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Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realised, says Rutgers University which has received an R&D grant from J&J.
The $6m (€5m) investment from Johnson & Johnson will be used to support research efforts and help implement a specially designed manufacturing line at a Janssen facility in Puerto Rico, as part of its ongoing collaboration with the Rutgers University School of Engineering to help bring continuous processing techniques to the pharma industry.
“While our group and others have been working at this for almost a decade adoption of the technology has just begun in the last year or so,” Douglas Hausner, Associate Director for Industrial Relations and Business Development at Rutgers told in-Pharmatechnologist.com. “FDA approval for the first adopters are just beginning to happen now.”
He told us how the research efforts had originally comprised of a few industry scientists and that most outside of that group thought this would never get the US Food and Drug Administration (FDA) to accept a continuous processing approach.
“That changed a few years ago when the FDA began to actively promote the technology and encourage adoption. Then engineering and manufacturing people at companies got involved and interested. Now as this is making its way to market, regulatory people within the companies are joining in.”
Hausner continued: “All in all, this is a highly regulated industry that is slow to change, at least with respect to manufacturing technology,” but recent dialogue seems to suggest industry and regulators are now on board.
Earlier this month , the FDA’s Janet Woodcock called on drugmakers to begin the switch from batch manufacturing, offering grants to innovation and pushing for legislation and guidance, stating continuous processing “is the future.”
Going to Market
As part of ongoing R&D, Rutgers designed and built “the first continuous direct compression line and demonstrated that a large number of products that currently require more complicated batch manufacturing methods can be made using this approach,” Hausner said.
This was the model for the continuous processing line at Janssen’s Puerto Rico plant, but that design has also been implemented at other large pharmaceutical company R&D facilities including Bristol-Myers Squibb and Eli Lilly.
“Those companies are now all going to market with this technology,” Hausner added.
In-Pharmatechnologist.com recently spoke to a Tim Jamison, an MIT Professor and founder of continuous flow chemistry solutions firm Snapdragon Chemistry, who said that while industry and regulators have begun embracing such techniques, a lack of talent could temporarily hamper a shift from batch production.
Hausner agreed, but added this problem is being addressed: “This technology requires a different way of thinking and training. This is needed for current as well as new personnel.
“We have developed training for the FDA and we are working on developing an international institute which will be a coalition of research groups like ours worldwide. This will work on standardizing curriculum and other aspects related to training.”
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