Introduction.- High Throughput Biophysical Approaches to Therapeutic Protein Development.- Techniques for Higher Order Structure Determination.- Biophysical Techniques for Protein Size Distribution Analysis.- Qualification of biophysical methods for the analysis of protein therapeutics.- Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and its Application to Enhance Developability Properties.- Application of Biophysics in Formulation, Process and Product Characterization: Selected Case Studies.- Biophysical Analysis in Support of Development of Protein Pharmaceuticals.- Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size.- Investigation of Non Conformance During Protein Therapeutic Manufacturing.- Higher order structure and protein aggregate characterization of protein therapeutics: perspectives from good manufacturing practices and regulatory guidance.- Index.
This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Organized to mimic biotherapeutic product lifecycle
Focuses on the applications of biophysics to different disciplines; in particular, focusing on protein therapeutic development
First fully comprehensive book to cover protein aggregation and the biophysical techniques used in the development lifecycle of biopharmaceuticals