BioOutsource Ltd • Units 3/4 Technology Terrace • Todd Campus • West of Scotland Science Park • Glasgow • G20 0XA
tel: +44 (0)141 946 4222 • email: info@biooutsource.
com • web: www.
biooutsource.
com
Vaccine in Europe
European Pharmacopiea...
More
BioOutsource Ltd • Units 3/4 Technology Terrace • Todd Campus • West of Scotland Science Park • Glasgow • G20 0XA
tel: +44 (0)141 946 4222 • email: info@biooutsource.
com • web: www.
biooutsource.
com
Vaccine in Europe
European Pharmacopiea
Characterisation
of MVSS/MCB
Production
Control Cell Testing
Observation – light•
microscopy
Haemagglutination test on•
25% of cultures
14 Day• in vitro – MRC-5,
Vero
Characterisation of
Virus Bulk Harvests
Sterility (10mL)•
Mycoplasma (10mL)•
14 Day• in vitro – MRC-5,
Vero (50mL)
in vivo• egg assay as
appropriate
Final Product Testing
pH (2.
2.
3).
• Liquid vaccines, after reconstitution where
applicable, comply with the limits for pH approved for
the particular preparation.
• Adjuvant.
If the vaccine contains an adjuvant, the
amount is determined and shown to be within
acceptable limits with respect to the expected amount
(see also the tests for aluminium and calcium below).
• Aluminium (2.
5.
13): maximum 1.
25 mg of
aluminium (Al) p
Less
