FDA officials tout progress and achievements in advanced manufacturing

Regulatory NewsRegulatory News | 15 October 2021 |  By 

FDA's Patrizia Cavazzoni, Michael Kopcha

The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).
In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FDA’s Center for Drug Evaluation and Research (CDER) and CDER director Patrizia Cavazzoni in a 13 October FDA Voices article.
The article coincides with FDA’s release of the long-expected International Council for Harmonisation (ICH) Q13 guidance on continuous manufacturing issued on 14 October. The agency set a 13 December 2021 deadline to comment on the draft guidance, which currently remains in ICH format.
FDA’s release of the guidance follows ICH’s release of Q13 guideline on 27 July. (RELATED: ICH releases widely anticipated guidance on continuous manufacturing, Regulatory Focus 27 July 2021)
Agency officials have been encouraging the adoption of continuous manufacturing for at least ten years. This mode of manufacturing “can help domestic companies operate with lower costs and fewer quality defects in smaller facilities, improving the global competitiveness of US manufacturing,” note Kopcha and Cavazzoni.
The agency has thus far accepted over 100 advanced manufacturing proposals in its ETP and has held more than 100 meetings with industry on their plans to use advanced manufacturing in regulatory submissions. The authors observed that interest has grown to the point that the agency is setting up “ETP 2.0” to keep up with demand.
“Under the enhanced ETP, more FDA staff will be trained on new technologies to improve our ability to evaluate them,” wrote the FDA officials
The number of approved continuous manufacturing applications has also steadily increased from one approval in 2015 to 10 approvals by July of this year. The 2015 continuous manufacturing approval was for Vertex’s cystic fibrosis drug Orkambi (lumacaftor/ivafactor) (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon, Regulatory Focus 15 July 2021; FDA Allows First Switch From Batch to Continuous Manufacturing, Regulatory Focus, 12 April 2016)
Patients with cystic fibrosis, HIV, breast cancer, leukemia and asthma are already seeing benefit from medicines produced though advanced manufacturing technologies, according to the FDA Voices piece.
Congressional funding for FDA’s advanced manufacturing initiatives has allowed the agency to establish “numerous initiatives,” including close to 60 research projects to “better understand the science of advanced manufacturing,” according to Kopcha and Cavazzoni.
Among the 24 bipartisan health- and cybersecurity-related bills advanced in July by the House Energy and Commerce Committee was an initiativeaimed at promoting advanced and continuous manufacturing for pharmaceuticals. (RELATED:  House committee advances bills on advanced manufacturing, opioids and more, Regulatory Focus 21 July 2021)
The conclusions drawn from the research helped inform FDA’s draft guidance on continuous manufacturing, issued in February 2019. The draft guidance laid out quality considerations for continuous manufacturing for small molecule products.
FDA is also reviewing a National Academy of Sciences, Engineering and Medicine report to plan for future submissions in advanced manufacturing. The report, issued in March, projects growth in end-to-end continuous manufacturing; portable and modular distributed manufacturing platforms, also called “pharmacy-on-demand;” and artificial intelligence or advanced modeling approaches in manufacturing.
The report also addresses “knowledge and experience gaps” in the regulatory framework for or advanced manufacturing.  
To “maintain the momentum of advanced manufacturing,” FDA established the Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals in June 2021, noted the authors. The center aims to coordinate and to help collaborate science and policy activities related to advanced manufacturing.
FDA article


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