Drugs need to be formulated with scale-up in mind
Kurt D. Ristroph
Abstract
Formulation scale-up remains a major hurdle in drug development in part because preliminary formulation research efforts rarely consider the challenges of scaling up production for commercialization. This Perspective outlines considerations around scalability that can be incorporated into formulation design work in order to increase the chances of successful translation. Both technical (unit operations, excipient selection, scaling principles) and non-technical (funding, publications, and personnel) considerations are discussed, with a focus on lab-scale work by academic researchers.
Topics & Concepts
CommercializationScale (ratio)Perspective (graphical)Engineering ethicsWork (physics)Computer scienceManagement scienceScalabilityProduction (economics)Risk analysis (engineering)Engineering managementBusinessEngineeringMarketingEconomicsArtificial intelligencePhysicsMacroeconomicsDatabaseQuantum mechanicsMechanical engineeringInnovative Microfluidic and Catalytic Techniques InnovationComputational Drug Discovery MethodsProtein purification and stability