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                Science & Research (Biologics)

Science & Research (Biologics)

                        


                        Biologics Research Projects Home
          Vaccines, Blood & Biologics
          Science & Research (Biologics)
          Innovation and Regulatory ScienceScience & Research (Biologics) Innovation and Regulatory Science
  
  	
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    PrintImage of a DNA analysis highlighting the molecular structure of a DNA strand.

CBER plays a critical role in the development of biological products that are at the cutting edge of 21st century medicine.

The center regulates preventive and therapeutic vaccines, blood and blood products, and cell, tissue, and gene therapies. Therefore, its research focuses on creating new knowledge in the fields of diagnostic and therapeutic product innovations and the regulatory science needed to ensure those products are safe, effective, and available to the public.

CBER scientists facilitate the development of new and promising biological products and technologies by increasing the understanding of existing products through mission-related research that advances regulatory science.  For example, CBER scientists are actively engaged in developing in vitro (“test-tube”) tests and animal models used to study new therapies and product testing methods, assays, and standards. This work supports the development of CBER-regulated products by enabling the development of manufacturing methods and providing tools to assess product safety, efficacy and manufacturing consistency.  CBER scientists also evaluate potential methods for improving ongoing monitoring of the safety of products that CBER has approved for use.

This web site provides both summaries of recently published research conducted by CBER scientists, posters developed to highlight some of this work, and examples of CBER research collaborations with other agencies, academic institutions, private organizations, and industry.  These web pages will keep you informed of current research being done at CBER that is helping to bring safe and effective products to the public.

Research Summaries and Scientific Posters older than 2 years are available on FDA Archive

Research Summaries

A Method for Detection of SARS-CoV-2 RNA in Healthy Human Stool: A Validation Study
	Study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design
	Synonymous mutation increases in vitro production and activity of enzyme that reduces blood clotting
	Determining susceptibility of influenza A viruses to first-line immune response by pulmonary surfactant protein D (SP-D)
	Universal test for assessing potency of inactivated poliovirus vaccines could facilitate their global production and availability
	FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions
	Influenza candidate vaccine viruses improved by amino acid substitution in hemagglutinin
	TCPro simulates immune system response to biotherapeutic drugs
	FDA identifies biomarker for immune response to FVIII products used to treat hemophilia A
	Luciferase Immunoprecipitation System (LIPS) assay is a rapid, simple, and sensitive test to detect antibody response to respiratory syncytial virus
	Cell analysis technique identifies subpopulations of stimulated mesenchymal stromal cells with in vitro immunosuppressive activity
	FDA scientists discover key chemical steps in formation of microparticles carrying abnormal hemoglobin in sickle cell disease
	Malaria gene activity findings could form basis of improved test for monitoring disease spread
	Universal influenza vaccine candidate reduces transmission of virus best when given nasally in mice
	High replication rate of induced pluripotent stems cells appears to contribute to breaks in DNA
	FDA model suggests that a hepatitis C vaccine could reduce transmission of the virus among injecting drug users
	FDA comparison of characteristics of hemoglobin-based oxygen carriers could guide development of safe and effective artificial blood products
	Maternal vaccination with pertussis vaccine containing only one immunity-stimulating component provides protection against disease in baboon model
	FDA research to improve technique for studying multipotent stromal cell morphology
	Results of FDA study supports development of high throughput sequencing for viral safety evaluation of biologic materials
	FDA develops a novel biomarker based test that improves ability to identify asymptomatic carriers of malaria
	FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus
	High-dose influenza vaccine appears better than standard-dose vaccines in preventing deaths from A(H3N2) influenza among older adultsScientific Posters

Microparticles from sickle cell disease rbcs
	Novel Machine Learning Technique Identifies Populations of Stimulated Mesenchymal Stromal Cells with Immunosuppressive Activity
	Supporting accurate interpretation of microfluidic system analysis of multipotent stromal cell morphology
	Development of an assay to predict the capacity of mesenchymal stromal cells to suppress immune system activity
	Evidence for a Link between an Immune Globulin Product and Thrombosis
	Studies of morphological "signatures" might improve characterization of mesenchymal stem cells for use in tissue regeneration
	Translating complex clinical trial and post-market safety data into visual storiesCBER Research Collaborations

The Role of CBER in the Success against Epidemic Meningitis in Africa - MenAfriVac

                                                                                  Content current as of:
      10/26/2022
              
              
Regulated Product(s)
		 BiologicsScience & Research (Biologics)

          
                        


                        Biologics Research Projects
 
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