Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

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• 2nd and 3rd floors (from 1960 to 1967) (Rooms 318, 308, 332, 207, 216, 316, 330, 222, 214, 207); most of 3rd floor (if looking at the front elevation of Building 29) 

Organizational Changes in CBER

In 1988, a new research division was established within CBER, the Division of Cytokine Biology. Cytokines are proteins that have multiple cellular functions, including effects on the immune system, antiviral activities, and the ability to differentiate between cells. Cytokine biology has the potential to further the development and review of therapies for diseases like AIDS and cancer.

In March 1989, CBER had six divisions, and each division had two to seven laboratories within it, totaling to 29 laboratories related to biologics regulation at the FDA. Some laboratories had sections within them, much like DBS did in the 1960s.

Division of Product Quality Control

Research in this division focuses on improving existing quality control tests for biologics by finding ways to improve animal tests or to switch them to in vitro (test tube or cell culture) tests. The biological testing laboratory is within this division, and it has two sections: the reference reagents section and the animal testing and quality assurance section. The reference reagents section establishes the U.S. Reference, or standard preparation used by the FDA and manufacturers when performing official tests required for biologics. The animal testing and quality assurance section is responsibility for testing the potency and sterility of biological products and does safety tests on vaccines.

Division of Blood and Blood Products

The Division of Blood and Blood Products performs research on the preparation, preservation, and safety of blood and blood products, and methods for testing the safety, purity, potency and effectiveness of these products when used therapeutically. There are seven labs in this division: cell biology, transplantation biology, blood bank practices, retrovirology, hepatitis, plasma derivatives, and cell components. 

Division of Virology

Vaccine testing and research is done by this division, including their four labs: DNA virus research, respiratory virus, pediatric diseases, and retrovirus. 

Division of Cytokine Biology

This was the newest division of CBER in 1989, having only been formed in 1988. It was an outgrowth of the Division of Virology. Cytokines are proteins that have multiple cellular functions, including effects on the immune system, antiviral activities, and the ability to differentiate between cells. The division is responsible for conducting regulatory review and research on biological response modifier agents (medical treatments derived from substances naturally found in the body), which may hold promising treatments for AIDS, cancers, and infectious diseases. Laboratories under the Division of Cytokine Biology include cellular immunology, cell biology, and molecular immunology. 

Division of Biochemistry and Biophysics 

This division is an interdisciplinary group who studies molecular and cell biology, pharmacology and toxicology, biochemistry and biophysics, and combines basic science with regulatory activity. There are seven labs in this division: molecular immunology, biochemistry, analytical chemistry, biophysics, cellular and molecular biology, molecular pharmacology, and chemical biology. 

Division of Bacterial Products

This division has seven labs within it, including pertussis, allergenic products, bacterial toxins, bacterial polysaccharides, mycobacteria and cellular immunology, mycoplasma, and cellular physiology.