Vaccine in USA
Draft Guidance for Industry
Characterisation of
MVSS/MCB
Working Cell Bank End of production bank MVSS TestingMaster Cell Bank
Production Control
Cell Testing
Characterisation of
Virus Bulk Harvests
Final Product Testing...
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Vaccine in USA
Draft Guidance for Industry
Characterisation of
MVSS/MCB
Working Cell Bank End of production bank MVSS TestingMaster Cell Bank
Production Control
Cell Testing
Characterisation of
Virus Bulk Harvests
Final Product Testing
Observation/Morphology•
in vitro• adventitious virus test
in vivo• adventitious virus test
Haemadsorbtion•
Mycoplasma/Spiroplasma•
Sterility•
Species specific viruses•
Mycobacteria•
RT Assay•
Bovine viruses following•
methods outlined by 9CFR
113.
53 and 113.
47
Porcine viruses following•
methods outlined by 9CFR
113.
53 and 113.
47
Sterility•
Mycoplasma/ Spiroplasma•
Mycobacterium•
Appearance•
Identity•
Potency/Infectious titre•
RT Assay•
14 Day• in vitro – MRC-5,
Vero and cells of same
species and tissue type as
the production cells
in vivo• assay in adult
and suckling mice and
embryonated chickens eggs
Bovine viruses following•
methods outlined by 9CFR
113.
53 and 113.
47
Porcine viruses following•
methods outlined by 9CFR
113.
5
Less
