Vaccines prevent infectious diseases, while vaccination is not without risk and adverse events are reported. Vaccines must undergo a preclinical safety assessment before being licensed to verify that the vaccine is safe and effective enough to be tested in humans. In most cases, preclinical safety assessments are extensive in order to gain sufficient data to reliably indicate not just the safety of a new vaccine, but also its potential potency, toxicity, stability, and pharmacokinetic properties. In addition, preclinical safety assessments allow scientists to model for potential drug-target interactions.
Importance of preclinical safety assessment
Preclinical assessments are designed to determine the in vitro and in vivo characteristics of vaccine candidates, including those related to safety and immunogenicity. Preclinical assessment collects data that details the development and production of the potential new vaccine. These data should be sufficient to support further clinical trials of the vaccine. Without strong evidence, the vaccine cannot move on from the preclinical to the clinical phase where human participants will be tested. Preclinical assessments in animals are valuable tools to determine the potential risk to vaccinees and to help develop protocols for subsequent clinical studies in humans. However, in all cases, there should be a clear rationale for performing safety testing in animals and the studies should be conducted in compliance with national and international laws for the protection of laboratory animals, biosafety requirements, and good laboratory practice (GLP).
What we offer
Potential safety concerns should be identified as early as possible during the development for vaccines to minimize investment risk. Alfa Chemistry provides toxicity and stability assessments as well as potency testing to ensure smooth vaccine development.
Why choose us
- Alfa Chemistry has a high-level, professional and experienced professional R&D team, equipped with various analysis and testing instruments.
- The laboratory management system complies with the international laboratory standard.
- The experiment period is short and the scheme is complete.
Our products and services are for research use only and cannot be used for any clinical purposes.