Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Burridge: Perceived barriers to continuous manufacturing have been falling one by one. ICH Q13 facilitates adoption of continuous manufacturing. By providing common language and a framework of fundamentals of a continuous manufacturing. I see as an accelerator, rather than an endpoint, the evolution of pharmaceutical quality over the last several decades. With adoption of risk based approaches, process analytical Technology and Quality by design have set the stage for adoption of continuous manufacturing. The concepts of process dynamics and system integration from multiple connected human operations are newer for the pharmaceutical industry. However, while newer to the pharmaceutical industry, continuous manufacturing has been the norm and other industries, such as petroleum refining for over 100 years. The FDA encourages industry to adopt and implement continuous manufacturing. The FDA Emerging Technology Team, created in 2014 allows for additional engagement and interaction with the agency to help industry adopt new technologies such as continuous manufacturing. There are about 14 FDA approved drugs that include continuous manufacturing elements. The first drug approved with continuous manufacturing elements was in 2015, followed by the first approval for switch from batch to continuous manufacturing in 2016. The first biotechnology or protein therapeutic drug with continuous manufacturing LMS was approved in 2020. 2022 saw the publication of ICH Q13 and the internationally harmonized guidance on continuous manufacturing. That same year, there was an FDA publication, which showed that the approval times for products with continuous manufacturing elements was actually faster than that for similar products using batch manufacturing. In summary, guidance from the FDA and the ICH had been published. There have been approvals for both small and large molecule drugs. There are FDA programs such as the emergent technology program designed to foster early engagement and collaboration. And certainly not least, the analysis has shown that approval timelines for continuous manufacturing are not longer than those for similar products produced with the batch operation.