Pharmaceutical Formulation Development of Peptides and Proteins: 2nd Edition (Hardback) book cover

Pharmaceutical Formulation Development of Peptides and Proteins

2nd Edition

Edited by Lars Hovgaard, Sven Frokjaer, Marco van de Weert

CRC Press

392 pages | 9 Color Illus. | 69 B/W Illus.

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Hardback: 9781439853887
pub: 2012-11-14
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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

Index

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MED008000
MEDICAL / Biochemistry
MED071000
MEDICAL / Pharmacology