Vaccine Preclinical Assessment

A large amount of vaccines is now being developed, the mechanism, adjuvants and delivery systems of which are being explored not only for traditional prophylactic use but also for therapeutic uses. Ensuring their safety, potency and quality is crucial because vaccines are generally administered to healthy individuals. Creative Biolabs offers a series of preclinical assessment to ensure these key attributes and enlighten the long and grueling path of vaccine development.

Vaccine Preclinical Assessment

In Vivo Assays

The animal model selection, which usually depends on the putative MOA and the target specificity of the investigational product, can not only determine the success of experiments but also impact the accuracy of study outcome. Ideally, to assess the potential biological activity with safety, the animal species should respond to the biological effects of the vaccine. Aside from using healthy animals, consideration should also be given to assessing the safety of therapeutic vaccines in the disease/injury model represented of the target patient population, recognizing that the species/model may not simulate all immunological aspects of that population.

The purpose of the test analysis is to consider the opportunities to replace and reduce the alternatives. It should be considered to include the use of in vitro or serological methods to reduce the number of animals in each group or to reduce the number of animal groups.

In Vitro Assays

Vaccine Preclinical Assessment

A wide range of quality control tests must be conducted for each batch of vaccines to ensure that their administration is safe and effective to produce protective immunity.

Potency assay is a crucial vaccine release assay. Historically, most potency assays typically rely on animals, but now new vaccines are measured by in vitro testing methods. Different approaches of potency assay are as follow [1]:

  • immunization-challenge test: immunological specificity, immune activity and the potential for immune toxicity
  • serological analyses: antibody concentration, antibody avidity (surrogate marker for memory), or cellular immune responses (T-cell proliferation and cytokine quantification), functional antibody assays (e.g., pathogen or toxin neutralizing)
  • cell-based assays: cellular immune responses in T-cells (e.g., cytotoxic CD8þ and CD4þ)
  • titration assays: measure potency indirectly

Relying on our professional team of experts, Creative Biolabs can provide excellent Preclinical assessment that meets your unique needs.

Reference

1. Josefsberg JO; et al. Vaccine process technology. Biotechnol Bioeng. 2012, 109(6): 1443-1460.


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