Animal-Free Culture Processfor Manufacture of Viral Vaccines:Process Validationand Regulatory Perspectives

摘要

Several biological reagents of animal origin are currently used as constituents of the culture media for the manufacture of vaccine. Among these, the following additives are the most frequently used:- bovine serum from foetal or young animals- porcine trypsin- human albumin- miscellaneous animal protein hydrolysatesThe use of these components imposes numerous difficulties which have an impact on the safety (presence of adventitious agents, endotoxin), consistency (variable performance in terms of cell growth and product manufacturing) and the cost of production ofbiopharmaceuticals in animal cells.To reduce the risks associated with the use of the serum or trypsin during production, a number of measures have to be considered and combined to ensure the highest guarantee for the absence of adventitious agents [1,2]:(i) selection of the source animals;(ii) thorough testing for adventitious agents;(iii) specific treatment to inactivate or remove the extraneous agents.