Presented by
Immunological product
MissrajdeoA.V. (Assistant Professor)
PRES’SInstituteof pharmacy
loni
IMMUNOLOGICAL
PRODUCT FOR ACTIVE
IMMUNISATION
1. BCG Vaccine (bacilli calmette guerin
strain)
 It is a form of white pellet
,Which when reconstituted
Yield opalescent suspension.
 It is a freeze dried preparation
containing live culture of
mycobacterium tuberculosis .
Method of preparation of BCG
Bacilli are grown on suitable culture media
It show 20 millions colonies on 1 mg plated
(growth period is not less than 14
days )
Colonies are separated by filtration to form a
cake
The cake is homogenized by grinding flask
Suspended in a sterile liquid medium.
( To preserve antigenicity and
viability.)
Transfer in container
Freeze dried
Seal in final container.
Storage – hermetically sealed in light
resistance container and temp between 2 to 8
degree Celsius. reconstituted at time of use and
use immediately .
Dose- 0.1 ml
Use – provide protection against tuberculosis
Cholera vaccines
Cholera vaccines is a colorless whitish or slightly
coloured opalescent liquid
It is sterile suspension of killed cholera
vibrio's.(vibrio cholerae) of strain selected for
high antigenic property and purity.
Preparation-
It is prepared from equal portion of cholera
vibrio's of vibrio cholerae inaba and ogawa
strains selected for high antigenic efficiency
Each stain of cholera vibrio grow separately on
solid medium
24 to48 h.
Bacteria are then wash with normal saline
solution.
Suspension of bacteria
56degree Celsius for1hroralcohol
additionorphenolorformaldehyde to
Kill them
All precaution to be taken antigenic property of
product not destroy
Preparation then standardize 1 ml of vaccine
contain not less than 12,000 million bacteria
Adding suitable preservative
Transfer in to final container.
Sealed
Vaccines must complied test for sterility and test
for toxicity
Uses
It is used as immunization against cholera .
But it has a limited use about 50% effectiveness
for period of 3 to 6 month
Vaccines does not prevent transmission of
disease .
DOSE
Initial dose 0.5ml
Second dose 1ml after an interval 4 to 6 weeks.
Storage
Store at temp. between 2 to 8 degree Celsius.
Pertussis vaccine(whooping cough vaccine)
It is available as more or less turbid.
It is a whitish liquid nearly odorless or having
faint odours due to antimicrobial agent.
It is a sterile bacterial suspension of killed
pertussis bacilli (Bordetella pertussis)
Strain selected for high antigenic efficiency.
Preparation
 Bordetela pertussis culture in a suitable culture
media
 It is separated
 Washed
 Suspended in normal saline solution
 Standardize
 Vaccine may show abnormal toxicity in animal
test.
 This is removed by cold storage up to 3months
Storage
it is stored at a temp.between 2 to 8 degree
Celsius.
Uses
It is used as active immunization against
Whooping cough
Dose
s.c injection in 3 doses
Of 0.5 ml 1.0 ml and 1.5 ml at list 4 week apart
Typhoid vaccines .
• It is white or creamy white turbid liquid free
from clumps.
• It is sterile suspension prepared from one or
more strain of salmonella typhi .
• That are a smooth and have full component of
O,H and vi antigen
Preparation
Salmonella typhi +suitable culture
grown
Wash sterile liquid
Suspension in sterile liquid
Bacteria are killed by use
Bactericide i.e phenol, formaldehyde ,acetone
Standardize
1.0 ml of typhoid vaccines contain
Not less than 1000 million bacteria
Comply test sterility & toxicity
Storage
Store at tem between 2 to 8 degree Celsius
The vaccines do not be frozen .
use
Immunization against infection caused by
Typhoid bacilli.
• DOSE
• Initial dose 0.5 ml followed by
• Second dose of 1.0 ml sc injection after an
interval 4 to 6 week
Viral and rickettsial vaccines
It is a suspension of viral or rickettsial.
The are prepared from tissue of blood obtained
for artificially infected animal.
From culture of eggs or from cell of tissue
culture.
Viral vaccines may be live or killed.
Kill vaccines may be inactivated by suitable
chemical or by physical method.
Small pox vaccines
It is a freeze dried product.
It is white with reconstituted yield.
It contain living attenuated virus.
The vaccines is prepared by two method.
1. By using animal
2. By using eggs.
• Small pox vaccine is prepared by two
methods 1) By using animals 2) By using
Eggs
• By using Animals : it is done in following
steps
• Selection of Animals: Healthy Sheep or calves
selected and kept in an isolated area for
• 10-14 days under observation, it should be free
from diseases.
• ↓
• Preparation of animal for scarification
(Abdomen and flanks are scrubbed, wash and
disinfected)
Inoculation
(Light incisions are made on clear skin by
scarifier, seed vaccine is inoculated in that
area)
↓
Incubation
(Incubate for 7-9 days, kept clean and aseptic,
pustules are formed on line of
Scarification).
↓
Collection of viruses
(Abdomen and flanks are washed with sterile
water. The Pustules are withdrawn
aseptically)
↓
Purification( mixed with equal volume of
glycerin, cool and finely ground and store at -
10°C
↓
Filling and sealing (filled in final container and
sealed aseptically)
By using eggs:
Hen egg is used
(Which is incubated after 12 days)
↓
Small cut on the shell
(exposed chorio-allantoic membrane)
↓
In this membrane, viruses are inoculated
(by seed of known potency )
↓
Cut was sealed by flap or paraffin wax
↓
Again incubate for 72 hours
↓
Using aseptic condition, shell is removed and
chorio-allantoic membrane is
separated
↓
Contents are added in normal saline solution at 0° C
↓
Add 50 % glycerin
↓
Material is ground to produce homogenized
suspension.
↓
Transfer to suitable sterile container and freeze
dried
Storage
Store at temp between 2and8 degree Celsius.
The reconstituted vaccine may use immediately. but
within 7 days are kept in 2 to 8 degree Celsius.
Uses
smallpox disease can be eradicated from India.
The vaccines is indicated for small no of laboratory
worker who are likely to have contact with vaccinia
viruses and for travel to those country whish
required vaccination as condition of entry.
Thank You

IMMUNOLOGICAL PRODUCT FOR ACTIVE IMMUNISATION.pptx

  • 1.
    Presented by Immunological product MissrajdeoA.V.(Assistant Professor) PRES’SInstituteof pharmacy loni
  • 2.
    IMMUNOLOGICAL PRODUCT FOR ACTIVE IMMUNISATION 1.BCG Vaccine (bacilli calmette guerin strain)  It is a form of white pellet ,Which when reconstituted Yield opalescent suspension.  It is a freeze dried preparation containing live culture of mycobacterium tuberculosis .
  • 3.
    Method of preparationof BCG Bacilli are grown on suitable culture media It show 20 millions colonies on 1 mg plated (growth period is not less than 14 days ) Colonies are separated by filtration to form a cake The cake is homogenized by grinding flask Suspended in a sterile liquid medium.
  • 4.
    ( To preserveantigenicity and viability.) Transfer in container Freeze dried Seal in final container.
  • 5.
    Storage – hermeticallysealed in light resistance container and temp between 2 to 8 degree Celsius. reconstituted at time of use and use immediately . Dose- 0.1 ml Use – provide protection against tuberculosis
  • 6.
    Cholera vaccines Cholera vaccinesis a colorless whitish or slightly coloured opalescent liquid It is sterile suspension of killed cholera vibrio's.(vibrio cholerae) of strain selected for high antigenic property and purity. Preparation- It is prepared from equal portion of cholera vibrio's of vibrio cholerae inaba and ogawa strains selected for high antigenic efficiency
  • 7.
    Each stain ofcholera vibrio grow separately on solid medium 24 to48 h. Bacteria are then wash with normal saline solution. Suspension of bacteria 56degree Celsius for1hroralcohol additionorphenolorformaldehyde to Kill them
  • 8.
    All precaution tobe taken antigenic property of product not destroy Preparation then standardize 1 ml of vaccine contain not less than 12,000 million bacteria Adding suitable preservative Transfer in to final container. Sealed
  • 9.
    Vaccines must compliedtest for sterility and test for toxicity Uses It is used as immunization against cholera . But it has a limited use about 50% effectiveness for period of 3 to 6 month Vaccines does not prevent transmission of disease . DOSE Initial dose 0.5ml Second dose 1ml after an interval 4 to 6 weeks.
  • 10.
    Storage Store at temp.between 2 to 8 degree Celsius.
  • 11.
    Pertussis vaccine(whooping coughvaccine) It is available as more or less turbid. It is a whitish liquid nearly odorless or having faint odours due to antimicrobial agent. It is a sterile bacterial suspension of killed pertussis bacilli (Bordetella pertussis) Strain selected for high antigenic efficiency.
  • 12.
    Preparation  Bordetela pertussisculture in a suitable culture media  It is separated  Washed  Suspended in normal saline solution  Standardize  Vaccine may show abnormal toxicity in animal test.  This is removed by cold storage up to 3months
  • 13.
    Storage it is storedat a temp.between 2 to 8 degree Celsius. Uses It is used as active immunization against Whooping cough Dose s.c injection in 3 doses Of 0.5 ml 1.0 ml and 1.5 ml at list 4 week apart
  • 14.
    Typhoid vaccines . •It is white or creamy white turbid liquid free from clumps. • It is sterile suspension prepared from one or more strain of salmonella typhi . • That are a smooth and have full component of O,H and vi antigen
  • 15.
    Preparation Salmonella typhi +suitableculture grown Wash sterile liquid Suspension in sterile liquid Bacteria are killed by use Bactericide i.e phenol, formaldehyde ,acetone Standardize 1.0 ml of typhoid vaccines contain Not less than 1000 million bacteria Comply test sterility & toxicity
  • 16.
    Storage Store at tembetween 2 to 8 degree Celsius The vaccines do not be frozen . use Immunization against infection caused by Typhoid bacilli. • DOSE • Initial dose 0.5 ml followed by • Second dose of 1.0 ml sc injection after an interval 4 to 6 week
  • 17.
    Viral and rickettsialvaccines It is a suspension of viral or rickettsial. The are prepared from tissue of blood obtained for artificially infected animal. From culture of eggs or from cell of tissue culture. Viral vaccines may be live or killed. Kill vaccines may be inactivated by suitable chemical or by physical method.
  • 18.
    Small pox vaccines Itis a freeze dried product. It is white with reconstituted yield. It contain living attenuated virus. The vaccines is prepared by two method. 1. By using animal 2. By using eggs.
  • 19.
    • Small poxvaccine is prepared by two methods 1) By using animals 2) By using Eggs • By using Animals : it is done in following steps • Selection of Animals: Healthy Sheep or calves selected and kept in an isolated area for • 10-14 days under observation, it should be free from diseases. • ↓ • Preparation of animal for scarification (Abdomen and flanks are scrubbed, wash and disinfected)
  • 20.
    Inoculation (Light incisions aremade on clear skin by scarifier, seed vaccine is inoculated in that area) ↓ Incubation (Incubate for 7-9 days, kept clean and aseptic, pustules are formed on line of Scarification). ↓ Collection of viruses (Abdomen and flanks are washed with sterile water. The Pustules are withdrawn aseptically)
  • 21.
    ↓ Purification( mixed withequal volume of glycerin, cool and finely ground and store at - 10°C ↓ Filling and sealing (filled in final container and sealed aseptically)
  • 22.
    By using eggs: Henegg is used (Which is incubated after 12 days) ↓ Small cut on the shell (exposed chorio-allantoic membrane) ↓ In this membrane, viruses are inoculated (by seed of known potency ) ↓ Cut was sealed by flap or paraffin wax ↓ Again incubate for 72 hours
  • 23.
    ↓ Using aseptic condition,shell is removed and chorio-allantoic membrane is separated ↓ Contents are added in normal saline solution at 0° C ↓ Add 50 % glycerin ↓ Material is ground to produce homogenized suspension. ↓ Transfer to suitable sterile container and freeze dried
  • 24.
    Storage Store at tempbetween 2and8 degree Celsius. The reconstituted vaccine may use immediately. but within 7 days are kept in 2 to 8 degree Celsius. Uses smallpox disease can be eradicated from India. The vaccines is indicated for small no of laboratory worker who are likely to have contact with vaccinia viruses and for travel to those country whish required vaccination as condition of entry.
  • 25.