This slide is about knowleges of vaccine development. It mainly explains the following contents: goals of vaccine development, vaccine development stages, vaccine manufacturing, challenges for vaccine development, and the services Creative Biolabs can provide.

1. Vaccine Development
& GMP Manufacturing
Creative-biolabs.com/vaccine/

2. Goals of Vaccine Development
Vaccine Development Stages
Vaccine Manufacturing
Challenges for Vaccine Development
CONTENTS
1
2
3
4
www.creative-biolabs.com/vaccine/
5 Our Services

3. Vaccines are biological products that prevent and control the occurrence of infectious diseases,
epidemic.
Vaccine is designed to direct against:
 Fungi
 Parasitic
 Non-infectious Diseases
 Cancer Cells
 Autoimmune Disease
 Neurodegenerative
Disease Vaccines
 Bacteria
 Viruses
Goals of Vaccine Development
www.creative-biolabs.com/vaccine/

4. Clinical development is when the vaccine is first tested in humans.
Pre-clinical
Development
Clinical
Development
 Phase I clinical trials
 Phase II clinical trials
 Phase III clinical trials
 Phase Ⅳ clinical trials
Vaccine Development Stages
Pre-clinical development is research carried out in lab assays and on animals.
 Discovery of relevant antigens
 Evaluation of vaccine efficacy In
Vivo Assays and In Vitro Assays
 Vaccine concept design
 Manufacture of the vaccine
to Good Manufacturing
Practice standards
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5. Phase IIPhase I LicensePhase III
Safety
Immune response
Efficacy of the vaccine
Safety
Dose ranging
Side-effects
Immune response
Vaccine efficacy
under natural
disease conditions
Submission
Preparation
Post-marketing
surveillance
Phase IV
Small-scale
trials
Larger-scale
trails
Large-scale
trails
Vaccine Development Stages
Clinical development
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6. Good Manufacturing Practices (GMP)
Ensure that products are safe for
use in humans
Ensure that the identity, strength,
quality and purity of products
consistently meet regulatory
specifications.
Quality control measures
Vaccine Manufacturing
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7. Propagation
Isolate the
antigen
Purification Formulation Packaging
Amplify the
living organism
used in the
vaccine
Separate of the
living organism
from the
propagation step
Purify the
antigen to
produce a high
purity/quality
product.
Add other
components like
adjuvants,
preservatives,
stabilizers,
inactivators
Aseptic
packaging in
vials or syringes
Vaccine Manufacturing
www.creative-biolabs.com/vaccine/

8. A
B
C
Viruses are grown on primary cells such as cells from
chicken embryos or using fertilised eggs (e.g. influenza
vaccine) or cell lines that reproduce repeatedly (e.g.
hepatitis A)
Bacteria are grown in bioreactors which are devices that use a
particular growth medium that optimises the production of the
antigens
Recombinant proteins derived from the pathogen can
be generated either in yeast, bacteria or cell cultures
Vaccine Manufacturing
METHODS
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9. Challenges for Vaccine Development
www.creative-biolabs.com/vaccine/
Costs Identifying
appropriate
antigens
01 02 03
Adjuvants
selection
04
Acceptable
delivery system
05
Regulatory
approvals
06
Technical and
manufacturing
barriers

10. 02
01
0305
06
04
Pathogen/Target-Based
Vaccine Design
Process Development
& GMP Manufacturing
Formulation
Development
Adjuvant Selection
Vaccine Analytical
Development &
Qualification
Vaccine Preclinical
Assessment
CREATIVE
BIOLABS
Our Services
www.creative-biolabs.com/vaccine/

11. www.creative-biolabs.com/vaccine/
Address: 45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
Fax: 1-631-207-8356
E-Mail: info@creative-biolabs.com