Page 155 - Pharmaceutics IV (02-06-01305)

Tissues and fluids are examined for extraneous viruses.
The control tissue is incubated for 10-14 days after the
virus Is harvested from the production tissue & further
search is
made for extraneous viruses.
Tests on virus harvest
Test in a number of different cell cultures and in small
animals
To cover all possible contaminating viruses.
Potency tests
Tests based on the clinical effectiveness of vaccines most of
Which are based on the responses of groups of animals to
Fractional doses of the vaccine, measurement of antibody
titres,screening of the sera of the vaccinated animals for an
arbitrary level of antibody ( the dose response curve )
sigmoid
linear is used to compare the potencies of any two vaccines
of the same type.For pertussis ,the graph is used to
calculate
Of the vaccines which would protect half the mice from
death
Comparing the vaccine on test with the standard vaccine-in

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