Biopharmaceutical Formulation and Delivery Technologies, Third Edition (3^rd Ed.)
Drugs and the Pharmaceutical Sciences Series

This third edition retains the basic scientific principles associated with the previous editions but brings to light the latest challenges associated with preparing, characterizing, formulating and delivering the ever-increasing types of biopharmaceutical molecules into therapeutics. New chapters include biopharmaceutical structure and drug delivery, protein design and engineering, quality by design for biopharmaceuticals, manufacturing and purification of biopharmaceuticals, immune response triggers by route of administration, proteins in the solid state, the challenge of biosimilars, and transdermal delivery of protein therapeutics.

Overview of Biopharmaceutical Formulation and Delivery. Biopharmaceutical Structure and Drug Delivery. Chemical Considerations in Protein and Peptide Stability. Physical Consideration in Protein and Peptide Stability. Analytical Methods and Stability Testing of Biopharmaceuticals. Protein Design and Engineering. Quality by Design for Biopharmaceuticals. Manufacturing and Purification of Biopharmaceuticals. Immune Response Triggers by Route of Administration. Preformulation and Characterization of Biopharmaceuticals. Solution Formulation Approaches and Stabilization Techniques. Transdermal Delivery of Protein Therapeutics. Concentrated Solution Formulation Development. Proteins in the Solid State: Glass Stabilization of Biopharmaceutical solids. Freeze-Drying Concepts: The Basics. Excipient Selection for Amorphous Powders. Spray Drying for Pulmonary Drug Delivery. Setting Specifications and Expiration Dating of Biopharmaceuticals. The Challenge of Biosimilars: Demonstrating Comparability and the Regulatory Path to Approval. Development of Drug Products: Similarities and Differences between Protein Biologics and Small Molecules.