Overview

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.

Full Product Details

Author:   Eugene J. McNally ,  Eugene McNally ,  Jayne E. Hastedt (ALZA Corporation, Mountain View, California, USA) ,  Frank K. Bedu-Addo
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Edition:   2nd edition
Volume:   175
Dimensions:   Width: 15.20cm , Height: 2.20cm , Length: 22.90cm
Weight:   0.589kg
ISBN:  

9780849379499

ISBN 10:   0849379490
Pages:   376
Publication Date:   26 October 2007
Audience:   Professional and scholarly ,  Professional & Vocational
Replaced By:   9781498714129
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

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

Reviews

...written to assist the pharmaceutical scientist involved in the protein formulation and delivery processes...also...of use to students doing thesis research in these areas. Of particular value...are numerous insights into critical practical issues that impact the development of protein therapeutic products. -Pharmaceutical Research (for previous edition) ...concerns very timely topics...well written and organized. -Pharmaceutical Research (for previous edition) ...concise and informative...the authors have wisely chosen to illustrate their information with real-life examples and case studies. -Pharmaceutical Development and Technology (for previous edition) ...the most pertinent and readable summary of the familial ataxias that has been written to date...an excellent summary of all the knowledge an interested clinician in this area needs to know. -European Journal of Paediatric Neurology (for previous edition) ...a 'must read'....exceptionally well written....Highly recommended. -Journal of Controlled Release (for previous edition)

Author Information

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

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