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, the Center for Biologics Evaluation and Research (CBER) encourages the development and adoption of advanced technologies to modernize biopharmaceutical 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 technologies is critical to modernizing biopharmaceutical manufacturing and improving quality and patient access, CBER also recognizes that the implementation of advanced technologies could present challenges to both industry and CBER. By the very nature of an approach being new or innovative in the biopharmaceutical industry, a limited knowledge and experiential base about the technology may exist.
CBER has established the CBER Advanced Technologies Team (CATT) to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies that are intended to be implemented in CBER-regulated products. As part of this remit, the CATT will facilitate responses to inquiries from developers of these innovative technologies. Through this inquiry program, interested parties have access to early interactions with CBER prior to filing a regulatory submission. Details on this program and instructions for submitting inquiries can be found here.
CBER has awarded several grants 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 and testing 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.