Abstract

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

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