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VaccinesRicerca Biosciences, LLC vivarium consists of conventional animal rooms and BSL-2 compliant animal rooms. In-life and post-life staff are experienced in those techniques necessary to perform the FDA-recommended preclinical evaluation of vaccines. Studies in support of INDs (preclinical safety and biodistribution studies) are performed in both conventional and BSL-2 animal rooms; select efficacy studies are performed in BSL-2 animal rooms. Preclinical study protocols are written and performed to support the clinical regimen or CBER requirements; these are designed to demonstrate the safety of the formulation and method of administration proposed for the clinical study. These services are overseen by Dr. James Szabo who has extensive experience in preclinical vaccine development.
Ricerca Vaccine Studies:General toxicology/safety – designed and performed in support of the clinical regimen or CBER requirements for safety assessment. May be performed in mice, rats, rabbits, and/or primates. Local and systemic reactogenicity / toxicity assessed. May be single or multiple injections – intranasal, intradermal, subcutaneous, and intramuscular. Immunogenicity often assessed as part of the toxicity assessment. Vaccines for pediatric applications often performed in primates.
Biodistribution – designed and performed in support of the clinical regimen or CBER requirements. May be performed in mice, rats, rabbits and/or primates (biodistribution studies in primates often incorporated in the general toxicology/safety studies). Requires use of PCR for viral vectored vaccines, RNA and DNA vaccines, and recombinant viral vaccines.
Efficacy – only performed when an appropriate animal model is available. Requires immunization and challenge with live agent (i.e., influenza commonly assessed in ferrets).
Vaccine Types
ANIMAL SPECIES
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