Ixiaro

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension
for intramuscular injection. Each dose of vaccine contains approximately 6 mcg
of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The
appearance of the liquid is a white, opaque, non-uniform suspension which becomes
homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese
Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA₁₄-14-2
in Vero cells. Multiple viral harvests are performed, which are pooled, clarified
and concentrated. The virus suspension is treated with protamine sulfate to
remove contaminating DNA and proteins. The resulting partially purified virus
is processed through a sucrose density gradient centrifugation step and fractionated.
Each fraction is analyzed for the presence of virus, and fractions with the
highest virus activity are pooled to give a purified virus suspension. The purified
virus is then inactivated by treatment with formaldehyde. The preparation is
adjusted to a specified protein concentration and formulated by addition of
aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL
per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde
(not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200
ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not
more than 1μg/mL). No preservatives, stabilizers, or antibiotics are added
to the formulation.