Designing and Delivering Therapeutic Proteins

The discovery, use, and development of protein therapeutics has increased opportunities for drug-product development. Advancing the therapeutic potential of these protein-drug entities presents a challenge to formulation and delivery scientists.

The second edition of Protein Formulation and Delivery presents an updated review of recent research in the formulation and delivery of therapeutic proteins and peptides. The book contains expanded sections about protein characterization and formulation and several new chapters that focus on protein delivery.

One of the book's new chapters offers information to aid the rational choice of excipients for use during the freeze-drying process. The chapter also provides sound practical advice about bulking agents, buffers, and simple tests to predict the stability of freeze-dried formulations.

Two case studies of recombinant proteins are discussed in another new chapter about the preformulation development of protein drugs. The case studies illustrate the procedures for solubility and stability-screening studies for recombinant proteins.