The Role of Analytical Methods in Quality Control of Biologicals and Stability Testing of Biological Products

Large, intricate, heterogeneous molecules with higher-order structure make up the majority of biologic pharmaceuticals. They are created via a multistep process in living cells. Analyzing samples taken at specific times during the manufacturing process will help to monitor and control the process, ensuring the product's safety, quality, and efficacy. Currently, a sizeable share of the entire pharmaceutical sector is taken up by biologics. Proteins, carbohydrates, nucleic acids, cells, or tissues – or a complex combination of these elements – makes up the majority of biologic molecules. Hormones, blood products, cytokines, growth factors, vaccines, cell and gene therapies, recombinant therapeutic proteins, drugs from animal sources, and monoclonal antibody products are a few examples of biologics. Over time, biologics, additionally referred to as biotherapeutics, have developed into potent medications for the treatment of common and crippling diseases for which there may be no alternative therapy. Advanced biologics that offer individualized and targeted treatment for some incurable diseases include cell and gene treatments.