Biologics standards

Biologics standards ensure medicines made from living organisms, like vaccines or antibody therapies, are safe, effective, and consistent. Regulatory agencies set strict guidelines for their production, quality control, and testing to prevent contamination and ensure each batch performs reliably. These standards involve detailed processes for manufacturing, labeling, and storage, helping healthcare providers and patients trust that biologic medicines meet high safety and efficacy criteria. In essence, they maintain the integrity and quality of complex biological products throughout their lifecycle.