2nd Edition

Pharmaceutical Formulation Development of Peptides and Proteins

Edited By Lars Hovgaard, Sven Frokjaer, Marco van de Weert Copyright 2013
    392 Pages 9 Color & 69 B/W Illustrations
    by CRC Press

    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.

    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


    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.