TOXICOLOGY OF BIOLOGICAL, BIOTECHNOLOGICAL, AND ATPMS PRODUCTS
The toxicology of biological, biotechnological, and ATPMS (Therapeutic Agents of Medicinal Products, Advanced Therapy Medicinal Products) products is a crucial field for evaluating the safety and efficacy of these products before their use in patients.
Biological products include medicines derived from living organisms, such as vaccines, monoclonal antibodies, and therapeutic proteins, while biotechnology products are created using biotechnology techniques, such as genetic engineering and cloning. In turn, advanced therapy medicinal products (ATMPs) encompass gene, cell, tissue, and combination therapies designed to address diseases at the molecular level.
The toxicological evaluation of all these products or their impurities based on in vitro, in vivo, or in silico studies is vital for identifying potential adverse effects and ensuring product safety.