Pharmaceutical Formulation Development of Peptides and Proteins  book cover
2nd Edition

Pharmaceutical Formulation Development of Peptides and Proteins

ISBN 9781439853887
Published November 14, 2012 by CRC Press
392 Pages 9 Color & 69 B/W Illustrations

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Book Description

The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product.

Providing integrated solutions, this book discusses:

  • The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology
  • The physicochemical characteristics and stability of peptides and proteins
  • The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids
  • The opportunities and challenges of non-parenteral delivery of peptides and proteins
  • Risk factors, specifically the development of an unwanted immune response
  • A simulation approach to describe the fate of peptides and proteins upon administration to a biological system
  • The documentation required to register a protein-based drug

Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Table of Contents

Peptide Synthesis
Knud J. Jensen
Protein Expression
Nanni Din
Protein Purification
Lars Hovgaard, Lars Skriver, and Sven Frokjaer
Characterization of Therapeutic Peptides and Proteins
Marco van de Weert and Tudor Arvinte
Chemical Pathways of Peptide and Protein Degradation
Teruna J. Siahaan and Christian Schöneich
Physical Instability of Peptides and Proteins
Marco van de Weert and Theodore W. Randolph
Peptide and Protein Derivatives
Kristian Strømgaard and Thomas Høeg-Jensen
Peptides and Proteins as Parenteral Solutions
Michael J. Akers and Michael R. DeFelippis
Peptides and Proteins as Parenteral Suspensions: An Overview of Design, Development, and Manufacturing Considerations
Michael R. DeFelippis and Michael J. Akers
Rational Design of Solid Protein Formulations
Bingquan (Stuart) Wang and Michael J. Pikal
Peptide and Protein Drug Delivery Systems for Nonparenteral Routes of Administration
Ulrik Lytt Rahbek, František Hubálek, and Simon Bjerregaard
Immunogenicity of Therapeutic Proteins
Grzegorz Kijanka, Wim Jiskoot, Melody Sauerborn, Huub Schellekens, and Vera Brinks
Biosimulation of Peptides and Proteins
Tue Søeborg, Christian Hove Rasmussen, Erik Mosekilde, and Morten Colding-Jørgensen
Registration of Peptides and Proteins
Niamh Kinsella

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Lars Rovgaard is Principal Scientist for NovoNordisk A/S and a Professor at Copenhagen University, Denmark.

Sven Frokjaer is Dean of the Pharmaceutical Sciences Faculty at the University of Copenhagen Denmark. Marco van de Weert is an Associate Professor of Pharmaceutics and Analytical Chemistry at the University of Copenhagen.