Downstream processing of viral vectors and vaccines.

摘要

Viral vectors and viral vaccines more and more play an important role in current medical approaches. Gene vectors like adenoviruses, adeno-associated viruses or retroviruses are the vehicles being developed for delivering genetic material to the target cell in gene therapy. Viral vaccines, like attenuated or inactivated rabies virus, influenza virus or hepatitis virus vaccines, are powerful tools to limit the number of serious viral infections and pandemics. Higher safety demands, that is, reduction of side effects, by regulatory authorities like Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMEA), nowadays force developers as well as manufacturers to improve their production and purification processes for viral vectors and vaccines. Like for influenza viral vaccines, manufacturers begin to switch from egg cultivation to mammalian cell culture systems. Also within the purification procedure, a clear trend from classical purification methods like sucrose gradient centrifugation towards more sophisticated techniques like tangential flow filtration and liquid chromatography can be observed.