Vaccine Assessment In Vitro Assays

Preventive vaccines are usually administered to healthy humans. Ensuring their safety and efficacy is therefore very crucial. Preclinical assessment is a prerequisite for the transfer of candidate vaccines from the laboratory to the clinic, including all aspects of animal testing, product characterization, proof of concept/immunogenicity studies, and safety testing prior to human clinical trials. Creative Biolabs offers a series of preclinical in vitro assays to ensure these key attributes and enlighten the long and grueling path of vaccine development.

Vaccine Safety Assessment

Vaccine Assessment In Vitro Assays

Clinical assessment of vaccines includes initial testing of candidate preparations. In vitro toxicity studies that conducted prior to the start of clinical trials (pre-clinical) identifies potential safety issues and helps to prevent possible harm to humans. Potential problems include the toxicity caused by the active ingredient or excipient, the reaction to trace impurities such as the production substrate, and the interaction between other vaccine components that are administered simultaneously.

Safety assessment that Creative Biolabs provide includes:

  • Inherent toxicity (caused directly by the vaccine ingredient). Such direct toxicity is the major concern in vaccine safety. Due to the low dosage and the limited number of administration in human, this toxic effect should be very rare. However, this direct toxicity will be evident in acute studies. [1] It is imperative to assess the intrinsic toxicity associated with excipients, adjuvants or preservatives in the final formulation.
  • Toxicity associated with the pharmacodynamic activity of the candidate vaccine or its components (e.g. cross-reactivity between autoantigens and vaccine-produced antibodies).
  • Toxicity of contaminants and impurities. The main goal is to remove all animal-derived substances to avoid the risk of introducing foreign substances, especially contamination from prion protein.

Vaccine Potency 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. Potency tests are available to assure that the vaccine produces the desired immunologic effect per specification. Biological-based manufacturing methods are filled with variable and potency testing is a tool to guarantee consistency of commercial vaccines. Historically, most potency assays typically rely on animals, but now new vaccines were measured by in vitro testing methods. [2] Different approaches of potency assay are as follow:

Vaccine Assessment In Vitro Assays
  • 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

For years, Creative Biolabs has consistently and effectively supported the vaccine development industry with a unique range of products and related services. Relying on our professional team of experts, Creative Biolabs can provide excellent Preclinical In Vitro Assays that meets your unique needs. Our experienced scientists are committed to helping you identify the most promising vaccine candidates and assisting you through to the later stages of development.

References

1. Verdier F. Non-clinical vaccine safety assessment. Toxicology. 2002, 174(1): 37-43.
2. Josefsberg JO; et al. Vaccine process technology. Biotechnol Bioeng. 2012, 109(6): 1443-1460.


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