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

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

Highlights ► Up-to-date regulatory requirements for cell substrate characterisation. ► Comprehensive information from different regulatory frameworks (WHO, EU/EP, USA/FDA, USP and ICH). ► Focus on the manufacture of live attenuated viral vaccines and its problems associated with downstream purificat...

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Veröffentlicht in:Vaccine 2012-04, Vol.30 (17), p.2715-2727
Hauptverfasser: Hess, Ralf D, Weber, Friedemann, Watson, Keith, Schmitt, Siegfried
Format: Artikel
Sprache:eng
Schlagworte:
Allergy and Immunology
Animals
Biosafety
Cell bank characterisation
Cell culture
Cell Culture Techniques
Cell Line
Cell substrates
Chinese hamsters
compliance
Conferences
developed countries
Developing countries
dogs
Eggs
Embryo fibroblasts
fibroblasts
Food and Drug Administration
Good Manufacturing Practice
hens
Humans
Infectious diseases
Influenza A
Influenza A virus
kidneys
Live attenuated virus vaccines
manufacturing
monkeys
Mortality
Oncogenicity
Orthomyxoviridae
pandemic
pandemics
pH effects
Pharmaceutical industry
Pharmaceuticals
Regulations
risk
Rodents
safety testing
swine influenza
Tumourigenicity
Vaccination - legislation & jurisprudence
Vaccines
Vaccines - adverse effects
Vaccines - standards
Vero cells
viral vaccines
World Health Organization
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Beschreibung
Zusammenfassung:Highlights ► Up-to-date regulatory requirements for cell substrate characterisation. ► Comprehensive information from different regulatory frameworks (WHO, EU/EP, USA/FDA, USP and ICH). ► Focus on the manufacture of live attenuated viral vaccines and its problems associated with downstream purification. ► Focus on major concerns such as tumourigenicity and oncogenicity of PCC. ► Arbitrary risk based classification of cell substrates for the manufacture of vaccines for human use.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2012.02.015