Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Industry (Biologics)

Industry (Biologics)

                        CBER Advanced Technologies Program
          Manufacturers Assistance and Technical Training Branch (MATTB)


                        Coronavirus (COVID-19) | CBER-Regulated Biologics Home
          Vaccines, Blood & Biologics
          Resources for You (Biologics)
          Industry (Biologics)
          CBER Advanced Technologies ProgramIndustry (Biologics) CBER Advanced Technologies Program
  
  	
    Share
    Post
    Linkedin

    Email
    PrintFDA 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 **C**BER **A**dvanced **T**echnologies **T**eam (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.

                                                                                  Content current as of:
      09/29/2021
              
              
Regulated Product(s)
		 BiologicsIndustry (Biologics)

          
                        CBER Advanced Technologies Program
          Manufacturers Assistance and Technical Training Branch (MATTB)


                        Coronavirus (COVID-19) | CBER-Regulated Biologics
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop