Hib疫苗生产和制造工艺_英文版录入

2021年1月25日发(作者：郝执斋)
Haemophilus influenzae
Type b Conjugate Vaccine

Haemophilus influenzae
Type b Conjugate V
accine is a preparation made by covalently binding
the
purified
capsular
polysaccharide
(CPS)
antigen
from
Haemophilus
influenzae
Type
b
to
tetanus toxoid through the linkage of adipic dihydrazide (ADH). It is used to prevent childhood
infectious diseases caused by
Haemophilus influenzae
Type b, such as cerebrospinal meningitis,
and pneumonia, etc.
1

Basic requirement

The facilities, source and subsidiary materials, water, apparatus, and animals used for production
and quality control shall comply with the requirements set forth in the General Notices.
2

Manufacturing
2.1

Bacterial seed

The
bacterial
seed
used
for
production
complies
with
the
Requirements
for
Bacterial
and
Viral
strains/seeds Used for Production and Quality Control of Biologics.
2.1.1

Name and origin of bacterial strains
The
bacterial
strain
used
for
production
shall
be
Haemophilus
influenzae

type
b
strain
CMCC58547 or CMCC58534.
2.1.2

Establishment of seed lot system
It complies with the Requirements for Bacterial and Viral strains/seeds Used for Production and
Quality Control of Biologics.
2.1.3

Passage of seed lots
The subculture of the seed from master seed lot to working seed lot shall not exceed five passages;
the subculture of the seed from working seed lot to the final fermentation shall not exceed five
passages.
2.1.4

Control tests on the seed lots
Chocolate agar medium containing sheep blood or Hib comprehensive medium can be used for the
control tests on the seed lots.
2.1.4.1

Cultural characteristics
The Hib strain shall not grow on a common agar medium, but grow on a chocolate agar medium
containing
sheep
blood
or
a
Hib
comprehensive
medium.
Its
growth
requires
Factor
X
( chlorhematin ) and Factor V (
β

coenzyme A
)
; the satellite phenomenon shall be positive; the
colonies shall be greyish-white, translucent, smooth, convex and humid with regular edge.
2.1.4.2

Microscopic examination of stained smears
The
stained
smears
made
from
the
culture
shall
be
Gram- negative
capsulated
coccobacillus,
sometimes in short chain, or single Gram- negative coccus.
2.1.4.3

Biochemical reactions
The culture shall ferment glucose, xylose and galactose, with the production of acid but no gas.
They
shall
not
ferment
sucrose,
lactose,
or
fructose.
The
lysine
decarboxylase
reaction
shall
be
negative.
2.1.4.4

Serological test
After incubation at 35-37
℃
, take the lawn to perform a slide agglutination test with Hib antiserum,
It shall give a strong agglutination.

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