Computational and Experimental Design of Biopharmaceutical Formulations

Formulation development may be described as a bridge leading to the commercialization of promising molecules and represents an integral part of the drug commercialization process. Formulation development has a far-reaching impact on patient compliance and on the commercial success of a biologic. The increase in number and diversity of biologics entering the pipeline makes requisite a move away from trial-and-error, towards more rational formulation development. Computational and Experimental Design of Biopharmaceutical Formulations outlines available experimental and computational tools. It describes a rational approach to formulation design not limited by experimental design and extending to modern methods of computational modeling. These methods include the modeling of protein structure and dynamics, and of solution properties in the presence of proteins and excipients. The chapters in this book consider computational modeling of protein-solution interactions; the design of early-stage formulation studies; the design of late-stage formulation studies; automation, high-throughput and control; design of lyophilized formulations; and emerging technologies in the future formulation development Reviews methods for the design of biopharmaceutical formulationsConsiders both experimental and computational methods in concertDetails the design techniques specific to each step in protein formulation developmentDiscusses the predictive power of the methods used in formulation stability studiesDescribes and considers the potential of emerging models and experimental technologies INDICE: 1. Introduction 2. Computational modeling of protein-solution interactions 3. Design of early stage formulation studies 4. Design of late stage formulation studies 5. Automation, high throughput and control 6. Design of lyophilized formulations 7. Emerging technologies and formulation development of the future

• ISBN: 978-0-12-817348-0
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 230
• Fecha Publicación: 03/11/2020
• Nº Volúmenes: 1
• Idioma: Inglés