Vaccines, Blood & Biologics  

Biologics are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology—in contrast to drugs that are chemically synthesized. Biological products may include vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. [1]

Center for Biologics Evaluation and Research (CBER) is an office within the US Food & Drug Administration (FDA) that regulates biological products for human use. [2] Biologics that are used as drugs (i.e. erythropoietin, insulin, therapeutic antibodies) are under the jurisdiction of the Center for Drug Evaluation and Research (CDER). Therapeutic biological products under CDER’s jurisdiction include:[3]

  • Monoclonal antibodies for in-vivo use
  • Proteins intended for therapeutic use, including cytokines, enzymes, and other novel proteins (including therapeutic proteins derived from plants, animals, or microorganisms and recombinant versions of these products)
  • Immunomodulators
  • Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo.

Therapeutic biological products under CBER’s jurisdiction include: [4]

  • Cellular products, including products composed of human, bacterial, or animal cells, or from physical parts of those cells
  • Gene therapy products
  • Vaccines
  • Allergenic extracts used to diagnose and treat allergic diseases and allergen patch tests
  • Antitoxins, antivenins, and venoms
  • Blood, blood components, plasma derived products—including recombinant and transgenic versions of plasma derivatives (i.e., clotting factors), blood substitutes, plasma volume expanders, human or animal polyclonal antibody preparations (including radiolabeled or conjugated forms), and certain fibrinolytics (plasma-derived plasmin, red cell reagents, etc.)
  • Human cells, tissues and cellular and tissue-based products (HCT/P’s). This category includes HCT/P’s containing cells that have been harvested following in vivo administration of a CDER-regulated growth factor, cytokine, or monoclonal antibody,2 as well as HCT/P’s requiring ex vivo manipulation.

CBER is responsible for approving requests for permission to market a biologic product, or the Biologics License Application, which allows for the manufacture and distribution of the biologic. [5]

Updated by Peter Matos, December 2023