ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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A preparation of microbial antigens that provokes an immune response (i.e. the production of antibodies) on injection, thus conferring immunity on the recipient. There are three types of vaccines:

1. Those containing material from a nonvirulent organism that retains its immunogenicity but does not result in infection.

2. Those containing a modified toxin (a toxoid) that has lost its toxic properties but retains its immunogenicity.

3. Those containing live, attenuated organisms (i.e. genetic variants of a virus or bacterium) that are antigenically similar to the original strain but lack virulence.

Recombinant DNA research has allowed the production of new and more specific vaccines. For example, the gene for the B antigen of hepatitis virus has been cloned in E. coli, the protein expressed and a specific anti-B antiserum produced which can be used as a vaccine.


A preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that is administered to produce or artificially increase immunity to a particular disease.


A biologic product generally made from an infectious agent or its components — a virus, bacterium, or other microorganism — that is killed (inactive) or live-attenuated (active, although weakened). Vaccines may also be biochemically synthesized or made through recombinant DNA techniques.

Publication Source: Committees on Human Research


Antigens prepared from modified organisms that elicit immune response (antibody production) to protect a person or animal from a disease agent.

Publication Source: ISPE Baseline® Guide, Vol. 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Publication Date: 2010

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