Protein Formulation and Delivery will assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing:

• a comprehensive review of mechanisms and causes of protein instability in formulation development
• coverage of accelerated stability testing methods and relevant analytical methodsand
• an overview of the drug substance manufacturing process

Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. This Second edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.

Features:

• Discusses new, innovative scientific approaches including stabilization and delivery of proteins as single crystals, high through-put (robotic) formulation screening, and liposome approaches to protein formulation and delivery
• features new or expanded sections on rational choice of excipients for freeze drying, pulmonary delivery of insulin, and expiration dating and specification setting for biologics
• includes several chapters for scientists transitioning from working with small molecules to working with proteins

Contents

1. Overview of Protein Formulation and Delivery. Proetin Delivery (General Aspects)
2. Compare and Contrast Small Molecule and Large Molecule Formulation and Delivery
3. Chemical and Physical Considerations in Protein and Peptide Stability
4. Analytical Methods and Stability Testing of Biopharmaceuticals
5. The Importance of a Thorough Preformulation Study
6. Solution Formulation of Proteins/Peptides
7. Special Considerations in High Concentration Protein Formulations or Formulation for Implantable Devices
8. Freeze-Drying Concepts: The Basics
9. Rational Choice of Excipients for Use in Lyophilized Formulations
10. Formulation of Proteins for Pulmonary Delivery
11. Formulation of Proteins for Incorporation into Drug Delivery Systems
12. Needle Free Delivery Approaches
13. Single Crystal Formulation Approaches (Altus Approach)
14. High Throughput Screening-Transform Approach
15. Oral Delivery-Oral Heparin
16. Formulation of Proteins for Delivery into Liposome Formulations
17. Expiration Dating and Specification Setting for Biologics

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