The term biologic refers to a diverse group of agents that are produced/obtained from biological sources and/or contain biological components. Much like synthetic pharmaceutical agents, biologics are investigated and developed with the aim of targeting and rectifying pathological mechanisms in the human body. However, while synthetic pharmaceuticals mainly affect cellular signaling through the modulation of receptor-ligand interactions, biologics can exert their effects in a myriad of ways through numerous different mechanisms. Biologic agents currently being used for research and therapeutic purposes range from molecules and peptides (e.g., antibodies and hormones), to intact and functional cells (e.g., stem cells), to 3-D structures such as tissues and organs. Because of this diversity, a firm and comprehensive understanding of how biologic agents will behave in different physiological and pathological conditions (e.g., environments, locations, and cell types) is critical to their effective usage and the prevention of side effects.
Key Phases of the Biologics Drug Discovery and Development Process
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES. PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS The listed regulatory status for products correspond to one of the below: IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use." ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagent. Analytical and performance characteristics are not established." CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. (Note: Devices may be CE marked to other directives.) RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures." LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only." No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.