Laboratories

When the Division of Biologics Standards (DBS) was established in 1955, this centralized the biologics regulatory function at the National Institutes of Health (NIH) into one division rather than spread across multiple laboratories and institutes. However, for the first five years the staff was still spread amongst multiple buildings on the NIH campus. In 1960, Building 29 was completed and the staff was consolidated into one space. During the early 1960s the laboratories and the sections within them were still being finalized and organized based on the growing needs and demands of vaccine production and other biologics regulations. By 1968, the DBS had the below seven laboratories.

When the DBS was administratively transferred to the Food and Drug Administration (FDA) Bureau of Biologics in 1972, many of these labs remained the same, but under the title of Division instead of Laboratory. During the 1980s there was significant reorganization, and many divisions were combined, abandoned, or changed names entirely. 

Laboratory of Bacterial Products

• 4th Floor (Rooms 420, 429, 431, 429A, 432, 418, 406, 416); left side of 4th floor (if looking at the front elevation of Building 29) 

Laboratory of Biophysics and Biochemistry

• Rooms 305 and 306; right side of 3rd floor (if looking at the front elevation of Building 29)

Laboratory of Blood and Blood Products

• 1st floor (from 1960 to 1967) (Rooms 112, 107, 114, 111, 104, 100, 404, 400) and then the 2nd and 3rd floors (after 1967) (Rooms 318, 324, 326, 311, 225, 330, 219, 306); right side of 1st floor, then left side of 2nd and third floors (if looking at the front elevation of Building 29) 

Laboratory of Control Activities

• 4th floor (from 1960 to 1967) (Rooms 400, 405, 416, 401, 402, 403); right side of 4th floor (if looking at the front elevation of Building 29)  

Laboratory of Pathology

• Rooms 512 and 516; middle left side of 5th floor (if looking at the front elevation of Building 29) 

Laboratory of Viral Immunology

• 2nd floor (from 1960 to 1967) (Rooms 212A, 229, 200, 208, 209, 230, 221, 311); most of 2nd floor (if looking at the front elevation of Building 29) 

Laboratory of Virology and Rickettsiology

• 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 (listed below), 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. Many of these divisions are similar in their research and regulation roles to the 1960s DBS laboratories listed above.

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. 

Allergenic Products 

Allergenic investigations by the FDA Bureau of Biologics in 1978 focused on standardized in vitro and in vivo assays of allergenic potency. The former tests under development included radial immunodiffusion, isoelectric focusing, and allergen coupling compared to radioactive or enzyme-labeled antibody. The in vivo assays under study were based on the skin tests used in allergic patients as well as the immunogenicity of allergenic extracts following their use in the immunotherapy of allergic disease.

Mycoplasma

By the early 1980s the FDA Bureau of Biologics had a laboratory on mycoplasma, but scientists had been investigating mycoplasmas since before the DBS moved into Building 29 in 1960. Mycoplasmas are single-celled bacteria lacking a cell wall and are able to penetrate other cells; they constituted a challenging source of contamination of cell cultures. A DBS regulation in 1960 required manufacturers to test for mycoplasmas in human viral products that relied on cell cultures.  As mycoplasma tests advanced over the years, the testing rules changed accordingly. With the emergence of hybridoma technology to generate biological products (in which a target antigen is injected into a mouse, a resulting antibody-producing cell is harvested from the spleen, and the splenic cell fused with a tumor cell to produce the desired antibody), mycoplasmas found their way into the new products from this technology, such as monoclonal antibodies. The Bureau of Biologics’ rulemaking and research interests by the 1980s thus had shifted to controlling mycoplasma contamination of the products developed from this newer approach to biologics production

When the biologics regulation function emerged after the many organizational changes at the FDA as CBER, it then included an Office of Establishment Licensing, an Office of Blood Research and Review, an Office of Vaccine Research and Review, an Office of Therapeutic Research and Reviews, and the Office of Compliance.