What are Vaccines? its Types, Bioassay & Quality Control & Quality Assurance in Vaccine Development

Vaccines

This video tells about different steps involved in Bioassay quality control and quality assurance during vaccine discovery, development and commercialization of new vaccine

What are Vaccines?

''Vaccines are preparation that induce immune response Vaccines for human use may contain whole microorganisms or that have been treated to attenuate their virulence whilst retaining adequate immunogenic properties; antigens extracted from microorganisms or secreted by microorganisms or produced by genetic engineering or chemical synthesis Vaccines may contain an adjuvant where the antigen is adsorbed on a mineral adjuvant,the vaccine is referred to as“adsorbed”.
COMPONENTS OF VACCINES.''

UNDERSTANDING THE TYPES OF VACCINES.
1. LIVE VACCINES
2. KILLED VACCINES
3. TOXOID VACCINES
4. SUB-UNIT VACCINES
5. CONJUGATE VACCINES
6. COMBINED VACCINE
ADJUVANTS for vaccines like Aluminium hydroxide gel (hydrated aluminium oxide.

QUALITY CONTROL OF VACCINES
Quality Control and Quality Assurance in Vaccine Development.
Quality Control for Vaccines
#Quality_Control_for_Vaccines
#bioassay_of_vaccines

-ASSAY DEVELOPMENT for each type of vaccines
-Live-attenuated viral vaccine assays
-Recombinant protein vaccine assays
-ACCELERATED STABILITY STUDIES for vaccines
-STABILITY INDICATING PARAMETERS for vaccines
-STRESS TESTING
-VACCINE PRODUCTION PROCESS
-REAL-TIME/CONDITION STABILITY STUDIES
-Thermal stability for bioassay vaccines
-Utilization period for bioassay vaccines
-SO WHAT SHOULD BE TESTED for bioassay vaccines?
-QUALITY ASSURANCE OF VACCINE.
-HOW TO CHOOSE STABILITY INDICATING PARAMETERS THEN?
-CUMULATIVE AGE OF AN ANTIGEN: WHAT IS IT AND IS IT IMPORTANT?
-INTERMEDIATES in vaccines production

--PHYSICOCHEMICAL CHARACTERIZATION OF VACCINES

1. UV/visible or mass spectrometry
2. amino acid analysis
3. nucleic acid sequencing
4. carbohydrate analysis
5. peptide mapping
6. determination of disulfide linkage
7. Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis (SDS-PAGE)
8. Isoelectric focusing (1D or 2D);
9. Various chromatographic methods such as HPLC, GC, LC, or thin layer chromatography
10. Nuclear magnetic resonance spectroscopy
11. Assays to detect related proteins

--BIOLOGICAL ACTIVITY DETERMINATION
1. Specific identity testing such as western blot analysis or ELISA
2. Cytometric analysis
3. Neurovirulence testing
4. Serotyping
5. electrophoretic typing
6. Inactivation studies
7. Neutralization assays
8. Titrations

WHAT NEEDS TO ACCOMPANY PRODUCED VACCINES BEFORE ENTERING MARKET?
A description and results of all relevant in vivo and in vitro biological testing (bioassays)
ASSAYS MUST BE VALIDATED or validation of bioassay for vaccines
VACCINE RELEASE TESTING
Among all tests included in the specifications for batch release most have to be carried out on the product in its final container i.e. volume, pH, sterility, endotoxins, préservatives / adjuvants / excipient contents, qualitative and quantitative.
Leveraging Vaccine Manufacturing and Quality Control Platforms for New Modalities.
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