Product Page - Harber, Paul: Assuring (Not Discovering) Physical Stability of Therapeutic Protein Solutions
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Therapeutic Protein Solutions continue to be the fastest growing segment in human healthcare. These medicines are monoclonal antibodies, easily recognized by the body and designed to treat a number of chronic disease states. These antibodies are often formulated into solution and administered from a vial or prefilled syringe. Classic thermal stability studies, intended to define chemical stability over time have, at times, underestimated some of the physical sensitivities of this newer class of medicine. Transportation testing, based on ISTA profiles, helps the drug development team select robust formulations to assure successful commercialization.