Vaccines, Blood & Biologics
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Innovation and Regulatory Science
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.
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CBER Research Collaborations
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Research Summaries
Age and Gender Differences Seen in Immune System Response to the 2009 H1N1 Pandemic Influenza Virus Discovery of Hepatitis C Blocking Antibodies Suggests Strategies for Improving Treatment and Prevention Keeping Platelets Safe: The Potential Role of Antimicrobial Peptides Universal Influenza Vaccine against H5N1, H3N2, and H1N1 Shown Effective in Pre-Clinical Trials Proof-of-concept Dual Vaccine against both Smallpox and Anthrax Adjuvant Ramps Up Pandemic Flu Vaccines Innovative Strategy Could Speed Approval of Influenza Vaccines FDA’s Contributions to Advancing New Technologies for Developing Safe and Effective Influenza Vaccines (PDF - 52KB)Synonymous (“Silent”) Mutations in Health, Disease, and Personalized Medicine: Review Antibodies From Humans Receiving Investigational Influenza Vaccine Are Effective Against H5N1 (Avian Influenza) and Might Protect Against a Variety of These Viruses Outbreaks of Mumps Apparently Not Caused by New Viruses That Evade Existing Vaccine Study Reports Aluminum in Vaccines Poses Extremely Low Risk to Infants “Swine Flu” Vaccine of 1976 Protected Older Adults from the 2009 H1N1 Pandemic Virus Mutation is enabling some influenza viruses to evade neutralization by previously broadly-active antibodies. Protecting the immunocompromised patient by modeling a potentially fatal smallpox vaccine side effect Novel insurance claims study shows some antibody-containing products pose increased risk of potentially fatal blood clots Babesiosis, a malaria-like disease, may be rising among elderly in U.S. DNA-like Probes (Aptamers) Help Detect Subtle Changes in Three-Dimensional Structure of Therapeutic Proteins The Global Public Health Concern of Leishmaniasis: FDA Scientists Play a Major Role in Development of a Candidate Vaccine to Protect Populations and Blood Supplies FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus Developing Gene Therapy for Cancers Using Virus Vectors Supporting the Development of Mesenchymal Stem Cells as Medical Therapies
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Scientific Posters
An alternative method for preparation of pandemic influenza strain-specific antibody for vaccine potency determination (PDF - 1.2MB)A Candidate Universal Vaccine for Control of Rapidly Emerging, Highly Virulent Influenza Viruses (PDF - 4.3MB)CBER Receives Accreditation for Laboratory Testing of Influenza Vaccines and Evaluation of Blood Donor Screening Kits (PDF - 194KB)Keeping Platelets Safe: Potential Role of Antimicrobial Peptides (PDF - 195KB)Identifying Faster Sterility Tests for Biological Products (PDF - 185KB)A Potential Strategy for Preventing Complications of Hemolytic Diseases and Toxicity of Hemoglobin-Based Oxygen (PDF - 358KB)Developing the "Ultimate Tool" to Ensure Live Viral Vaccine Safety (PDF - 401KB)A Potential Strategy for Successful Treatment and Prevention of Hepatitis C Infection (PDF - 1.8MB)Age and Gender Difference in the Immune System Response to the 2009 H1N1 Pandemic Influenza Virus (PDF - 15.6MB)Advancing Regulatory Science: CBER-Produced Botulinum Toxoids Support Development of Improved Standards for Testing Botulinum Antitoxin Products (PDF - 234KB)CBER Science Supports Vaccine Development and Assays of Vaccine Safety and Efficacy (PDF - 245KB)Insight into How Carbon Nanotubes Cause a Thrombus: Activation of Platelets Through “Store-Operated” Calcium Entry (PDF - 806KB)Evidence for a Link between an Immune Globulin Product and Thrombosis (PDF - 216KB)Babesiosis, a Malaria-Like Infection, Might be Rising Among Elderly in the United States
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