Comprehensive approaches to preclinical evaluation of monoclonal antibodies and their next-generation derivatives.

ABSTRACT

Biotherapeutics hold great promise for the treatment of several diseases and offer innovative possibilities for new treatments that target previously unaddressed medical needs. Despite successful transitions from preclinical to clinical stages and regulatory approval, there are instances where adverse reactions arise, resulting in product withdrawals. As a result, it is essential to conduct thorough evaluations of safety and effectiveness on an individual basis. This article explores current practices, challenges, and future approaches in conducting comprehensive preclinical assessments to ensure the safety and efficacy of biotherapeutics including monoclonal antibodies, toxin-conjugates, bispecific antibodies, single-chain antibodies, Fc-engineered antibodies, antibody mimetics, and siRNA-antibody/peptide conjugates.