FDA regulates pharmaceutical products to ensure a continuous supply of high-quality products in the United States. In regulating the pharmaceutical manufacturing sector, FDA realizes the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics. To help achieve this vision, FDA encourages development and adoption of advanced manufacturing technologies to modernize pharmaceutical manufacturing. Such a modernization effort aims to result in a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the biologic products manufactured will provide the expected clinical performance.
While the development of advanced technology is critical to modernizing pharmaceutical manufacturing and improving quality, FDA also recognizes that the implementation of advanced technology could present challenges to both industry and FDA. By the very nature of an approach being new or innovative in pharmaceutical industry, a limited knowledge and experiential base about the technology may exist.
The Center for Biologics Evaluation and Research (CBER) has established the CBER Advanced Technologies Team (CATT) to provide an interactive mechanism to promote dialogue, education, and input between CBER and prospective innovators/developers of advanced manufacturing and testing technologies. The aim of CATT is to facilitate discussions to promote the implementation of these technologies in the development of CBER-regulated biologic products. Through this program, interested parties have access to early interactions with CBER prior to filing a regulatory submission. Details on the CATT program and instructions for submitting inquiries can be found at the CATT portal website.
CBER has awarded several grants and contracts to support research projects to study and recommend improvements for the advanced manufacturing of biological products, including the investigation and development of innovative monitoring and control techniques. The funded research addresses knowledge and experience gaps identified for emerging manufacturing technologies and support the development and adoption of such technologies in the biological product sector. The agency will continue to support efforts to develop the standards and policies needed to foster the effective and efficient development and adoption of new manufacturing platforms. Additional information on extramural funding can be found at the CBER Advanced Technologies Program Extramural Research Funding website.