Page 153 - Pharmaceutics IV (02-06-01305)

Bacterial seed strain
Toxins filtered from culture &toxoided yield of toxins is
important ,little significance of the inherent safety of
bacterial
strain.Suspensions vaccines of killed bacteria ,greater
emphasis on the immunogenicity of the strain than their
tonicity,only danger lies in the quantity of protein injected
in
the dose.All bacterial vaccines give some local reactions
(not
dangerous).
Substrate for bacterial growth
e.g.Peptones ,the only concern in killed bacterial
suspension
vaccine is the presence of an endotoxin,its conc.is affected
by
substrate -----controlled by intradermal tests in animals.
Safety tests of bacterial vaccines
Animal tests,potency &freedom from abnormal toxicity ,in-
vivo tests to ensure bacterial sterility.
For killed bacterial vaccines --- excessive protein in single
dose.Lower limit is placed on potency & upper limit on

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