Biologicals
Biologicals are products derived from living organisms or containing complex biomolecules produced by biological systems. In medicine, biologicals encompass vaccines, therapeutic proteins such as monoclonal antibodies and recombinant enzymes, plasma-derived products, and various cell- and gene-based therapies. In agriculture, biologicals refer to products based on beneficial microorganisms or natural substances used as biopesticides, biofertilizers, or plant growth promoters. The term reflects the biological origin and complexity that distinguish these products from small-molecule drugs.
Manufacture of biologicals relies on living cells and sophisticated bioprocessing, including upstream fermentation or cell culture
Regulatory oversight for biologicals varies by jurisdiction but generally focuses on safety, efficacy, and manufacturing quality.
Impact and challenges: biologicals have transformed treatment for cancer, autoimmune and infectious diseases, and facilitated advances