Any substance or mixture of substances intended to be used in the manufacture of adrug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
A chemical or biological substance that enhances the immune response against an antigen.
'Advanced therapy medicinal product' means any of the following medicinal products for human use: a gene therapy medicinal product, a somatic cell therapy medicinal product, a tissue engineered product.
Proteins produced by the B-lymphocytes that bind to specific antigens. Antibodies may be divided into 2 main types based on key differences in their method of manufacture: Monoclonal antibodies (MAb) – homogenous antibody population obtained from a single clone of lymphocytes or by recombinant technology and which bind to a single epitope.
Polyclonal antibodies – derived from a range of lymphocyte clones, produced in human and animals in response to the epitopes on most ‘non-self’ molecules.