[Specific aspects of vaccine manufacturing].
The industrial development of vaccine manufacturing expanded during the second half of the 20th century. Vaccines are medicines which target healthy people. The active principles of vaccines arise from live organisms and can be distinguished from standard pharmaceutical compounds by their extreme complexity. The properties of vaccines depend mainly of the manufacturing process and it common to state that "the process makes the product". The manufacturing is done in confined rooms because of the pathogenic characters of the organisms involved. Raw materials are subjected to rigorous controls to guarantee the integrity of products towards non-conventional agents like prion. The vaccine industry is characterized by the length of the manufacturing cycle. The complexity of the products implies heavy quality controls, which represent 75% of the total duration of the manufacture cycle. As a key element of public health, the vaccine production can be subjected to variations and adaptations, in particular in the context of outbreaks or bioterrorism. The vaccine industry must integrate the regulatory requirements, which are more and more pressing. The spectacular development of the quality assurance and quality control departments these last 15 years testifies to this evolution.
Speck
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Laboratoire de fermentation et développement des procédés, Sanofi Pasteur, campus Mérieux, Bâtiment A2, Marcy-l'Etoile, France. denis.speck@sanofipasteur.com
D000918:Antibody Specificity; D023482:Bioterrorism; D004345:Drug Industry / Q000191:economics / Q000639:trends*; D006801:Humans; D011634:Public Health; D011786:Quality Control; D014612:Vaccines / Q000191:economics / Q000592:standards
D014612:Vaccines