Glossary for the most common terms from the WHO guidelines
Here you can find the terms and abbreviations referred to in this course. It is recommended to have it open and accessible while completing the course.
For easier access to the glossary at any point, keep it open on a side tab while going through the sessions.
Active Pharmaceutical Ingredient
Active Pharmaceutical Ingredient Starting Material
The active ingredient in a vaccine against which the immune response is induced. Antigens may be: (a) live attenuated or inactivated preparations of bacteria, viruses or parasites; (b) crude cellular fractions or purified antigens, including recombinant proteins (that is, those derived from recombinant DNA expressed in a host cell); (c) polysaccharides and conjugates formed by covalent linkage of polysaccharides to components such as mutated or inactivated proteins and/or toxoids; (d) synthetic antigens; (e) polynucleotides (such as plasmid DNA vaccines); or (f) living vectored cells expressing specific heterologous antigens. Also referred to as “immunogen” in other documents.
Also used to describe (a) a component that may undergo chemical change or processing before it becomes the antigen or active ingredient used to formulate the final product (also referred to as an “intermediate” in other documents); or (b) an active ingredient present in an unmodified form in the final product (also referred to as “drug substance” or “active substance” in other documents). For example, in this document the term “antigen” applies, in the case of a polysaccharide conjugated vaccine, to the polysaccharide intermediate as well as to the conjugated polysaccharide that will not undergo further modification prior to formulation.