Study protocols and reports for in-house preclinical studies will be written by Subject Matter Experts (SMEs) from the Research and Development Groups. Studies will be conducted by trained technicians within this group or at partner sites. Preclinical studies include pharmacokinetics (PK), absorption / distribution / metabolism / excretion (ADME), safety / toxicology, initial formulation and immunogenicity studies, passive transfer and protection, and efficacy studies. Additional studies include:
- Storage and distribution
- Challenge bank production
- Toxicology studies
- Passive transfer studies
- In vivo and in vitro immunoassay development, validation, product testing (BSL-2, -3)
- Efficacy studies BSL -2 and -3 (small and large animal models)
Drug Product for early stage preclinical support may be manufactured under non-cGMP conditions. However, later stage confirmatory or Current Good Laboratory Practice (cGLP) studies will be conducted with material manufactured in compliance with cGMPs. Product identity, strength, purity, and composition as well as stability will be determined.