Drug discovery Online published an article about the most important steps and mistakes the pharmaceutical industry can make when they want to switch from batch to continuous production of drugs.
The article starts with explaining the main concerns industry has when switching from batch to continuous production. For newly developed drugs, the pharmaceutical industry fears that the manufacturing process is not in accordance with the Good Manufacturing Practice (GMP) regulations and hence the product will not be approved by the FDA. Secondly, for products that have been approved on the market, they fear that changing the production from batch to continuous is not in compliance with FDA regulations and the FDA would halt manufacturing or seize the product until compliance is achieved. These are legitimate concerns but they should not become reality because the FDA created an Emerging Technology Team (ETT) to help industry with the transition from batch to continuous production. This ETT released a guidance document “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base” as another resource to help with this transition. Also they formulated the following steps which help manufacturers in their journey:
- Review the information provided by the FDA regarding continuous manufacturing
- Initiate a dialogue with the FDA about the emerging technology
- Seek a vendor that not just designs and develops the process but also continue to support the new manufacturing approach after it has been approved by the FDA
Furthermore, there are success stories that continuous production works. The Cystic fibrosis drug Orkambi (Vertex) and the HIV drug Prezista (Janssen’s). The article concludes that the biggest mistake companies can make is not to use the tools and resources the FDA provides. In conclusion, continuous production can become a success story and continuous flow reactors, as the ones researched within the SIM2 research line Process Intensification and in the COSMIC project, have a future!
The full article can be found here.