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Prepared and represented
by
Hassan Aboul-Ella Otefi
Junior teaching assistant, department of Microbiology, Cairo University
5 golden rules
• Enjoy learning
• Don’t bother your self by writing everything, just few notes will be
good
• Give your mind a chance to do what it is created for!? …Thinking
• Please, ask, ask and ask again, if you don’t understand, if you doubt, if
you understand, even if you fall asleep during a class the first thing
you should do when you wakeup is to………. ask
• Don’t forget the previously mentioned 4 rules
I have a little story, I want to
share it with all of you
It is a story of
everlasting game
between the
human and
infectious
diseases
The Miasmatic
theory
Now we Know who is the enemy
History of medicine
1. Medicine at 1800 and before
2. The rise of scientific medicine in
the 19th century
3. Medicine in the 20th century and
after
chemotherapy
Nano-medicine
Immunization
• The Antibody dependent medicinal era
Immunization
The whole future of medicine from it both sides (either
diagnosis or treatment) depends on the “Magical molecule”…The
“Golden Bullet”
Antibodies Plastic antibodies Antibodies mimetics
Diagnosis
Treatment
Conventional
full length
antibody
Nano
fragmented
antibody
Monoclonal
Polyclonal Affibodies
Addectins
Peptide aptamers
Peptide affimers
Affitins
Anticalins
Avimers
Fynomers
armadillo repeat proteins
knottins
Polymer
nanoparticles
Treatment
Antibody
Artificially
acquired passive
immunity
Artificially
acquired active
immunity
Antisera
Vaccine
Why there is no vaccine for
every thing ?
Vaccinology
Industrial
vaccinology
Clinical
vaccinology
Traditional
empirical
vaccinology
Last 30 years
new
technology
dependent
vaccinology
Recombinant DNA vaccine
Glycoconjugation vaccine
Reverse vaccine
Next generation Vaccine
Subunit vaccine
Killed inactivated vaccine
Live attenuated vaccine
Synthetic biologics/RNA
vaccine
Adjuvant vaccine
Structural vaccine
The mother
of
vaccinology
is the
Natural
immunity
Toxoid vaccine
Exploratory (vaccine design): This research-intensive phase of the
vaccine development process is to identify antigens that might help
prevent or treat a disease.
Pre-clinical: researchers use tissue-culture or cell-culture systems and
animal testing to determine whether the vaccine will produce
immunity. Many vaccines don’t move on to the next stage of
development because they fail to produce that immunity or prove
harmful to test subjects.
Clinical development: An institution that will host the clinical trial holds a
review board for approval of the application. Once the proposal has been
approved, the vaccine must pass three trial stages of human testing:
Phase I administers the vaccine to a small group (less than 100 people) with
the goal of determining whether the candidate vaccine is safe and to learn
more about the responses it provokes among test subjects.
Phase II includes hundreds of human test subjects, aims to deliver more
information about safety, immunogenicity, immunization schedule and dose
size.
Phase III thousands or tens of thousands of test subjects, continues to
measure the safety (rare side effects sometimes don’t appear in smaller
groups) and effectiveness of the vaccine.
Regulatory review and approval: If a vaccine passes through all three
phases of clinical development, the vaccine developer submits a
Biologics License Application (BLA).
Manufacturing: Major drug manufacturers provide the infrastructure,
personnel and equipment necessary to create mass quantities of
vaccines.
The cold chain
The 'cold chain' is a system of storing and transporting vaccines at
recommended temperatures from the point of manufacture to the
point of use. That is, the role of the cold chain is to maintain the
potency of vaccines. There is also a concept called 'reverse cold chain',
which is a system of storing and transporting samples at recommended
temperatures from the point of collection to the laboratory.
Equipment used in cold chain
Introduction to vaccine and serum industry I

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Introduction to vaccine and serum industry I

  • 1. Prepared and represented by Hassan Aboul-Ella Otefi Junior teaching assistant, department of Microbiology, Cairo University
  • 2. 5 golden rules • Enjoy learning • Don’t bother your self by writing everything, just few notes will be good • Give your mind a chance to do what it is created for!? …Thinking • Please, ask, ask and ask again, if you don’t understand, if you doubt, if you understand, even if you fall asleep during a class the first thing you should do when you wakeup is to………. ask • Don’t forget the previously mentioned 4 rules
  • 3.
  • 4.
  • 5. I have a little story, I want to share it with all of you
  • 6.
  • 7. It is a story of everlasting game between the human and infectious diseases The Miasmatic theory
  • 8. Now we Know who is the enemy
  • 9. History of medicine 1. Medicine at 1800 and before 2. The rise of scientific medicine in the 19th century 3. Medicine in the 20th century and after chemotherapy Nano-medicine Immunization
  • 10. • The Antibody dependent medicinal era Immunization
  • 11. The whole future of medicine from it both sides (either diagnosis or treatment) depends on the “Magical molecule”…The “Golden Bullet” Antibodies Plastic antibodies Antibodies mimetics Diagnosis Treatment Conventional full length antibody Nano fragmented antibody Monoclonal Polyclonal Affibodies Addectins Peptide aptamers Peptide affimers Affitins Anticalins Avimers Fynomers armadillo repeat proteins knottins Polymer nanoparticles
  • 13. Why there is no vaccine for every thing ?
  • 14.
  • 15.
  • 16. Vaccinology Industrial vaccinology Clinical vaccinology Traditional empirical vaccinology Last 30 years new technology dependent vaccinology Recombinant DNA vaccine Glycoconjugation vaccine Reverse vaccine Next generation Vaccine Subunit vaccine Killed inactivated vaccine Live attenuated vaccine Synthetic biologics/RNA vaccine Adjuvant vaccine Structural vaccine The mother of vaccinology is the Natural immunity Toxoid vaccine
  • 17.
  • 18.
  • 19. Exploratory (vaccine design): This research-intensive phase of the vaccine development process is to identify antigens that might help prevent or treat a disease.
  • 20. Pre-clinical: researchers use tissue-culture or cell-culture systems and animal testing to determine whether the vaccine will produce immunity. Many vaccines don’t move on to the next stage of development because they fail to produce that immunity or prove harmful to test subjects.
  • 21. Clinical development: An institution that will host the clinical trial holds a review board for approval of the application. Once the proposal has been approved, the vaccine must pass three trial stages of human testing: Phase I administers the vaccine to a small group (less than 100 people) with the goal of determining whether the candidate vaccine is safe and to learn more about the responses it provokes among test subjects. Phase II includes hundreds of human test subjects, aims to deliver more information about safety, immunogenicity, immunization schedule and dose size. Phase III thousands or tens of thousands of test subjects, continues to measure the safety (rare side effects sometimes don’t appear in smaller groups) and effectiveness of the vaccine.
  • 22. Regulatory review and approval: If a vaccine passes through all three phases of clinical development, the vaccine developer submits a Biologics License Application (BLA).
  • 23. Manufacturing: Major drug manufacturers provide the infrastructure, personnel and equipment necessary to create mass quantities of vaccines.
  • 24.
  • 25.
  • 26. The cold chain The 'cold chain' is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of use. That is, the role of the cold chain is to maintain the potency of vaccines. There is also a concept called 'reverse cold chain', which is a system of storing and transporting samples at recommended temperatures from the point of collection to the laboratory.
  • 27. Equipment used in cold chain