News about GMP/cGMP


FDA seeks input on “Continuous Manufacturing”

On September 11, 2017, Michael Kopcha, Ph.D., R.Ph. and FDA’s director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), announced the opening of a public docket to seek input from experts in areas of science, technology and best practices concerning “Continuous Manufacturing”. To establish common guiding principles to this new technology shall help to push this production method forward.

“As with any new technology, implementing CM presents challenges, such as the initial cost of investing in new equipment. However, the CM production method offers clear benefits for both patients and industry. CM can shorten production times and improve the efficiency of the manufacturing process”, Michael Kopacha says and adds “CM also allows for more nimble testing and control that can help reduce the likelihood of manufacturing failures.”

For decades, most drugs have been manufactured using the “batch technology”. Now a new technology which enables a much faster production through an uninterrupted process is on its way. By eliminating breaks between steps human errors during starts and stops in the conventional batch process can be reduced. Continuous Manufacturing is said to be more reliable, safer and faster. Even manufacturing costs can be cut while the product quality is maintained. All in all that is a powerful combination.

Recognizing these potential benefits, the FDA plans to provide regulatory principals and expectations regarding the use of CM. The 21st Century Cures Act of December 2016, authorized grants to support studying CM and recommending improvements to the process of continuous manufacturing of drugs and biological products. FDA encourages adoption of this technology by engaging with firms interested in using CM. FDA’s Emerging Technology Team (ETT) assists in implementing CM, for manufacturing both new and existing drugs. FDA is also working to take the topic to a global level by engaging foreign regulatory counterparts regarding the development of clear regulatory standards.

Two approvals for a manufacturer’s change in production method from “batch” to continuous manufacturing have already been given by the FDA to Vertex in 2015 and Janssen Products in 2016. In June 2017, the European Medicines Agency (EMA) also gave their approval for the Janssen Drug made via continuous manufacturing. The production of “Prezista” is currently taking place on a continuous production line in Gurabo, Puerto Rico. The product is now available for patients in 28 EU Member States. Swissmedic also gave their approval for use in Switzerland. Janssen Product is already developing other projects and other drug manufacturers will follow suit. It seems to be high time, to get a regulatory approach to this new technology off the ground.

The public docket is open for comment until September 21.


FDA Voice