Nonclinical Safety Assessment of Biologics, Including Vaccines

To date the most common forms of biologics in development have been mAb, recombinant proteins, and vaccines. However, numerous new modalities are now being developed. One of these new modalities is bispecific antibodies, which are able to recognize two distinct targets at the same time and might bridge two targets together, which presents an opportunity for therapeutic gains (such as bringing cancer cells within closer proximity to cytotoxic T lymphocytes).When one considers species selection, if both complementarity-determining regions (CDRs) do not have cross reactivity to the same species, one needs to understand how to appropriately assess the safety if the full pharmacological effect cannot be generated in one species. Therefore, these new biologic modalities offer great promise for the treatment of diseases but also challenges in developing the nonclinical toxicology testing paradigm to ensure the safety of the patients in the clinical trials. Keywords: antibody drug conjugates (ADCs); DNA vaccines; mAb; nonclinical safety testing programs; pharmacokinetics; stem cells; gene therapy