Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

摘要: In the development of novel substrates used for production human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like porcine Influenza A virus (H1N1) pandemic necessitated availability unprecedented amounts vaccines. addition, high demand industrialised countries also paralleled by a steep increase developing countries. The manufacturing capability viral produced embryonated hen eggs conventional/classical cell substrates, such as chicken embryo fibroblasts, now reached its capacity limit. This constraint may be overcome utilising other recognised Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) an alternative, introduce new avian origin. Using prove to highly replication-proficient way producing live viruses. Despite some advantages, pose small residual risk humans since them are known tumourigenic immunosuppressed animals. However, this should considered acceptable regulators. Safety testing requirements manufacture is mandated published guidance from organisations World Health Organization (WHO), United States Food Drug Administration (FDA), European Medicines Agency (EMA) International Conferences on Harmonization Technical Requirements Registration Pharmaceuticals Human use (ICH) well laid down compendial monographs (Ph. Eur. USP). paper considers contained these regulatory documents. safety challenges almost arbitrary risk-based classification together with compliance GCCP (Good Cell Culture Practice) discussed. Even though tremendous last few years, reflected mainly revisions updates documents, still no consensus between regulators nor harmonisation documents monographs.