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Status:
Available4.3
30 reviews
ISBN 10: 0849379490
ISBN 13: 9780849379499
Author: Eugene J McNally, Jayne E Hastedt
This title is intended to 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 methods, and 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. Because many developments in the field have emerged since the publication of the First Edition, 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.
Overview of Protein Formulation and Delivery
Protein 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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Tags: Eugene J McNally, Jayne E Hastedt, Protein, Formulation
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