vaccine production, steps of vaccine production,

2. Represent By:
Somia Sahar
BS (Microbiology)

4. Vaccine is a biological preparation that
provides active acquired immunity to a
particular disease.
Vaccine is a suspension of organism that is
used to induced immunity.

5. Vaccine are produced in large scale as
they need to be administered to large
population of children and adults to be
effective as public health tool.
To synthesize a live attenuated vaccine the
disease causing organisms is grown under
laboratory conditions that cause to lose its
disease causing properties.

6.  The attenuated can be obtained by heat or by
passage of the virus in foreign host such as
embryonated eggs & tissue culture cells.
 Cell culture required for viral vaccine since
virus can replicate inside the living cells.
 e.g. to produce Sabin polio vaccine
attenuated was only achieved with high
inocula and rapid passage in primary monkey
kidney cells.

7. 1- Generation of the antigen
2-Release and isolation of the antigen
3-Purification
4-Addition of other components
5-Packaging

8.  For this purpose the pathogen’s protein and
DNA need to be grown & harvested using the
following mechanism:
 Viruses are grown on primary cells such as
cell from chicken embryos or using fertilised
eggs or cell line.
 Bacteria are grown in bioreactors.
 Recombinant proteins derived from the
pathogens can be generated in yeast,
bacteria or cell culture.

9. The aim of this is to release as much
viruses or bacteria as possible.
To achieve this the antigen will be
separated from the cell & isolate from the
protein & other parts of the growth medium
that are still present.

10. The antigen will need to be purified in
order to produce high quality product.
For weakened or attenuated viruses no
further purification may required.
Recombinant protein may need many
operations involving ultra filtration &
column chromatography for purification
before they are ready for administration.

11. Once the antigen is developed the vaccine
is formulated by adding adjutants stabilizer
& preservatives.
Adjutants enhance the immune response
of the antigen.
Stabilizer increase the storage life.
Preservatives allow the use of multi dose
vials.

12. The product need to be protected from air,
water and human contamination.
The environment need to be protected
from spillage of the antigens.

13. Once the vaccine is put in the recipient
vessels it is sealed with sterile stoppers.
GMPs will involve several quality controls
and an adequate infrastructure and
separation of activities to avoid cross
contamination.
Finally the vaccine is labeled and
distributed worldwide.