Protein Formulation and Delivery

Provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process. This book supplies an review of the mechanisms and associated causes of protein instability. It is for biotechnologists; drug regulatory affairs personnel; and others.

---

This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development.
Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability!
Organized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Delivery
includes a discussion of accelerated stability testing and its limitations in identifying stable formulations

details analytical methods commonly used in stability assessment and formulation development

stresses the importance of demonstrating the stability-indicating nature of an assay

describes the drug substance manufacturing process succinctly

examines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administration

covers aseptic processing in drug development and the potential development of a freeze-drying cycle

explores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage forms

discusses the physical and chemical characteristics of proteins in microsphere delivery systems

analyzes protein degradation mechanisms, and methods of detecting and monitoring degradation

explores formulations intended for injection, inhalation, and controlled delivery

and more!
Presenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers; and upper-level undergraduate and graduate students in these disciplines.