EMA clears Janssen to make HIV drug using continuous manufacturing approach

By Gareth Macdonald

- Last updated on GMT


Related tags Continuous manufacturing Manufacturing Food and drug administration

The EMA has cleared Janssen to make the HIV drug Prezista (darunavir) using a continuous manufacturing (CM) process as well as the previously approved batch method.

The European Medicines Agency (EMA) decision is based on the use of continuous production and real-time release testing, rather than batch production and batch release-testing which was used when Prezista was approved in 2007.

Craig Stoltz, Janssen manufacturing and technical operations spokesman, told us "it's not an all out switch but rather CM was approved as an alternate manufacturing process, meaning we can produce from both batch and CM​."

He declined to give details of the data shared with the EMA, but did say "continuous manufacturing allows us to run the production line only long enough to make the volume of product needed. As a result, we are able to reduce overall inventory, track demand and produce additional supply based on market need​."  

Continuous developments

The approval brings the EMA into line with Swissmedic and the US FDA, which have both cleared the J&J unit to switch from a ‘batch’ approach.

Janssen’s continuous manufacturing line for Prezista is at its facility Gurabo, Puerto Rico.

The firm said: “Effective immediately, Prezista 600 mg tablets manufactured on the CM line at the JSC facility located in Gurabo, Puerto Rico can be used to treat patients in the 28 EU Member States​.”

Wider application

In 2016​, when the US Food and Drug Administration (FDA) became the first regulator to allow Janssen to run a CM Process in parallel to a batch process, the firm told us continuous production reduces testing time from 30 to 10 days and cuts waste by 33%.

Janssen is investigating applications of CM techniques in the development and manufacturing other pharmaceutical products.

Stoltz told us "We are testing continuous manufacturing with other currently approved products. We are not able to provide details of timing for additional filings with regulatory authorities.

"In addition to the CM line at our Gurabo, PR facility, Janssen is currently working to expand the implementation of CM in our Latina, Italy site, as well as for product development at our Beerse, Belgium facilities​."

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