speaker Doug Hausner.

Earlier this month​, the US Food and Drug Administration (FDA) approved J&J subsidiary Janssen manufacturing method for its HIV drug Prezista (darunavir) at its plant in Puerto Rico signalling a first in the industry in changing from batch to continuous production.

The shift was the accumulation of years of development between the firm and Rutgers University, and while the team is already working on continuous manufacturing methods for other Janssen drugs, Rutgers’ Associate Director for Industrial Relations and Business Development with the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) Doug Hausner said this would encourage greater adoption within the industry as a whole.

Ahead of his appearance at industry show Interphex, he told more approvals will come through from many of the big pharma manufactures who have committed to continuous manufacturing, such as GSK, Pfizer​ and Novartis​.

“Beyond the large committed players adoption has been slow, but interest has been high. As more approvals occur, companies will shift closer to adoption,”​ he said.

“There have been a number of other applications working their way through the FDA over the last year as well, including some that we have been involved in. We will be seeing those approvals in the next few months most likely.”

Regulatory support and future guidance

The past twelve months have been “seminal”​ for continuous manufacturing, Hausner told us, with increased support and investment from the FDA to make such techniques a reality in the pharma industry. Janet Woodcok, for example from the Agency’s CDER described continuing processing as “the future”last May​.

“We have been quite fortunate as a research center to earn the support of Dr. Woodcock, the agency, and industry.  Over the last two years since the inception of the FDA's Emerging Technology Team - the one that deals with continuous both research and approvals - our relationship has grown ever stronger.” 

He added Rutgers has become “a key piece of the FDA's strategy for developing continuous manufacturing as a technology for pharmaceutical solid dose manufacturing,”​ and, on Woodcock’s request, is coordinating an industry group to work on a best practices potential guidance document.

“That is an unfunded effort, but something we are happy to do for industry and the FDA.”

Expediting small molecule development @Interphex

Doug Hausner will present his talk entitled ‘Continuous Manufacturing for Rapid Process Development’ at Interphex, New York on Wednesday 27 April.

“Continuous manufacturing has enormous potential for expediting the development of small molecule targets,”​ especially for targeting outbreak type diseases like avian bird flu, SARS, MERS, and Ebola,he told us.

“We currently have a pre-proposal submitted in response to a FDA/BARDA [Biomedical Advanced Research and Development Authority] on rapid development using continuous manufacturing. I will be speaking about this topic at Interphex. A speaker from BARDA is also in my session.”

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