Importance to FDA
Advanced manufacturing is a collective term for innovatively applied or new medical product manufacturing technologies and processes that can improve quality, enhance efficiency, address shortages of medical products, or speed time-to-market. Advanced production techniques often include one or more of the following characteristics:
- integrate novel technological approaches;
- use established techniques in a new or innovative way; or
- apply production methods in a new domain where there are no defined best practices or experiences.
The types of advanced manufacturing being applied to FDA-regulated medical products include but are not limited to the following:
- Additive manufacturing (also known as 3D printing) increases manufacturing flexibility and personalization.
- Process intensification integrates, combines, or enhances steps in complex processes, making them more efficient, more reliable, and often shrinks the required space and resource requirements. There are examples across all medical product areas which include continuous manufacturing and modularization.
- Advanced manufacturing can apply smart manufacturing concepts that use automation, digitization, and artificial intelligence to streamline production methods, collect more process control data, and ultimately use a smart algorithm to adaptively control or make decisions about production or release. Advanced and smart manufacturing methods can be used across all medical products.
- Due to a combination of increased computing power, improved cross-sectional imaging, and faster, more reliable additive manufacturing machines, a new point-of-care manufacturing medical specialty has emerged as evidenced by a significant increase in the number of hospital systems across the U.S. that have deployed various sizes of manufacturing capabilities. Also, advances in the intensification, and modularization of manufacturing platforms and facilities enable new opportunities for point-of-care manufacturing of therapeutics.
FDA supports and conducts research to encourage further development and adoption of advanced manufacturing technologies and evaluates products manufactured using these technologies, addressing several significant challenges:
- Rapidly scale manufacturing capabilities to respond more quickly to emerging threats and public health emergencies (e.g., COVID-19).
- Develop new approaches to facilitate rapid vaccine production, 3D printing, continuous manufacturing, and improved manufacturing approaches for a variety of cell-based and gene therapies (e.g., stem cells and chimeric antigen receptor T-cells, a type of immune system cell).
- Increase supply chain resilience to disruption by creating a flexible and agile network of small cost-efficient manufacturing sites that can pivot quickly to provide reserve capacity.
- Accelerate development of novel or patient-focused medical products by improving the robustness and cost-efficiency of manufacturing processes. For example, using 3D printing technology to develop standards for personalized drug-device combination hormone delivery systems (e.g., intravaginal rings) for menopausal women.
- Identify parameters influencing the production of stem cell products and gene therapy vectors using new, advanced manufacturing technologies.
- Accelerate availability of emerging therapies by enabling the rapid scale-up of processes for manufacturing and standards development, including for cell and gene therapies, supporting goals of the 21st Century Cures Act (Cures Act, Public Law 114-225).
- Provide new tools to address medical product shortages often attributed to outdated manufacturing and control technologies and a lack of effective quality management systems.
- In fiscal years 2018 and 2019, FDA awarded grants under the Cures Act authority to fund extramural research fostering development of new technology in support of advanced manufacturing.
- Existing regulatory policies and recommended practices, standards, and industry-wide technical reports have been based on drug batch manufacturing processes. However, new technologies are focused on making drugs in a continuous process without isolated steps. In one of these studies, research is ongoing to better understand how to remove viral particles during the manufacture of protein biological products using the new continuous manufacturing (CM) paradigms. ICH Q5A principles need to be adapted to developing small-scale studies on CM's integrated continuous process steps, so FDA is investigating a commercially available continuous chromatography system and has developed a potential representative small-scale model for continuous viral filtration.
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