VACCINE CANDIDATES HAVE A SPECIFIC DEVELOPMENT CYCLE THAT DIFFERS FROM OTHER PHARMACEUTICAL PRODUCTS
Aurigon fulfils all requirements and supports you during the in vitro or in vivo non-clinical development of your vaccine candidate by assessing:
- safety and immunogenicity
- the ability to provoke an immune response
- the application method.
Non-clinical toxicity testing of vaccines is designed to assess the safety of the vaccine prior to human clinical trials, identify potential toxicities and target organs, optimally determine a safe vaccine dose and identify an NOAL if needed.
Based on the requirements of the WHO guideline on non-clinical evaluation of vaccines, the parameters to be considered in designing animal toxicology studies are:
- the relevant animal species and strain
- dosing schedule and method of vaccine administration
- timing of end-point evaluation (e.g. sampling for clinical chemistry, antibody evaluation and necropsy).
The route of administration should correspond to that intended for use in the clinical trials. The toxicity assessment of the vaccine formulation can be carried out either in dedicated stand-alone toxicity studies or in combination with safety and activity studies that have toxicity end-points incorporated into their design. Studies should also include an assessment of local tolerance.
Our experienced staff and the GLP/GMP-certified testing facility ATRC ensure:
- study designs in accordance with the latest FDA/USP, EMA/Ph.EU., ICH and WHO guidelines
- multiple modes of administration including intranodal injection or intranasal administration
- animal handling according to the 2010/63/EU guideline and under the control of the Institutional Animal Care and Use Committee.