This document discusses vaccines, including their history, principles, classifications, production process, and uses. It defines vaccines as agents that enhance active immunity in the body. It describes how Edward Jenner demonstrated in 1798 that cowpox could prevent smallpox in humans. The basic principle of vaccination is that it causes the body to develop antibodies and memory cells to quickly fight disease upon future exposure. Vaccines are classified based on whether they contain live weakened pathogens, killed pathogens, pathogen subunits, or toxins. The production process involves generating antigens, purification, inactivation, formulation, filling, batch testing, and distribution.

1. Vaccines
Nikam Saurabh Devidas
F.Y M. PHARMACY
SEMESTER II
K.B.H.S.S. Tr’s I.O.P MALEGOAN

2. Content
 Introduction
 History
 Principle of Vaccination
 Classification
 What vaccines do?
 Production of Vaccines
 Reference

3. Introduction
 Definition
 Vaccines: Vaccine may be defined as the agent which enhance the active immunity of the
body. They give us a healthy defense. The vaccine used to treat for a particular infection is
called "vaccination".
 Vaccination : a procedure designed to increase concentrations of antibodies and/or effector
T- cells which are reactive against infection (or cancer).

4. History
• The word 'Vaccine" originates from the Latin word
vaccines.
• Edward Jenner demonstrated in 1798 could prevent
smallpox in humans.
• Today the term "Vaccine" applies to all biological
preparations, produced from living organisms, that
enhance immunity against disease.
Edward Jenner
1749- 1823

5. Principle of Vaccination
 The basic principle of immunization is that on administration of vaccine, the body starts
developing antibodies against it such that person is protected form disease.
 Body remembers the infectious agents and memory cells are formed which can
immediately produce antibodies on further exposure to the infectious agents.
 This way disease are prevented

6. What vaccine do?
 When inactivated or weakened disease-causing microorganisms enter the body, they
initiate an immune response.
 This response mimics he body's natural response to infection.
 These antigens triggers the production of Antibodies by the immune system.
 Antibodies bind to corresponding antigens and induce their destruction by
other immune cells.

7. Classification
Vaccine characteristics Example
Live Vaccines  Contain weak microbe or virus
 Provide lifelong immunity
 More closely mimic to actual infection
 Achieved without booster immunization
 Measles
 Mumps
 Rubella vaccine
 Varicella (Chickenpox)
Vaccine
 Small pox
Inactivated Vaccine  Contain killed Bacteria or virus
 Safer than live Vaccines
 Required repeated booster dose
 Induce humoral antibody immunity
 Hepatitis A
 Flu
 Polio Vaccine
 Rabies Vaccine

8. Classification
Vaccine characteristics Example
Sub Unit Vaccine  Only contain specific Component of
bacteria which produce immune
response
 Hepatitis B Vaccine
Toxoid Vaccines  Contain toxin made by Bacteria that
cause disease
 Immune response is triggered by
toxin instead of whole germ
 Diphtheria Vaccines
 Tetanus Vaccine

9. classification
Vaccine characteristics Example
Conjugated
Vaccine
 Type of subunit Vaccine
 Combines antigen with protein that boost immune
response
 Composed of polysaccharide antigen conjugated
with carrier molecule (protein)
 Hemophilus
influenza
vaccine
 Hib conjugate
Vaccine
DNA Vaccine  Still in the experimental stage
 Uses only the DNA form infectious organism
 Provide both Humoral and cell mediated immunity
 Easy to produce
 Influenza virus
 Hepatitis B
 Rabies virus

10. Production of Vaccine
Stages of production
 Generation /Isolation of Antigen
 Purification
 Inactivation
 Formulation
 Filling
 Batch release
 Packing and shipping

11. Generation /Isolation of Antigen
 Viruses are grown on primary cells such as cells from chicken embryos or using fertilized
eggs (e. g. influenza vaccine)or cell lines that reproduce repeatedly(e.g. hepatitis).
 Bacteria are grown in bioreactors which are devices that use a particular growth medium
that optimizes the production of the antigens
 Recombinant proteins derived from the pathogen can be generated either in yeast, bacteria
or cell cultures.
 Production starts by growing viruses bacteria in the lab a wide range of program meter
manages like -Temperatures
-Oxygen Rate
-Sterility
-PH Homogeneity

12. Purification
 The microorganisms are extracted from the environment through a process called
purification which are ruminates any traces in culture media.

13. Inactivation
 Done by using chemicals and radiation process
 That inactivated virus or bacteria called Valence

14. Formulation
 Once the antigen is developed the vaccine is formulated by adding adjuvant, stabilizers,
and preservatives.
 The role of the adjuvant is to enhance the immune response of the antigen
 The stabilizers increase the storage life, and preservatives use of allow multi dose vials.

15. Filling
 When its times for the vaccine to be administrated it would be reconstituted by combining
the powder with diluents.
 The vaccine is liquid or freeze dried form and diluents is needed and then filled into seeds
or syringes.
 Each phase undergoes visual inspection.
 Quality containers are scrutinized by human eye and sterile in digital
surveillance technology.

16. Batch release
 Samples are taken from each batch.
 After vaccines are successfully passed both sides of test distribution began
 No exception if a batch is not matched with quality criteria will be destroyed.

17. Packing and shipping
 For the packing and shipping vaccine must be stored in 2º to 8°C.
 Temperatures tracking device is included in each shipment.

18. Reference
 http://www.biotec.or.th/biosafety/download/biotec%zoseminar z.pdf
 http://www.cfsciences.com/pdf/
 www.hsc.gov.sg
 www.sonofi.com
 www.sciencedirect.com