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PHARMACEUTICAL
BIOTECHNOLOGY
P R E S E N T E D B Y H A R I S H K U S H WA H A
6 T H S E M E S T E R 3 R D Y E A R
GENERAL
METHOD OF THE
PREPARATION OF
THE FOLLOWING
 Bacterial Vaccines
 Toxoids
 Viral Vaccine
 Antitoxins
 Serum immune blood derivatives
 Other products relative to immunity
Vaccine are immunological preparation contain
suspension of weakned killer (made up of protiens)
or fragmented microorganism or toxins or of
antibodies or lymphocytes. That is administered
primarily to prevent diseases.
WHAT IS VACCINE..?
3
Vaccines are classified as follows based on the type of preparation involved
in the manufacture:
1. Inactivated killed vaccines : prepared by killing or inactivated pathogen ,
administered as primary dose and booster dose. (bacterial vaccine, Viral
vaccine)
2. Live Attenuated Vaccines: non virulent microorganism used that retained
its antigenicity, make an permanently immune against a disease. (Bacterial
Vaccines, Viral Vaccines)
3. Toxoids: prepared by treatment of bacterial toxins with formalin. (Tetanus
and diphtheria toxoids)
C L A S S I F I C AT I O N O F VA C C I N E
4
Bacterial vaccine are usually made either from the whole organism or from the
exotoxins, which have been shown responsible for the clinical symptom of the
disease.
They are categorized into two types:
1. Life attenuated vaccine ( eg. Typhoid Vaccine )
2. Inactivated vaccine ( Cholera Vaccine )
Preparation of bacterial vaccines involves:
Steps involved and killed bacterial vaccine preparation –
1. Selection of antigen : Selection of the suitable bacterial or antigen for the
preparation of vaccine Example, chlorea vaccine
2. Inoculation into media and incubation : Bacteria group in media those are rich
in protein, vitamins and salt, media that are often used in the production of
vaccin. The selected strain is inoculated into a solid or liquid medium and
incubated under optimum condition for 1-3 days.
B A C T E R I A L VA C C I N E S
5
3. Inactivation of cell suspension: The bacterial cell suspension is inactivated by
two different method (i) Heat method 56* C for two hours (ii) Using Chemicals
.5% of formalin
4. Standardization: The preparation or standardized by different methods. using
helber cell or hemocytometer method.
5. Formulation: The standardized cell suspension is formulated into final vaccine.
By incorporating. Some others
6
Toxoids are the immunological preparation gifts protection against disease
caused by some toxigenic stain.
Ability of the bacteria to produce toxins is called toxigecity.
At a chemical level, there are two main type of bacterial toxins :
1. Lipopolysaccharides, which are associated with the cell wall of bacteria and
proteins which are released from bacterial cells and may act as tissue sites
removed from the site of bacterial growth bacteria.
2. Diphtheria toxids is prepared by formaldehyde for treatment of toxins and in
standardized for potency, according to the specification of the US food and dye
administration.
A chemically modified toxin from a pathogenic microorganism, which is no longer
toxic, but is still antigenic and can be used as vaccine.
T O X O I D S
7
Formal Toxoid : It is prepared by selecting a suitable strain of bacteria cultivating
on a liquid medium and incubating under optimum condition until a satisfactory
level of toxin is produced.
Microorganism are retained on the paper pulp and filtration , filtrate is sterlized.
Formaldehyde solutions is added, and the mixture incubated at 37 *C to remove
toxicity.
The complete process takes two to three months.
Purified toxoid aluminum phosphate (PTAT) : It is prepared using a semi
synthetic medium excluding the tor specific material.
It can also be prepared by purifying the toxoid with magnesium hydroxide to
precipitate color, phosphate and some proteins.
PTAT also has a depot effect, slow release of antigen in the tissue to provide a
problem effect.
8
Viruses grow on a medium.
They cause infectious disease in human animals and plants. Some common viral
diseases are influenza, common cold, etc.
Viral vaccines are prepared using free living animals, fertile eggs and tissue
cultures.
Viruses are grown the Chrioallantoic membrane of incubated fertile hen eggs or
in whole animal.
Preparation of viral vaccine : Method of viral vaccine production :-
(1) Cultivation of virus using free living animals
(2) Fertile eggs
(3) Tissue cultures
V I R A L VA C C I N E S
9
Cultivation of virus using free living animal:
Nowadays, very few vaccines are made from virus grown in free living animals.
The product are good antigen, but the method is inconvenient and costly and
adventitous Contamination is difficult to prevent. In some part of the word typhus
vaccine is prepared from rickettsiae And Rabies vaccine may be produced from
the brain of sheep or rabbit.
Example: Smallpox (live vaccine)
Typhus vaccine (inactivated)
Fertile egg :
Many vaccine can be grown in some part of the chick embryo.
The advantage of this method over the use of free living animals include.
it is much easier to keep the product free from contamination microorganism at
the age of the embryo cannot produce antiviral antibodies, which might affect the
yield.
10
Tissue culture method :
It has been known by many years that Vaccinia virus will grow in certain minced
animal tissue kept alive in suitable solution of salt, but the Method remain
undeveloped as means of growing virus because of the success of chick embryo
techniques and the difficulty of preventing contamination of the cultures .
Steps involved in tissue culture method
1. Selection of suitable tissue
primary cell – deployed cell line – continuous cell line – stem cell
2. Media recommended for maintenance of the culture.
3. Cultivation of virus in the cells.
11
Antitoxins are antibodies that are used to protect the body by the process of
passive immunization. antitoxin is an immunoglobulin preparation obtained from
hyper immunized horses from which FC portion has been removed enzymatically
to reduce the incidence of side effects such as serum sickness and
hypersensitivity reactions.
An antitoxin is an antibody with the ability to neutralize a specific toxin, antitoxin
are produced by certain animal, plant and bacteria in response to toxin exposure.
Production :
Normally y-globulins are present in the anti serum that is produced in the serum
by an artificially inoculated animal. For commercial production, mainly horses are
used. Antisera can also be collected from humans recovering from viral infection.
The antibody developed against specific toxin or nouns antitoxin. Commercially
antitoxin are produced for the control of diphtheria. Botulism and tetanus.
A N T I T O X I N S
12
THANK YOU
HARISH KUSHWAHA
royalsehansha@gmail.com
6th Sem 3rd Year
GGITS – Pharmacy Jabalpur

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Vaccines.pptx unit 3 6th sem b.pharm derivatives off plasma substitute

  • 1. PHARMACEUTICAL BIOTECHNOLOGY P R E S E N T E D B Y H A R I S H K U S H WA H A 6 T H S E M E S T E R 3 R D Y E A R
  • 2. GENERAL METHOD OF THE PREPARATION OF THE FOLLOWING  Bacterial Vaccines  Toxoids  Viral Vaccine  Antitoxins  Serum immune blood derivatives  Other products relative to immunity
  • 3. Vaccine are immunological preparation contain suspension of weakned killer (made up of protiens) or fragmented microorganism or toxins or of antibodies or lymphocytes. That is administered primarily to prevent diseases. WHAT IS VACCINE..? 3
  • 4. Vaccines are classified as follows based on the type of preparation involved in the manufacture: 1. Inactivated killed vaccines : prepared by killing or inactivated pathogen , administered as primary dose and booster dose. (bacterial vaccine, Viral vaccine) 2. Live Attenuated Vaccines: non virulent microorganism used that retained its antigenicity, make an permanently immune against a disease. (Bacterial Vaccines, Viral Vaccines) 3. Toxoids: prepared by treatment of bacterial toxins with formalin. (Tetanus and diphtheria toxoids) C L A S S I F I C AT I O N O F VA C C I N E 4
  • 5. Bacterial vaccine are usually made either from the whole organism or from the exotoxins, which have been shown responsible for the clinical symptom of the disease. They are categorized into two types: 1. Life attenuated vaccine ( eg. Typhoid Vaccine ) 2. Inactivated vaccine ( Cholera Vaccine ) Preparation of bacterial vaccines involves: Steps involved and killed bacterial vaccine preparation – 1. Selection of antigen : Selection of the suitable bacterial or antigen for the preparation of vaccine Example, chlorea vaccine 2. Inoculation into media and incubation : Bacteria group in media those are rich in protein, vitamins and salt, media that are often used in the production of vaccin. The selected strain is inoculated into a solid or liquid medium and incubated under optimum condition for 1-3 days. B A C T E R I A L VA C C I N E S 5
  • 6. 3. Inactivation of cell suspension: The bacterial cell suspension is inactivated by two different method (i) Heat method 56* C for two hours (ii) Using Chemicals .5% of formalin 4. Standardization: The preparation or standardized by different methods. using helber cell or hemocytometer method. 5. Formulation: The standardized cell suspension is formulated into final vaccine. By incorporating. Some others 6
  • 7. Toxoids are the immunological preparation gifts protection against disease caused by some toxigenic stain. Ability of the bacteria to produce toxins is called toxigecity. At a chemical level, there are two main type of bacterial toxins : 1. Lipopolysaccharides, which are associated with the cell wall of bacteria and proteins which are released from bacterial cells and may act as tissue sites removed from the site of bacterial growth bacteria. 2. Diphtheria toxids is prepared by formaldehyde for treatment of toxins and in standardized for potency, according to the specification of the US food and dye administration. A chemically modified toxin from a pathogenic microorganism, which is no longer toxic, but is still antigenic and can be used as vaccine. T O X O I D S 7
  • 8. Formal Toxoid : It is prepared by selecting a suitable strain of bacteria cultivating on a liquid medium and incubating under optimum condition until a satisfactory level of toxin is produced. Microorganism are retained on the paper pulp and filtration , filtrate is sterlized. Formaldehyde solutions is added, and the mixture incubated at 37 *C to remove toxicity. The complete process takes two to three months. Purified toxoid aluminum phosphate (PTAT) : It is prepared using a semi synthetic medium excluding the tor specific material. It can also be prepared by purifying the toxoid with magnesium hydroxide to precipitate color, phosphate and some proteins. PTAT also has a depot effect, slow release of antigen in the tissue to provide a problem effect. 8
  • 9. Viruses grow on a medium. They cause infectious disease in human animals and plants. Some common viral diseases are influenza, common cold, etc. Viral vaccines are prepared using free living animals, fertile eggs and tissue cultures. Viruses are grown the Chrioallantoic membrane of incubated fertile hen eggs or in whole animal. Preparation of viral vaccine : Method of viral vaccine production :- (1) Cultivation of virus using free living animals (2) Fertile eggs (3) Tissue cultures V I R A L VA C C I N E S 9
  • 10. Cultivation of virus using free living animal: Nowadays, very few vaccines are made from virus grown in free living animals. The product are good antigen, but the method is inconvenient and costly and adventitous Contamination is difficult to prevent. In some part of the word typhus vaccine is prepared from rickettsiae And Rabies vaccine may be produced from the brain of sheep or rabbit. Example: Smallpox (live vaccine) Typhus vaccine (inactivated) Fertile egg : Many vaccine can be grown in some part of the chick embryo. The advantage of this method over the use of free living animals include. it is much easier to keep the product free from contamination microorganism at the age of the embryo cannot produce antiviral antibodies, which might affect the yield. 10
  • 11. Tissue culture method : It has been known by many years that Vaccinia virus will grow in certain minced animal tissue kept alive in suitable solution of salt, but the Method remain undeveloped as means of growing virus because of the success of chick embryo techniques and the difficulty of preventing contamination of the cultures . Steps involved in tissue culture method 1. Selection of suitable tissue primary cell – deployed cell line – continuous cell line – stem cell 2. Media recommended for maintenance of the culture. 3. Cultivation of virus in the cells. 11
  • 12. Antitoxins are antibodies that are used to protect the body by the process of passive immunization. antitoxin is an immunoglobulin preparation obtained from hyper immunized horses from which FC portion has been removed enzymatically to reduce the incidence of side effects such as serum sickness and hypersensitivity reactions. An antitoxin is an antibody with the ability to neutralize a specific toxin, antitoxin are produced by certain animal, plant and bacteria in response to toxin exposure. Production : Normally y-globulins are present in the anti serum that is produced in the serum by an artificially inoculated animal. For commercial production, mainly horses are used. Antisera can also be collected from humans recovering from viral infection. The antibody developed against specific toxin or nouns antitoxin. Commercially antitoxin are produced for the control of diphtheria. Botulism and tetanus. A N T I T O X I N S 12
  • 13. THANK YOU HARISH KUSHWAHA royalsehansha@gmail.com 6th Sem 3rd Year GGITS – Pharmacy Jabalpur