Techniques de Contrôle et Processus de Fabrication d’un Biomédicament Ce Cours est destiné aux étudiants de 01 année Master Spécialité Biotechnologie et Pathologie Moléculaire

Abstract

A biopharmaceutical meets the definition of a drug, but it also possesses some additional characteristics, such as its immunogenicity. This can lead to differences in the final product (activity or stability). We will first distinguish, using the Public Health Code, that a chemical drug is defined as "any substance or composition presented as having curative or preventive properties with regard to human or animal diseases, as well as any product that can be administered to humans or animals for the purpose of establishing a medical diagnosis or restoring, correcting, or modifying their organic functions," according to Article L.5111-1 of the Public Health Code. To illustrate this definition, we can give the example of acetylsalicylic acid, better known as Aspirin, which is used for its antipyretic, analgesic, antiplatelet, and, at high doses, anti-inflammatory properties.