Protein Formulation and Delivery

2. New Auflage 2007
ISBN: 978-0-8493-7949-9
Verlag: Taylor & Francis Inc

Buch, Englisch, 376 Seiten, Format (B × H): 160 mm x 235 mm, Gewicht: 599 g

Reihe: Drugs and the Pharmaceutical Sciences

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.

Zielgruppe

Academic, Professional, and Professional Practice & Development

Autoren/Hrsg.

McNally, Eugene J.

McNally, Eugene

Hastedt, Jayne E.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer Physiologie

Inhaltsverzeichnis

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

Über Autor(innen)

Eugene J. McNally, Eugene McNally, Jayne E. Hastedt, Jayne E. Hastedt