Thermo provides hot-melt tech to US continuous manufacturing researchers

By Gareth Macdonald

- Last updated on GMT


Related tags Pharmacology

Thermo Fisher Scientific has provided Rutgers’ researchers with hot-melt extrusion tech to support development of continuous manufacturing for drug production.

The technology - a Pharma 11 twin screw extruder – will be housed at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) in New Jersey. It will be used to trial extrusion and wet granulation for the production of solid dose drugs.

Douglas Hausner, Associate Director for Industrial Relations and Business Development at Rutgers, told us Thermo charged less than half of the market price for the technology.

He added that it “strengthens our capabilities in both twins screw granulation and HME" ​explaining that "previously we only had access to such equipment at our other partners school sites.​  

Now with the unit at Rutgers we have the ability to integrate the technology into a full continuous line and explore process development much further for products that require this technology​.”

Continuous manufacturing

In April​ the US Food and Drug Administration (FDA) cleared Janssen to change the production method for the 600mg version of the HIV drug Prezista (darunavir) from “batch” to continuous manufacturing.

The new continuous production method was developed in partnership with the Rutgers University.

According to Hausner the hot-melt extrusion platform will be available to drug companies that work with C-SOPS researchers.

He told us "The technology is available to industry through C-SOPS where companies can sponsor an individual evaluation or development project or do so as part of a multi company group.

"We work very closely with industry and have helped to develop commercially approved processes. We can now do that for processes that involve TSG or HME​."

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