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FDA approved a switchover from batch to the new technology for production of HIV drug Prezista, Darunavir on a line at its plant in Gurabo, Puerto Rico

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Above is an Illustration example,

FDA urges companies to get on board with continuous manufacturing

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……http://www.fiercepharma.com/manufacturing/fda-urges-companies-to-get-on-board-continuous-manufacturing

Darunavir
Darunavir structure.svg
Darunavir ball-and-stick animation.gif

SEE……http://www.en-cphi.cn/news/show-29367.html

Just after opening a refurbished manufacturing facility in Cape Town, South Africa earlier this year, pharma giant Johnson & Johnson ($JNJ) recently opened the doors to its Global Public Health Africa Operations office there.

The company has invested $21 million (300 million rand) in the facilities. The global public health facility will focus on HIV, tuberculosis and maternal, newborn and child health, South Africa – The Good News reported.

“This (investment) tells us that South Africa has the capability to provide a facility for world-class manufacturing,” Rob Davies, minister of the Department of Trade and Industry told the publication.

Johnson & Johnson, which has operated in South Africa for more than 86 years, planned to close the Cape Town manufacturing plant by the end of 2008 but was persuaded to keep the facility open for local manufacturing to serve sub-Saharan business. By 2015, the plant was cited by J&J as the most-improved in cost competitiveness from 30 company plants worldwide.

Earlier this month, the FDA gave J&J’s Janssen drug unit the go-ahead to proceed with the continuous manufacturing process it’s been working on for 5 years. The agency approved a switchover from batch to the new technology for production of HIV drug Prezista, Darunavir on a line at its plant in Gurabo, Puerto Rico.

AN EXAMPLE NOT RELATED TO DARUNAVIR

References

May 20-21, 2014    (Link to 2016 Meeting Website)

Continuous Bioprocessing

https://iscmp.mit.edu/white-papers/white-paper-4

READ

Achieving Continuous Manufacturing: Technologies and Approaches for Synthesis, Work-Up and Isolation of Drug Substance

https://iscmp.mit.edu/white-papers/white-paper-1

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//////FDA, HIV drug,  Prezista, Darunavir, Gurabo, Puerto Rico


Filed under: MANUFACTURING, PROCESS Tagged: continuous manufacturing, Darunavir, fda, Gurabo, HIV drug, Prezista, Puerto Rico

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