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 and downstream purification. Because the products are large, structurally intricate, and sensitive to processing and storage conditions, they can show batch-to-batch variability and require extensive quality control, analytical characterization, and adherence to good manufacturing practice. Many biologicals require cold-chain storage and carefully controlled distribution to maintain potency and safety.

Regulatory oversight for biologicals varies by jurisdiction but generally focuses on safety, efficacy, and manufacturing quality. Agencies such as the U.S. Food and Drug Administration, the European Medicines Agency, and others set standards for licensing, production controls, and post-market surveillance. Biosimilars—follow-on versions of approved biologicals—are subject to distinct regulatory pathways to demonstrate similarity in safety and efficacy. Ongoing pharmacovigilance monitors adverse events after approval.

Impact and challenges: biologicals have transformed treatment for cancer, autoimmune and infectious diseases, and facilitated advances in vaccines and rare-disease therapies. Challenges include high development and production costs, access and affordability, and complex logistics. The field continues to evolve with emerging modalities such as gene therapies and cellular therapies, alongside ongoing improvements in manufacturing and regulatory science.